Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Uses for Ocella

Drospirenone and ethinyl estradiol combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Ocella

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast Feeding

Drospirenone

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Boceprevir
• Cobicistat
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Paritaprevir
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Adrenal gland problem or
• Blood disorders (eg, hypercoagulopathy) or
• Breast cancer, active or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Heart rhythm problems (atrial fibrillation) or
• Hypertension (high blood pressure), uncontrolled or
• Kidney disease or
• Liver disease, including tumors or cancer or
• Migraine headache, new or worse or a new kind of headache or
• Problems with circulation or blood clots, now or in the past or
• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Cervical cancer or intraepithelial neoplasia or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Depression, history of or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
• Gallbladder disease or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper use of Ocella

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day, after the evening meal or at bedtime. You may take this medicine with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (eg, another pill, patch, vaginal ring) to using Yasmin® or Yaz®, take the medicine on the day you would have usually taken your next pill If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to using Yasmin® or Yaz®, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you have a miscarriage or abortion after the second trimester or if you gave birth and chose not to breastfeed, you may start using this medicine after 4 weeks to prevent the risk of having blood clots.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy), PMDD, or acne:
    • Adults and teenagers—
      • Yasmin®: One yellow tablet (active) taken at the same time each day for 21 consecutive days followed by one white (inert) tablet daily for 7 days per menstrual cycle.
      • Yaz®: One pink tablet (active) taken at the same time each day for 24 consecutive days followed by one white (inert) tablet daily for 4 days per menstrual cycle.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• Yasmin®:
  • If you miss one yellow pill: Take the pill as soon as possible and take the next pill at your regular schedule.
  • f you miss two yellow pills in week 1 or 2: Take the two pills as soon as possible and the next two pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • If you miss two yellow pills in week 3 or 4, or if you miss three or more yellow pills in a row in any week:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss your menstrual period 2 months in a row, check with your doctor because you might be pregnant.
  • If you miss any of the seven white pills in week 4: Throw away the pills you missed. Continue taking one pill a day until you finish the pack.
• Yaz®:
  • If you miss one light pink tablet: Take the tablet as soon as possible and take the next tablet at your regular schedule. This means that you may take 2 pills in 1 day. Continue taking one tablet a day until you finish the pack. You do not need to use another form of birth control if you have sex.
  • If you miss two light pink tablets in Week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • If you miss two light pink tablets in Week 3 or 4:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
    • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
  • If you miss three or more light pink tablets:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
    • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
  • If you miss four white tablets in Week 4: Throw out the pill you missed. Keep taking one tablet each day until the pack is empty. You do not need to use another form of birth control if you have sex.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Ocella

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, and check with your doctor immediately.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills containing drospirenone, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems, especially in the first 6 months of use. This risk may be higher if you are using a birth control pill containing drospirenone and ethinyl estradiol. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained trouble breathing, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Ocella

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Breast pain or tenderness
• headache, severe and throbbing
• heavy non-menstrual vaginal bleeding
• irregular menstrual periods
• nausea
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Less common

• Longer or heavier menstrual periods
• unusual tiredness or weakness
• vomiting

Incidence not known

• Chills
• clay-colored stools
• dark urine
• difficulty with breathing
• dizziness
• fever
• headache
• itching
• loss of appetite
• pain in the chest, groin, or legs, especially the calves
• rash
• slurred speech
• stomach pain
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• unpleasant breath odor
• unusual tiredness or weakness
• vision changes
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Crying
• decreased interest in sexual intercourse
• delusions of persecution, mistrust, suspiciousness, or combativeness
• false or unusual sense of well-being
• inability to have or keep an erection
• irritability
• loss in sexual ability, desire, drive, or performance
• mental depression
• quick to react or overreact emotionally
• rapidly changing moods
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Commonly used brand name(s)

In the U.S.

• Gianvi
• Loryna
• Nikki
• Ocella
• Syeda
• Vestura
• Yasmin
• YAZ
• Yaz 28
• Zarah

What is ocrelizumab?

Ocrelizumab is a recombinant humanized monoclonal antibody.

Ocrelizumab intravenous infusion is a prescription medicine used to treat primary progressive multiple sclerosis in adults.

Ocrelizumab is also used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Warnings

Ocrelizumab may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Some side effects may occur during the ocrelizumab infusion or up to 24 hours later. Tell your caregiver if you feel dizzy, nauseated, itchy, or have chest tightness, throat irritation, or trouble breathing.

Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, skin sores or blisters, itching, tingling, burning pain, or problems with speech, thought, vision, or muscle movement.

If you’ve ever had hepatitis B, it may become active or get worse while you are using or after you stop using ocrelizumab. You may need frequent liver function tests for several months.

Before taking this medicine

You should not be treated with ocrelizumab if you are allergic to it, or if you have:

• active infection with hepatitis B.

Your doctor may perform tests to make sure you do not have hepatitis B or other infections.

You should not receive any “live” or “live-attenuated” vaccine within the 4 weeks before you start treatment with ocrelizumab. If you need a “non-live” vaccine, you should receive it at least 2 weeks before you start treatment with ocrelizumab.

Also tell your doctor if:

• you have ever had colitis or inflammatory bowel disease;
• you have any type infection;
• you are a carrier of hepatitis B; or
• you have ever used medicine that can weaken your immune system.

Using ocrelizumab may increase your risk of developing certain types of cancer, such as breast cancer. Ask your doctor about your specific risk.

It is not known whether ocrelizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

If you are pregnant, you will need to tell your baby’s doctor if you used ocrelizumab during pregnancy, especially before the baby receives any childhood vaccines.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ocrelizumab on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How is ocrelizumab given?

Ocrelizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Your first dose of ocrelizumab will be split into 2 separate infusions given 2 weeks apart. The following doses will be given once every 6 months.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ocrelizumab.

This medicine must be given slowly, and the infusion can take from 2 to 3.5 hours to complete.

You may be given other medications to help prevent serious side effects of ocrelizumab.

You will be watched closely for at least 1 hour after receiving ocrelizumab, to make sure you do not have an allergic reaction to the medication.

Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you’ve ever had hepatitis B, this virus may become active or get worse during treatment with ocrelizumab or in the months after you stop using this medicine. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 300 mg IV followed 2 weeks later by a second 300 mg IV infusion
Maintenance dose: 600 mg IV every 6 months

RECOMMENDED INFUSION RATES:
INFUSION 1: (300 mg of this drug in 250 mL 0.9% sodium chloride injection): Start at 30 mL/hr and increase by 30 mL/hr every 30 minutes to a maximum of 180 mL/hr; duration of 2.5 hours or longer
INFUSION 2 (TWO WEEKS LATER): (300 mg of this drug in 250 mL 0.9% sodium chloride injection): Start at 30 mL/hr and increase by 30 mL/hr every 30 minutes to a maximum of 180 mL/hr; duration of 2.5 hours or longer
SUBSEQUENT INFUSIONS:
-OPTION 1 (600 mg of this drug in 500 mL 0.9% sodium chloride injection): Start at 40 mL/hr and increase by 40 mL/hr every 30 minutes to a maximum of 200 mL/hr; duration of 3.5 hours or longer
OR
-OPTION 2 if no prior serious infusion reaction (600 mg of this drug in 500 mL 0.9% sodium chloride injection): Start at 100 mL/hr for the first 15 minutes and increase to 200 mL/hr for the next 15 minutes; increase to 250 mL/hr for the next 30 minutes; increase to 300 mL/hr for the remaining 60 minutes; duration of 2 hours or longer

Uses:
-For relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
-Primary progressive MS

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ocrelizumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving ocrelizumab?

Do not receive a “live” vaccine while using ocrelizumab or within 4 weeks before you start using ocrelizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Do not receive a “non-live” vaccine while using ocrelizumab or within 2 weeks before you start using this medicine. Non-live vaccines include hepatitis A, polio, rabies, and a yearly flu shot.

Ocrelizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ocrelizumab may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, itchy, warm and tingly, or if you have a skin rash, headache, fast heartbeats, chest tightness, pain or irritation in your throat, or trouble breathing.

Call your doctor at once if you have:

• diarrhea or more frequent bowel movements than usual, or black, tarry, sticky or bloody stools, or stomach pain or tenderness;
• fast heart beats, tiredness;
• headache, nausea, dizziness;
• itchy skin, rash, hives;
• fever, chills, cough;
• throat pain or irritation;
• wheezing, breathing problem, feeling short of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• skin sores, blisters, pus, or oozing;
• cold sores or fever blisters on or around your lips;
• nerve pain (tingling, burning pain, “pins and needles” feeling);
• mood or behavior changes, confusion, memory problems;
• weakness on one side of your body; or
• problems with speech, vision, or muscle movement.

Your ocrelizumab treatments may be delayed or permanently discontinued if you have certain side effects.

Common ocrelizumab side effects may include:

• skin infections;
• reactions to an injection; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is Ocrevus infusion?

Ocrevus (ocrelizumab) is a treatment for relapsing and progressive multiple sclerosis (MS) to help reduce relapses and slow disability progression. Ocrevus binds and destroys B cells, which are involved in MS progression. Ocrevus is used for primary progressive MS and relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Ocrevus active ingredient is ocrelizumab.

Multiple sclerosis is a disabling condition caused by your immune system mistakenly attacking and damaging the protective cover (myelin sheath) of nerves in your brain, spinal cord, and optic nerves. B cells and T cells are part of the immune system that causes damage to the myelin sheath.

Ocrevus mechanism of action is believed to be binding to proteins (antigens) called CD20 on the outside of  B cells and destroying them. Fewer B cells in the body mean less damage to the nerves which helps to reduce the number of relapses and brain lesions and to slow the progression of disability. B cells, a type of white blood cell, are part of the immune system that causes MS by damaging the myelin sheath.  Ocrevus is a CD20-directed cytolytic antibody.

Ocrevus infusion is given over a couple of hours, and Ocrevus Zunovo is given as an injection under the skin (subcutaneous injection) for approximately 10 minutes. Both are given twice a year as a maintenance dose by your healthcare professional. 

What is Ocrevus used for?

Ocrevus infusion is an MS medicine FDA approved to be used for:

• relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• primary progressive MS in adults.

Ocrevus received FDA approval in March 2017; it is given as an infusion. Ocrevus Zunovo became FDA-approved on September 13, 2024. It contains ocrelizumab and hyaluronidase and is given as a subcutaneous injection.

Ocrevus Side Effects

Common Ocrevus infusion side effects

When used for RMS, common Ocrevus side effects are infusion reactions and cold symptoms such as stuffy nose, sneezing, and sore throat, which are symptoms of an upper respiratory tract infection.  These occurred in 10% or more patients and greater than Rebif, 

Common Ocrevus side effects when used for PPMS are lower respiratory tract infections, cold symptoms such as stuffy nose, sneezing, and sore throat, which are symptoms of an upper respiratory tract infection, skin infections, and also infusion reactions.  These occurred ≥10% and > placebo).

Serious Ocrevus infusion side effects

Ocrevus may cause serious allergic reactions, including severe allergic reactions, brain infections (progressive multifocal leukoencephalopathy (PML)), other serious infections, Hepatitis B virus (HBV) reactivation, and decreased immunoglobulins.

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Ocrevus may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, itchy, warm and tingly, or if you have a skin rash, headache, fast heartbeats, chest tightness, pain or irritation in your throat, or trouble breathing.

Call your doctor at once if you have:

• diarrhea or more frequent bowel movements than usual, or black, tarry, sticky or bloody stools, or stomach pain or tenderness;
• fast heartbeats, tiredness;
• headache, nausea, dizziness;
• itchy skin, rash, hives;
• fever, chills, cough;
• throat pain or irritation;
• wheezing, breathing problem, feeling short of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• skin sores, blisters, pus, or oozing;
• cold sores or fever blisters on or around your lips;
• nerve pain (tingling, burning pain, “pins and needles” feeling);
• mood or behavior changes, confusion, memory problems;
• weakness on one side of your body; or
• problems with speech, vision, or muscle movement.

Your Ocrevus treatments may be delayed or permanently discontinued if you have certain side effects.

These are not all the possible side effects of this medication. Call your doctor for medical advice about side effects.

What is the Ocrevus copay card?

With the Ocrevus copay card, you may pay as little as $0, depending on your health insurance plan.  Click on Ocrevus Co-pay Cards and Price Guide for links to the Ocrevus Co-pay Program and the start form.

Warnings

Infusion reactions: Infusion reactions are a side effect of Ocrevus, which can be serious and may require you to be hospitalized. When you receive your Ocrevus infusion you will be monitored for signs and symptoms of an infusion reaction, and infusion will be interrupted or stopped if any symptoms occur, and appropriate supportive treatment will be administered if necessary.

Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin, trouble breathing, nausea, shortness of breath, rash, throat irritation or pain, headache, fatigue, hives, feeling faint, swelling of the throat, fast heartbeat, tiredness, fever, dizziness, coughing or wheezing or redness on your face (flushing), injection site pain, swelling and redness.

Injection reactions can happen during or up to 24 hours after administration. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection.

Infection: Infections are a common side effect. Ocrevus increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection, including fever, chills, or a cough that does not go away or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus.

Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:

• thinking
• eyesight
• strength
• balance
• weakness on 1 side of your body
• using your arms or legs

Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving this medicine

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See “Warnings”
• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have had a recent vaccination or are scheduled to receive any vaccinations.

You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened.

When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus talk to your healthcare provider.

Pregnancy 

Tell your healthcare provider if you are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if this medicine will harm your unborn baby. You should use birth control (contraception) during treatment with this medication and for 6 months after your last infusion. Talk with your healthcare provider about what birth control method is right for you during this time.

There is a pregnancy registry for women who take Ocrevus during pregnancy. If you become pregnant while receiving this medication, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Ocrevus Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting www.Ocrevuspregnancyregistry.com.

If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving this medication so they can decide when your baby should be vaccinated.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medication.

Who should not receive Ocrevus?

• Do not receive this medication if you have an active hepatitis B virus (HBV) infection.
• Do not receive this medication if you have had a life-threatening allergic reaction to it. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past. See “What are the ingredients in Ocrevus?” below for a complete list of ingredients.

​​How should I receive Ocrevus?

• Ocrevus is given through a needle placed in your vein (intravenous (IV) infusion) in your arm.
• Before treatment, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions. See the Warnings section.
• Your first full dose of Ocrevus will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours and 30 minutes.
• Your next doses of this medication will be given as 1 infusion every 6 months. These infusions will last about 2 hours to 3 hours and 30 minutes depending on the infusion rate prescribed by your healthcare provider.

Ocrevus Dosing information

Ocrevus is given by intravenous infusion

Initial Ocrevus dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion

Maintenance Ocrevus doses: 600 mg intravenous infusion every 6 months 

General dosing information:

• Must be diluted before administration.
• You will be monitored closely during and for at least one hour after infusion.
• Before your first treatment you should have hepatitis B virus and quantitative serum immunoglobulin screening 
• Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) before each infusion.

Ocrevus J code and billing codes

Ocrevus J code is J2350

Ocrevus is available as Ocrelizumab 300 mg single-dose vial 

NDC code 50242-150-01 (10 digit) or 50242-0150-01 (11 digit)

Multiple sclerosis ICD-10-CM G35

What happens if I miss a dose?

If you miss a dose of Ocrevus, call your healthcare provider and reschedule your appointment to receive your missed dose as soon as possible. Do not wait until your next planned dose. After you receive your missed dose, reschedule your next dose for 6 months after your missed dose. Ocrevus doses must be separated by a minimum of 5 months.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about other immunosuppressive or immune-modulating drugs that you have taken or are currently taking.

Ocrevus Package Insert 

Review the Ocrevus Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

• Store Ocrevus vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light.
• Do not freeze or shake
• Use prepared Ocrevus infusion solution immediately. If not used immediately, store up to 24 hours in the refrigerator at 2°C to 8°C (36°F to 46°F) and 8 hours at room temperature up to 25°C (77°F), which includes infusion time. In the event an intravenous infusion cannot be completed the same day, discard the remaining solution.

Keep out of sight and reach of children.

What are the ingredients in Ocrevus?

Active ingredient: ocrelizumab.

Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate.

Company

Ocrevus is manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.

Ocrevus and Ocrevus Zunovo are manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.

Ocrevus Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ocrevus.Ocrevus (ocrelizumab) – Genentech, Inc.

What is Ofev?

Ofev (nintedanib) is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF), interstitial lung disease when lung fibrosis is worsening, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) to help slow the decline in lung function. Ofev capsules are taken twice daily.

Ofev is used in people with diseases that cause scar tissue (fibrosis) to form deep within the lungs. The scar tissue thickens and becomes stiff over time, making it harder for the lungs to work. Decreased lung function can make it hard to breathe. Other medical problems can occur when the brain, heart, and other organs do not get enough oxygen.

Ofev is not a cure for IPF or ILD, but this medicine can slow the effects of these diseases on your lungs.

Ofev mechanism of action is an inhibitor of multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Some of these kinases are involved in fibrotic tissue remodeling in interstitial lung diseases, so blocking the kinases helps slow lung disease progression.

Is Ofev chemotherapy? No, Ofev is not chemotherapy. Another brand of nintedanib called Vargatef is used for cancer and is a targeted therapy.

Ofev side effects

Common side effects

Common Ofev side effects may include:

• nausea, vomiting, loss of appetite;
• stomach pain;
• diarrhea, weight loss;
• increased blood pressure;
• headache; or
• abnormal liver function tests.

Serious Ofev side effects 

Get emergency medical help if you have signs of an allergic reaction to Ofev with symptoms of hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;
• severe stomach pain, bloating, or tenderness;
• bleeding from your rectum or blood in your stools;
• easy bruising or bleeding, any wound that will not heal;
• fever, chills, cough with mucus, chest pain, feeling short of breath;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – stomach pain (upper right side), loss of appetite, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

Liver problems may be more likely in women, in people who weigh less than 143 pounds (65 kilograms), and in people of Asian descent.

Your doses may be delayed if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Ofev can cause birth defects or death in an unborn baby. Avoid getting pregnant while you are using this medicine and for at least 3 months after your last dose. Use effective birth control, with an extra barrier method (condom, diaphragm, cervical cap, contraceptive sponge).

Before taking this medicine

To make sure Ofev is safe for you, tell your doctor if you have ever had:

• liver disease;
• heart problems;
• a blood clot;
• bleeding problems (in you or a family member);
• surgery on your stomach or intestines;
• diverticulitis;
• if you smoke; or
• if you take a blood thinner such as warfarin (Coumadin, Jantoven).

You may need to have a negative pregnancy test before starting this treatment.

Nintedanib can cause birth defects or death in an unborn a baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

If you use hormonal birth control (birth control pills, injections, implants, skin patches, or vaginal rings), also use a barrier form of birth control to prevent pregnancy while taking Ofev. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge).

Ofev may affect fertility (your ability to have children) in women. However, it is important to use birth control to prevent pregnancy because this medicine can harm an unborn baby.

You should not breastfeed while using this medicine.

Ofev is not approved for use by anyone younger than 18 years old.

How should I take Ofev?

Ofev is usually taken 2 times per day, every 12 hours. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ofev.

Take with food if you have no liver impairment and apart from food if you have mild hepatic impairment. Take capsules with a full glass of water.

Swallow the capsule whole and do not crush, chew, break, or open it.

Take your doses at regular intervals, usually every 12 hours.

Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may need to take medication to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking Ofev. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev.

You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. Your next few doses may be delayed based on the results.

Store this medicine in the original container at room temperature, away from moisture and heat.

Ofev Dosing information

Usual Adult Dose (no hepatic impairment)

Recommended Ofev dose 150 mg orally every 12 hours apart from food. Maximum dose: 300 mg/day.

Usual Adult Dose (mild hepatic impairment)

Recommended dosage in patients with mild hepatic impairment (Child-Pugh A): 100 mg taken orally twice daily, approximately 12 hours taken with food. 

Ofev is not recommended for use in patients with moderate or severe hepatic impairment.

General Ofev dosing information

• Do not chew, crush, or open capsules. If you or your caregiver accidentally comes in contact with the content of the capsule, wash your hands well right away.
• Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions.
• Conduct liver function tests before starting therapy.
• Conduct a pregnancy test in females of reproductive potential before starting therapy.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Do not take more than 300 milligrams of nintedanib in one day.

What to avoid

Smoking can make Ofev less effective. Avoid smoking while taking this medicine, or try to quit before you start this treatment.

Avoid taking an herbal supplement containing St. John’s wort.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with nintedanib may cause you to bruise or bleed easily.

What other drugs will affect Ofev?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is ofloxacin?

Ofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Ofloxacin is used to treat bacterial infections of the skin, lungs, prostate, or urinary tract (bladder and kidneys). Ofloxacin is also used to treat pelvic inflammatory disease and Chlamydia and/or gonorrhea.

Fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible. Ofloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Ofloxacin may also be used for purposes not listed in this medication guide.

Ofloxacin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Ofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking ofloxacin and call your doctor at once if you have:

• low blood sugar–headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
• nerve symptoms in your hands, arms, legs, or feet–numbness, weakness, tingling, burning pain;
• serious mood or behavior changes–nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
• signs of tendon rupture–sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, ofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using ofloxacin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• the first sign of any skin rash, no matter how mild;
• muscle weakness, breathing problems;
• little or no urination;
• a seizure (convulsions);
• increased pressure inside the skull–severe headaches, ringing in your ears, vision problems, pain behind your eyes; or
• liver problems–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of ofloxacin may include:

• nausea, constipation, diarrhea;
• dizziness; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Ofloxacin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, ofloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Before taking this medicine

You should not use ofloxacin if you are allergic to ofloxacin or other fluoroquinolones (ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and others).

Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles’ tendon of the heel. This can happen during treatment or up to several months after you stop taking ofloxacin. Tendon problems may be more likely in certain people (children and older adults, or people who use steroid medicine or have had an organ transplant).

Tell your doctor if you have ever had:

• tendon problems, bone problems, arthritis, or other joint problems;
• blood circulation problems, aneurysm, narrowing or hardening of the arteries;
• heart problems, high blood pressure;
• a genetic disease such as Marfan syndrome or Ehler’s-Danlos syndrome;
• diabetes;
• a muscle or nerve disorder, such as myasthenia gravis;
• liver or kidney disease;
• a seizure;
• long QT syndrome (in you or a family member); or
• low levels of potassium in your blood (hypokalemia).

Ofloxacin is not approved for use by anyone younger than 18 years old.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

How should I take ofloxacin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take ofloxacin with water, and drink extra fluids to keep your kidneys working properly.

You may take ofloxacin with or without food, at the same time each day.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Ofloxacin will not treat a viral infection such as the flu or a common cold.

Do not share ofloxacin with another person.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use ofloxacin.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ofloxacin?

Avoid driving or hazardous activity until you know how ofloxacin will affect you. Your reactions could be impaired.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Ofloxacin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

What other drugs will affect ofloxacin?

Some medicines can make ofloxacin much less effective when taken at the same time. If you take any of the following medicines, take your ofloxacin dose 2 hours before or 2 hours after you take the other medicine.

• antacids that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate);
• didanosine (Videx) powder or chewable tablets; or
• vitamin or mineral supplements that contain calcium, iron, magnesium, or zinc.

Tell your doctor about all your other medicines, especially:

• theophylline;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”;
• insulin or oral diabetes medicine (check your blood sugar regularly);
• heart rhythm medication;
• medicine to treat depression or mental illness;
• steroid medicine (such as prednisone); or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is ofloxacin otic?

Ofloxacin is an antibiotic that treats infections caused by bacteria.

Ofloxacin otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofloxacin otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).

Ofloxacin otic may be used on a long-term basis to treat an infection that causes a hole in the ear drum (ruptured ear drum) in adults and children who are at least 12 years old.

Ofloxacin may also be used for purposes not listed in this medication guide.

Ofloxacin otic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, rash, itching; slow heart rate, weak pulse, fainting; difficult breathing, slow breathing (breathing may stop); swelling of your face, lips, tongue, or throat.

ofloxacin otic may cause serious side effects. Stop using ofloxacin otic and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild; or
• ear drainage, discharge, or worsening pain.

Common side effects of ofloxacin otic may include:

• headache;
• dizziness; or
• mild ear pain or itching after using the ear drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use ofloxacin otic if you are allergic to ofloxacin or similar antibiotics, such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), or norfloxacin (Noroxin).

FDA pregnancy category C. It is not known whether ofloxacin otic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

How should I use ofloxacin otic?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Shake the medicine well just before each use.

You may warm the medicine before use by holding the bottle in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.
• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.
• Stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.
• If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) four to five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor’s instructions.

Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have new symptoms.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after your treatment is finished.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of ofloxacin otic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while taking ofloxacin otic?

This medicine is for use only in the ears. Avoid getting the medicine in your eyes, mouth, and nose, or on your lips. Rinse with water if this medicine gets in or on these areas.

Do not use other ear medications unless your doctor tells you to.

What other drugs will affect ofloxacin otic?

It is not likely that other drugs you take orally or inject will have an effect on ofloxacin used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What is Ojjaara?

Ojjaara (momelotinib) may be used to treat adults with certain types of myelofibrosis (MF) who have anemia. 

Myelofibrosis is a rare blood cancer where the bone marrow becomes scarred, preventing it from producing enough healthy blood cells. Over time, abnormal blood cells build up and replace normal ones. The exact cause is unknown, but it’s linked to a problem with a specific cell signaling pathway, called the JAK-STAT pathway. Treatment usually involves managing symptoms such as anemia and an enlarged spleen.

Ojjaara’s mechanism of action involves targeting and blocking specific enzymes called JAK1, JAK2, and a mutated form of JAK2. These enzymes are involved in regulating blood cell production and inflammation. Mutations in these enzymes have been associated with certain blood cancers like several leukemias, lymphomas, and myeloproliferative diseases. Ojjaara is not chemotherapy, it is a targeted treatment. 

Ojjaara gained FDA approval on September 15, 2023. There is no Ojjaara generic. Ojjaara belongs to the drug class known as multikinase inhibitors; specifically, it is a Janus Kinase inhibitor.

Ojjaara side effects

The most common side effects of Ojjaara include:

• low platelet counts
• dizziness
• bleeding
• diarrhea
• bacterial infections
• nausea
• tiredness.

Serious side effects and warnings

Ojjaara may cause the following serious side effects.

Serious and fatal infections. People who take Ojjaara may develop serious infections that can lead to death, such as bacterial and viral infections, including COVID-19. If you have an active infection, your healthcare provider should not start treatment with Ojjaara until your infection is gone. If you have had hepatitis B for a long time (chronic), Ojjaara may cause your hepatitis B to become active again, and your healthcare provider will check your blood for active hepatitis B before starting treatment. Your healthcare provider will monitor you and treat you for any infections that you get during treatment with Ojjaara. Tell your healthcare provider right away if you develop any of the following symptoms of infection:

• fever
• diarrhea
• chills
• vomiting
• cough
• pain or burning feeling when passing urine
• breathing problems.

Low platelet and white blood cell counts. Ojjaara may cause new or worsening low platelet and white blood cell counts. Low platelet counts may increase your risk for bleeding and low white blood cell counts may increase your risk for infection. Your healthcare provider will do blood tests to check your blood counts before you start taking Ojjaara, and during treatment. Tell your healthcare provider right away if you have any signs of bleeding during treatment with Ojjaara, including:

• unusual bleeding
• bruising
• black or tarry stools.

Liver problems. Ojjaara may cause new or worsening increased liver enzymes and bilirubin in your blood. Your healthcare provider will check your liver enzymes before starting treatment, every month for the first 6 months of treatment, and then as needed during treatment with Ojjaara. Your healthcare provider may stop treatment with Ojjaara if your liver enzymes increase. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:

• tiredness
• dark urine
• loss of appetite
• yellowing of your skin or the white part of your eyes
• pain in your right upper stomach area (abdomen).

Major cardiovascular events such as heart attack, stroke, and death. Major cardiac events have happened, especially in people with cardiac risk factors and who are current or past smokers, taking another Janus kinase (JAK) inhibitor to treat rheumatoid arthritis. Ojjaara is in the JAK family of medicines. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Ojjaara, including:

• discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech.

Blood clots. Blood clots in the veins of the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis, and may be life-threatening. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Ojjaara, including:

• swelling, pain, or tenderness in one or both legs
• sudden, unexplained chest pain
• shortness of breath or difficulty breathing.

New cancers. New cancers, including lymphoma and other cancers, except non-melanoma skin cancer, have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis. The risk of new cancers is further increased in people who smoke or who smoked in the past.

It is not known if Ojjaara is safe and effective for children.

These are not all of the possible side effects of Ojjaara. Call your doctor for medical advice about side effects.

Before taking

Do not take Ojjaara if you are allergic to momelotinib, Ojjaara, or any of the inactive ingredients in the Ojjaara tablets.

Taking Ojjaara can increase your risk of life-threatening medical problems, including serious infections, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you’ve had:

• a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis B)
• any type of cancer
• chronic lung disease
• heart problems
• a heart attack, stroke, or blood clot
• liver disease
• if you’ve ever smoked
• if you are scheduled to receive any vaccine.

Before taking Ojjaara, tell your healthcare provider about all of your medical conditions, including if
you:

• have an infection or have any of the following symptoms: fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination
• have or have had hepatitis B
• have or have had liver problems
• have had a heart attack, or have or have had other heart problems, or stroke
• have or have had a blood clot
• smoke or were a smoker in the past
• have or have had any other cancers
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Ojjaara may harm your unborn baby. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of Ojjaara. Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment.

Breastfeeding

It is not known if Ojjaara passes into your breast milk. You should not breastfeed during treatment and for 1 week after the last dose of Ojjaara. Talk to your healthcare provider about the best way to feed your baby during this time

How should I take Ojjaara?

Take Ojjaara exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ojjaara without first talking to your healthcare provider. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have certain side effects.

• Ojjaara is a tablet that is taken by mouth once a day.
• Ojjaara tablets may be taken with or without food.
• Swallow the tablets whole. Do not cut, crush, or chew tablets.
• Your healthcare provider will do blood tests before you start taking Ojjaara and during treatment.

Ojjaara dosing information

• The usual dosage is Ojjaara 200mg once daily.
• In people with severe liver disease (Child-Pugh Class C), your healthcare provider may reduce your dose.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose and take your next dose the following day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.

What happens if I overdose?

If you take too much Ojjaara, call your healthcare provider or go to the nearest emergency room right away and take your bottle of Ojjaara with you.

What other drugs will affect Ojjaara?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Ojjaara with certain other medicines may affect the amount of it or the other medicines in your blood and may increase your risk of side effects. Tell your doctor if you take:

• Organic Anion Transporting Polypeptide (OATP)1B1/B3 inhibitors, such as atazanavir, clarithromycin, cobicistat, cyclosporine
• Breast Cancer Resistance Protein (BCRP) substrates, such as prazosin, sulfasalazine, and rosuvastatin

Know the medicines you take. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store Ojjaara at room temperature between 68°F to 77°F (20°C to 25°C).

Keep it in its original bottle. The Ojjaara bottle contains a desiccant packet to help keep your tablets dry (protect from moisture). Keep the desiccant in the bottle. Tightly close the bottle after you take your dose.

Keep out of the reach of children.

Ojjaara ingredients

The ingredients of Ojjaara made by GSK are as follows:

Active ingredient: momelotinib dihydrochloride monohydrate

Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, silicon dioxide, and sodium starch glycolate. Film coating: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

Available as Ojjaara 100 mg tablets, Ojjaara 150 mg tablets, and Ojjaara 200 mg tablets.

What is olanzapine?

Olanzapine (brand name Zyprexa) is an atypical antipsychotic that may be used to treat adults and adolescents aged 13 and older with schizophrenia or bipolar I disorder. For bipolar I disorder, it may be used:

• alone for manic or mixed episodes, or in combination with lithium or valproate
• with fluoxetine for depressive episodes in people aged 10 and older.

For treatment-resistant depression, olanzapine is used in combination with fluoxetine (Symbyax).

Olanzapine is available as oral tablets, orally disintegrating tablets, or an injection that is given into a muscle (intramuscular [IM]). The olanzapine IM preparation is only for acute agitation associated with schizophrenia and bipolar I mania in adults.

Olanzapine may work by blocking certain receptors in the brain, notably dopamine and serotonin, although the exact way it works in schizophrenia and bipolar I disorder is unknown.

Olanzapine was FDA approved on September 30, 1996, under the brand name Zyprexa. Generic olanzapine is available.

Olanzapine side effects

Olanzapine may cause serious side effects such as an increased risk of death or stroke in elderly patients with dementia, a higher risk of suicide when taken with fluoxetine, metabolic changes, tardive dyskinesia, low blood pressure, and blood cell disorders. See the warnings below for a full list of serious side effects.

Common side effects of olanzapine that affect 5% or more people who take it include postural hypotension (a drop in blood pressure when going from a lying or sitting position to standing)

• Constipation
• Weight gain and increased appetite
• Dizziness
• Personality disorder
• Restlessness
• Sedation
• Headache
• Abdominal pain
• Pain in the extremities
• Tiredness or lack of energy
• Dry mouth
• Tremor.

Other side effects may include increased salivation, speech disorder, forgetfulness, and the feeling of pins and needles in your limbs.

Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness when compared with adults.

Serious side effects and warnings

Olanzapine carries a Boxed warning for an increased risk of death in elderly patients with dementia-related psychosis.

An increased risk of death, strokes, or “mini-strokes” called transient ischemic attacks (TIAs) have been reported in elderly people taking olanzapine who are confused, have memory loss, or have lost touch with reality (dementia-related psychosis). These people should not be given olanzapine.

Olanzapine may cause the following serious side effects.

A higher risk of suicide when olanzapine is used in combination with fluoxetine for people with depression.

High blood sugar (hyperglycemia). This can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to a build-up of acid in your blood due to ketones (ketoacidosis), coma, and death. Your doctor should do tests to check your blood sugar before you start taking olanzapine and during treatment. Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused or your breath smells fruity.

High-fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers aged 13 to 17 or when used in combination with fluoxetine in children aged 10 to 17. Your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine and during treatment.

Weight gain. This is very common in people who take olanzapine, especially in teenagers aged 13 to 17, or when used in combination with fluoxetine in children aged 10 to 17. Some people gain a lot of weight. You and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Neuroleptic Malignant Syndrome (NMS). This is a rare but serious side effect of antipsychotics, such as olanzapine that may be fatal. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have symptoms such as high fever, excessive sweating, rigid muscles, confusion, changes in your breathing, heartbeat, and blood pressure.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This is a serious drug hypersensitivity syndrome with symptoms such as an extensive rash, fever, swollen lymph nodes, liver inflammation, and blood abnormalities. Tell your doctor immediately if you experience any of these signs.

Tardive Dyskinesia.This condition causes persistent body movements that usually affect the face and tongue which you cannot control. It may not go away even if you stop taking olanzapine and may start after you stop taking olanzapine. Tell your doctor if you get any body movements that you cannot control.

Decreased blood pressure when you go from a lying or sitting position to standing. Symptoms may include dizziness, fast or slow heartbeat, or fainting.

Difficulty swallowing, which may cause food or liquid to get stuck in your lungs

Seizures. Tell your doctor if you have had a seizure before or if you have one during treatment with olanzapine

Changes in your blood cells. Your doctor will monitor your blood cell counts especially if you have a history of significantly low white blood cell counts or drug-induced leukopenia or neutropenia

Problems with control of body temperature. You could become very hot, for instance when you exercise a lot or live or holiday in a very hot area. You need to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, or not able to produce enough urine.

May cause drowsiness and impair judgment, thinking, and motor skills. Use with caution when driving or operating machinery until you know how olanzapine affects you.

Olanzapine has not been approved for use in:

• children under 13 years of age when used to treat schizophrenia or bipolar I disorder
• children under 10 years of age when used in combination with fluoxetine for depressive episodes.

Tell your doctor about any side effect that bothers you or does not go away. These are not all the possible side effects of olanzapine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Olanzapine cost

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of olanzapine.

Before taking

Olanzapine may not be right for you. Before starting, tell your doctor if you have or had:

• heart problems
• seizures
• diabetes or high blood sugar levels (hyperglycemia)
• high cholesterol or triglyceride levels in your blood
• liver problems
• low or high blood pressure
• strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
• Alzheimer’s disease
• narrow-angle glaucoma
• enlarged prostate in men
• bowel obstruction
• phenylketonuria, because some olanzapine disintegrating tablets may contain phenylalanine.
• breast cancer
• thoughts of suicide or hurting yourself
• any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Tell your doctor if you exercise a lot or live or holiday in hot places.

Pregnancy

Taking antipsychotic medication, such as olanzapine, in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away but do not stop taking olanzapine without your doctor’s advice.

Talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/

Breastfeeding

Olanzapine passes into your breast milk. If you are breastfeeding, tell your doctor if you notice severe drowsiness, irritability, feeding problems, tremors, or unusual muscle movements in the nursing baby. Talk to your doctor about the best way to feed your baby if you take olanzapine.

How should I take olanzapine?

Take olanzapine exactly as prescribed. Your doctor may need to change (adjust) the dosage of olanzapine until it is right for you.

• Olanzapine is usually taken once a day.
• Olanzapine can be taken with or without food.

The usual starting dosage of olanzapine for adults with:

• Schizophrenia is olanzapine 5 mg to 10 mg once a day.
• Bipolar I disorder is olanzapine 10 mg to 15 mg once a day.

Olanzapine disintegrating tablets

Olanzapine disintegrating tablets dissolve in your mouth without water.

• Before taking it, make sure that your hands are dry.
• Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
• When you open the blister, remove the tablet and put it into your mouth.
• The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.

Olanzapine IM injection

Olanzapine IM is a short-acting formulation that may be given to adults with schizophrenia or bipolar I mania if they have become agitated.

• The usual dosage of olanzapine IM is 10 mg as a single dose.
  • Smaller dosages (5 mg or 7.5 mg) can be given if these are more appropriate.
• A maximum of 3 doses may be given if needed, 2 to 4 hours apart.
• Your doctor will monitor you for low blood pressure on standing (orthostatic hypotension) before giving you another dose. Tell your doctor if you feel faint or dizzy when you stand up.

Olanzapine: other information

You may need regular medical tests while taking olanzapine to check your cholesterol levels.

If you are diabetic, check your blood sugar levels regularly, because olanzapine can cause high blood sugar levels, even in people who are not diabetic.

Olanzapine may cause you to gain weight more easily. Be conscious of your weight and what you eat. Exercise regularly. Talk to your healthcare provider if you are putting on too much weight.

Call your healthcare provider if you do not think you are getting better or have any concerns about your condition while taking olanzapine.

• The symptoms of bipolar I disorder, treatment-resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.

What should I avoid while taking olanzapine?

Olanzapine can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how it affects you.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid getting up too fast from sitting or lying down, or you may feel dizzy.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking olanzapine.

Avoid stopping olanzapine suddenly. You should never stop taking it without your doctor’s advice. When it comes time to stop olanzapine, it should be withdrawn slowly over several weeks under a doctor’s supervision. One survey reported at least 72% of people taking antipsychotics such as olanzapine experienced withdrawal symptoms.

Olanzapine withdrawal

Common symptoms of olanzapine withdrawal include nausea, headaches, dizziness, sleep disturbances, brain zaps, and psychological symptoms, such as anxiety, irritability, mood swings, and difficulty concentrating.

• Nearly half of people describe these symptoms as severe, especially during the early stage of withdrawal.
• The length of time withdrawal symptoms from olanzapine last varies; some report symptoms last two weeks or less, while others experience symptoms for years. This appears to correlate with the length of time people have taken the medication.
• If you want to stop taking olanzapine, talk to your healthcare provider about the best way to come off it. This may involve slowly reducing your dose, switching to another medication that might be easier to withdraw from, or taking other medications to help with your withdrawal symptoms.

What happens if I miss a dose?

If you miss a dose of olanzapine, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

What happens if I overdose?

If you take too much olanzapine, call your doctor or poison control center right away, or get emergency treatment.

Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.

What other drugs will affect olanzapine?

Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Olanzapine and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take olanzapine with your other medicines. Do not start or stop any medicine while taking olanzapine without talking to your doctor first. Especially tell your doctor if you take:

• Diazepam, lorazepam, or other benzodiazepines. This may make some side effects such as orthostatic hypotension worse
• Carbamazepine. May reduce the effect of olanzapine.
• Fluvoxamine. May increase levels of olanzapine and make side effects worse
• Fluoxetine. This may increase the risk of suicidal thoughts and behaviors
• Other medications that affect the brain, such as sedatives or sedating antihistamines. These can make side effects worse, especially when combined with alcohol
• Heart medications that lower blood pressure. Olanzapine may cause an enhanced effect
• Levodopa and dopamine Agonists. Olanzapine may counteract the effects of these drugs.

Anticholinergics (antimuscarinics), such as benztropine. Use with caution in patients with urinary retention, prostatic conditions, constipation, and some other conditions

Alcohol may also make side effects such as sleepiness and orthostatic hypotension worse.

Taking olanzapine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

This is not a complete list of interactions. Talk to your healthcare provider or pharmacist for a full list of interactions.

Storage

Store olanzapine at room temperature, between 68°F to 77°F (20°C to 25°C), away from light. Keep it dry and away from moisture.

Keep out of the reach of children.

Olanzapine ingredients

Active: olanzapine.

Inactive: Depends on the manufacturer. Various generic manufacturers make olanzapine, such as Apotex Inc., Dr Reddys Labs Ltd, and Zydus Pharms. Eli Lilly and Company makes the brand of olanzapine called Zyprexa.

Olanzapine tablets (brand Zyprexa)

Active ingredient: olanzapine.

Inactive ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients.

Color coating: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.

Olanzapine is available as olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg tablets. Tablets are not scored.

Olanzapine disintegrating tablets ingredients (brand Zyprexa Zydis)

Active ingredient: olanzapine.

Inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propylparaben.

Olanzapine Zydis orally disintegrating tablets are available as olanzapine 5 mg, 10 mg, 15 mg, and 20 mg tablets. Tablets are not scored.

Olanzapine IM injection ingredients (brand Zyprexa)

Active ingredient: olanzapine.

Inactive ingredients: lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide.

Olanzapine injection is available as an olanzapine 10 mg vial.

Who makes olanzapine?

Various generic manufacturers make olanzapine, such as Apotex Inc., Dr Reddys Labs Ltd, and Zydus Pharms.

Eli Lilly and Company makes the brand of olanzapine called Zyprexa.

Introduction

Relatively selective histamine H₁-receptor antagonist and mast-cell stabilizer.

Uses for Olopatadine

Allergic Conjunctivitis

Used ophthalmically for symptomatic management of ocular itching associated with allergic conjunctivitis.

Seasonal Allergic Rhinitis

Used intranasally to provide symptomatic relief of seasonal allergic rhinitis (e.g., hay fever).

Provides symptomatic relief of nasal congestion, rhinorrhea, nasal itching, and sneezing.

Olopatadine Dosage and Administration

Administration

Administer intranasally or topically to the eye.

Intranasal Administration

Administer intranasally twice daily, using a metered-dose nasal spray pump. Avoid spraying into the eyes.

Before initial use, prime the pump by releasing 5 sprays or until a fine mist appears. If nasal spray has not been used for >7 days, reprime the pump by releasing 2 sprays.

To actuate the pump, hold the bottle in one hand; with forefinger and middle finger on the shoulders of the pump unit and the thumb on the bottom of the bottle, press down on the shoulders of the pump to produce a fine mist.

Prior to administration, gently blow the nose to clear nasal passages. To administer, close one nostril; then, with head tipped down (chin toward chest), insert nasal applicator ¼ to ½ inch into the other nostril, hold bottle vertically upright, and aim spray tip toward the cheek side of the nose (away from the center of the nose). While gently breathing in through the nose, press firmly and quickly on the pump to release the spray. Breathe out through the mouth.

Do not tip head back or blow the nose immediately after dosing; tipping head back may produce a bitter taste in the mouth.

Repeat procedure for the other nostril. Alternate nostrils between each actuation.

Following administration, wipe nasal applicator with a clean tissue and replace the blue plastic cap.

If nasal applicator becomes clogged, do not attempt to clean by inserting a sharp object. Instead, remove nasal applicator by gently pulling it upward; once removed, wash (while pointing nasal applicator downward) by running warm tap water for about one minute. Shake the applicator to remove any water and place the applicator back on the bottle. Prime by spraying 2 times or until a fine mist appears.

Discard after 240 sprays.

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution. Not for injection or oral use.

If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.

Avoid contamination of the solution container.

Dosage

Available as olopatadine hydrochloride; dosage expressed in terms of olopatadine.

Nasal spray delivers about 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg of olopatadine) per metered spray and about 240 metered sprays per 30.5-g bottle.

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

0.1% ophthalmic solution: In children ≥3 years of age, 1 drop in the affected eye(s) twice daily (at an interval of 6–8 hours).

0.2% ophthalmic solution: In children ≥2 years of age, 1 drop in the affected eye(s) once daily.

Once symptomatic improvement is established, continue therapy for as long as necessary to sustain improvement.

Seasonal Allergic Rhinitis

Intranasal

Children 6–11 years of age: 1 spray (600 mcg) in each nostril twice daily.

Children ≥12 years of age: 2 sprays (1200 mcg) in each nostril twice daily.

Adults

Allergic Conjunctivitis

Ophthalmic

0.1% ophthalmic solution: 1 drop in the affected eye(s) twice daily (at an interval of 6–8 hours).

0.2% ophthalmic solution: 1 drop in the affected eye(s) once daily.

Once symptomatic improvement is established, continue therapy for as long as necessary to sustain improvement.

Seasonal Allergic Rhinitis

Intranasal

2 sprays (1200 mcg) in each nostril twice daily.

Special Populations

Hepatic Impairment

Nasal spray: Dosage adjustment not necessary.

Hepatic Impairment

Nasal spray: Dosage adjustment not necessary.

Geriatric Patients

Nasal spray: Select dosage with caution. (See Geriatric Use under Cautions.)

Cautions for Olopatadine

Contraindications

• Ophthalmic solution: Known hypersensitivity to olopatadine or any ingredient in the formulation.Nasal spray: Manufacturer states none known.

Warnings/Precautions

Proper Handling to Avoid Contamination of Ophthalmic Solution

To avoid contamination of the dropper tip and solution, do not to touch the eye, eyelids, or surrounding areas with the dropper tip. Close container tightly when not in use.

Contact Lenses

Ophthalmic solution not indicated for contact lens-related ocular irritation. Do not wear contact lenses if eyes are red.

Remove soft contact lenses prior to administration of each ophthalmic dose, since benzalkonium chloride preservative may be absorbed by soft contact lenses; lenses may be reinserted after ≥10 minutes following administration.

Nasal Effects

Epistaxis, nasal ulcerations, and nasal septal perforations reported with nasal spray. Perform nasal examination prior to initiating intranasal olopatadine therapy to ensure absence of nasal diseases (other than allergic rhinitis). Perform nasal examinations periodically for signs of adverse effects on the nasal mucosa. If nasal ulcerations occur, consider discontinuing nasal spray.

CNS Effects

Somnolence reported with nasal spray. Avoid engaging in activities requiring complete mental alertness and motor coordination (e.g., driving or operating machinery) after administration of nasal spray. Concomitant use of nasal spray with alcohol or other CNS depressants may result in additive CNS depression; therefore, avoid such concomitant use.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats following oral administration.

Ophthalmic solution: Not known whether distributed into human milk following topical application to the eye. Use with caution.

Nasal spray: Use only if potential benefits outweigh risks.

Pediatric Use

0.1% ophthalmic solution: Safety and efficacy not established in children <3 years of age. Appears to be well-tolerated in children 3–16 years of age.

0.2% ophthalmic solution : Safety and efficacy not established in children <2 years of age.

Nasal spray: Safety and efficacy not established in children <6 years of age. In clinical studies, incidence of epistaxis was higher in children 6–11 years of age (5.7%) compared with adolescents or adults (3.2%).

Geriatric Use

Ophthalmic solution: No substantial differences in safety and efficacy relative to younger adults.

Nasal spray: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Other clinical experience has not identified differences in responses between geriatric and younger patients. Select dosage with caution because of age-related decreases in hepatic, renal, or cardiac function and potential for concomitant disease and drug therapy.

Common Adverse Effects

0.1% ophthalmic solution: Headache.

0.2% ophthalmic solution: Symptoms similar to cold syndrome, pharyngitis.

Nasal spray: In adults and children ≥12 years of age, bitter taste, headache, epistaxis, pharyngolaryngeal pain, postnasal drip, cough, urinary tract infection. In children 6–11 years of age, epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, rash.

Drug Interactions

No formal drug interaction studies involving ophthalmic solution or nasal spray to date.

Does not inhibit in vitro metabolism of substrates of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4.

Drugs Affecting or Metabolized by Hepatic Enzymes

Interactions with drugs that inhibit hepatic enzymes (e.g., CYP microsomal enzymes) unlikely because olopatadine is eliminated predominantly by renal excretion.

Potential for olopatadine and its metabolites to act as inducers of CYP isoenzymes not evaluated.

Protein-bound Drugs

Interactions with protein-bound drugs (e.g., possible displacement of other protein-bound drugs) unlikely because olopatadine is modestly protein bound.

Specific Drugs

Olopatadine Pharmacokinetics

Absorption

Bioavailability

Ophthalmic solution: Limited systemic exposure following topical application to the eye; plasma concentrations usually are undetectable.

Nasal solution: Peak plasma concentrations observed between 15 minutes and 2 hours following twice-daily intranasal administration. Average absolute bioavailability in healthy individuals is 57%.

Onset

Ophthalmic solution: Rapid onset; symptomatic relief of itching generally occurs within 30 minutes.

Nasal spray: Onset of action occurs after one day.

Duration

0.1% ophthalmic solution: Long duration (≥8 hours).

Special Populations

Nasal spray: Mean peak plasma concentrations following single intranasal doses not markedly different between healthy individuals and patients with mild, moderate, or severe renal impairment.

Distribution

Extent

Distribution into human ocular tissues and fluids not characterized.

Plasma Protein Binding

Approximately 55% bound (mainly albumin).

Elimination

Metabolism

Not extensively metabolized.

Following oral administration, unchanged olopatadine accounts for 77% of peak plasma total radioactivity, while metabolites (e.g., olopatadine N-oxide, N-desmethyl olopatadine) account for <6%.

Elimination Route

Eliminated principally by renal excretion; about 60–70% of systemically absorbed dose excreted in urine (86% as unchanged olopatadine) , and about 17% excreted in feces.

Half-life

Approximately 3 hours following topical application to the eyes.

8–12 hours following oral administration.

Stability

Storage

Nasal

Solution

4–25°C.

Ophthalmic

Solution

2–25°C.

Actions

• Inhibits type I immediate hypersensitivity reactions in vitro and in vivo.
• Suppresses the release of inflammatory mediators (e.g., histamine, prostaglandin D₂, tryptase) in response to antigenic stimulation of human conjunctival mast cells in a dose-dependent manner.
• Decreases chemotaxis and inhibits eosinophil activation.
• Inhibits histamine-stimulated conjunctival vascular permeability response in a concentration-dependent manner.
• Potency is comparable to that of levocabastine and exceeds that of pheniramine or antazoline.

• Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution container.
• Importance of learning and adhering to proper techniques for priming and administration of nasal spray. Importance of alternating nostrils between each actuation. Importance of avoiding spraying into eyes.
• With ophthalmic solution, importance of removing soft contact lenses prior to administration of each dose. Delay reinsertion for ≥10 minutes after administration if eyes are not red; do not wear contact lenses if eye(s) are red. Not indicated for contact lens-related irritation.
• With ophthalmic solution, importance of administering different topical ophthalmic preparations at least 5 minutes apart.
• With nasal spray, risk of epistaxis and nasal ulcerations.
• With nasal spray, risk of somnolence. Avoid engaging in activities requiring complete mental alertness and motor coordination (e.g., driving or operating machinery) after administration. Avoid concomitant use with alcohol or other CNS depressants.
• Importance of patients informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

What is olopatadine nasal?

Olopatadine nasal (for the nose) is used to treat seasonal allergy symptoms such as congestion, sneezing, and runny nose.

Olopatadine nasal is for use in adults and children at least 6 years old.

Olopatadine nasal may also be used for purposes not listed in this medication guide.

Olopatadine nasal side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Olopatadine may cause serious side effects. Stop using olopatadine and call your doctor at once if you have:

• nosebleed;
• painful sores inside your nose;
• fever; or
• pain or burning when you urinate.

Common side effects of olopatadine may include:

• runny or stuffy nose, nosebleeds;
• cough, throat pain or irritation;
• a bitter taste in your mouth;
• drowsiness;
• headache;
• fever;
• rash; or
• painful urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use olopatadine if you are allergic to olopatadine.

Tell your doctor if you have other conditions that affect the inside of your nose.

Tell your doctor if you are pregnant or breastfeeding.

Not approved for use by anyone younger than 6 years old.

How should I use olopatadine nasal?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before your first use, shake the nasal spray well and prime it with 5 sprays into the air, until a fine mist appears. Spray away from your face. Prime again with 2 sprays whenever the medicine has not been used in longer than 7 days.

Gently blow your nose before using the nasal spray.

Carefully follow all Instructions for Use provided with this medicine.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Throw away the bottle after 240 sprays have been used, even if there is still medicine left inside. If used daily, one bottle contains enough medicine for 30 days for an adult dose or 60 days for a child’s dose.

Olopatadine dosing information

Usual Adult Dose for Allergic Rhinitis:

2 sprays in each nostril twice a day

Use: For the relief of symptoms of seasonal allergic rhinitis

Usual Pediatric Dose for Allergic Rhinitis:

6 to 11 years: 1 spray in each nostril twice a day

12 years or older: 2 sprays in each nostril twice a day

Use: For the relief of symptoms of seasonal allergic rhinitis

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include feeling agitated or restless and then drowsy.

What should I avoid while taking olopatadine nasal?

Avoid driving or hazardous activity until you know how olopatadine will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can cause side effects.

Avoid getting this medication in your eyes.

What is olopatadine ophthalmic?

Olopatadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of itching or watery eyes.

Olopatadine ophthalmic (for the eye) is used to treat eye itching caused by allergies.

Olopatadine ophthalmic may also be used for purposes not listed in this medication guide.

Olopatadine ophthalmic side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

olopatadine ophthalmic may cause serious side effects. Stop using olopatadine ophthalmic and call your doctor at once if you have:

• eye pain or changes in vision;
• eye itching that gets worse or lasts longer than 72 hours;
• severe burning, stinging, or irritation after using this medicine; or
• eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection).

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use olopatadine ophthalmic if you are allergic to it.

Ask a doctor or pharmacist if olopatadine ophthalmic is safe to use if you have any type of eye infection.

Tell your doctor if you are pregnant or breastfeeding.

Olopatadine ophthalmic is not approved for use by anyone younger than 2 years old.

How should I use olopatadine ophthalmic?

Use exactly as directed on the label, or as prescribed by your doctor.

Do not use while wearing soft contact lenses. A preservative in this medicine could permanently stain the lenses. Use the medicine at least 15 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

To apply the eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Use only the number of drops recommended on the medicine label.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid looks cloudy or has changed colors.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Olopatadine ophthalmic dosing information

Usual Adult Dose for Seasonal Allergic Conjunctivitis:

0.1% solution: 1 drop in each affected eye twice per day at an interval of 6 to 8 hours
0.2%/0.7% solution: 1 drop in each affected eye once a day

Use: Treatment of the signs and symptoms of allergic conjunctivitis

Usual Pediatric Dose for Seasonal Allergic Conjunctivitis:

2 years or older:
0.2%/0.7% solution: 1 drop in each affected eye once a day

3 years or older:
0.1% solution: 1 drop in each affected eye twice per day at an interval of 6 to 8 hours

Use: Treatment of the signs and symptoms of allergic conjunctivitis

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

An overdose of olopatadine ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using olopatadine ophthalmic?

Avoid wearing contact lenses while your eyes are red or irritated. olopatadine ophthalmic will not treat eye irritation caused by wearing contacts.

What is Olux?

Clobetasol is a highly potent steroid that helps reduce inflammation in the body.

Olux (for the skin) is used to treat inflammation and itching caused by plaque psoriasis or skin conditions that respond to steroid medication.

Olux may also be used for purposes not listed in this medication guide.

Olux side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Olux may cause serious side effects. Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing Olux through your skin–weight gain in your face and shoulders, slow wound healing, skin discoloration, thinning skin, increased body hair, tiredness, mood changes, menstrual changes, sexual changes.

Common side effects of Olux may include:

• burning, itching, swelling, or irritation of treated skin;
• dry or cracking skin;
• redness or crusting around your hair follicles;
• spider veins;
• stretch marks, thinning skin;
• rash or hives;
• acne; or
• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Olux if you are allergic to it.

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder.

Steroid medicines can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

It is not known whether Olux will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you apply clobetasol to your chest, avoid areas that may come into contact with the baby’s mouth.

Olux is not approved for use by anyone younger than 12 years old. Some brands or forms of this medicine are for use only in adults 18 and over.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

How should I use Olux?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin. Rinse with water if this medicine gets in your eyes or mouth.

Do not use Olux on broken or infected skin. Also avoid using this medicine in open wounds.

Wash your hands before and after using clobetasol, unless you are using the medicine to treat the skin on your hands.

Apply a thin layer of medicine to the affected skin and rub it in gently. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

If you are treating the diaper area, do not use plastic pants or tight-fitting diapers.

This medicine is for short-term use only (2 weeks, or up to 4 weeks for scalp psoriasis). Follow your doctor’s dosing instructions very carefully.

If you use clobetasol to treat plaque psoriasis, you should stop using the medicine once your skin symptoms are controlled.

Call your doctor if your symptoms do not improve, or if they get worse.

You should not stop using clobetasol suddenly. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep from freezing.

Clobetasol foam is flammable. Do not use near high heat or open flame. Do not smoke until the foam has completely dried on your skin.

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

High doses or long-term use of Olux can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using clobetasol topical?

Avoid applying Olux to your face, underarms, or groin area.

Do not use this medicine to treat any condition that has not been checked by your doctor.

Avoid using other topical steroid medications on the areas you treat with clobetasol unless your doctor tells you to.

What is omalizumab?

Omalizumab (Xolair) injection is used to reduce the risk of severe food allergy reactions (anaphylaxis) and help improve allergic asthma, nasal polyps, and chronic hives symptoms. Omalizumab works by targeting specific proteins in the immune system to reduce allergy symptoms.

Omalizumab is given as an injection under the skin every 2 to 4 weeks and can be self-injected using a pen (autoinjector) or a prefilled syringe.

Omalizumab is an anti-IgE antibody that works by blocking a protein (IgE ) that plays a key role in allergic responses. Omalizumab is a preventative medicine that reduces symptoms caused by allergies; it does not treat acute asthma or emergency allergic reactions, including anaphylaxis.

Omalizumab FDA approval was granted on June 20, 2003, for Genentech and Novartis Pharmaceuticals.

Omalizumab brand name is Xolair.

What is omalizumab used for?

Omalizumab is used to treat:

• food allergies to reduce allergic reactions including anaphylaxis after accidentally eating food you are allergic to. Omalizumab can be used for IgE-mediated food allergy in adults and children aged 1 year and older. May be given repeatedly and should be used in conjunction with food allergen avoidance. It should not be used for the emergency treatment of allergic reactions, including anaphylaxis.
• moderate to severe asthma that is caused by allergies for adults and children who are at least 6 years old. It can be used if asthma symptoms are not controlled by asthma-inhaled steroid medicine. It is not a rescue medicine for treating an asthma attack.
• chronic hives with no known cause (chronic spontaneous urticaria) in adults and children who are at least 12 years old. It can should only be used if antihistamine medicines have been tried but were not successful. It should not be used for other forms of hives.
• nasal polyps in people 18 years of age and older as an add-on medicine if medicines called nasal corticosteroids have not worked well

How does omalizumab work?

If you have allergies, your overactive immune system produces antibodies called Immunoglobulin E (IgE) which bind to receptors on cells in the immune system (mast cells). When you are exposed to the allergen (food, dust, grass) the allergen binds to IgE on the cells which sets off an allergic reaction triggering the release of chemicals like histamine, which causes the allergic reaction.

Omalizumab mechanism of action is by blocking the binding of IgE to receptors on cells, which in turn stops the release of the chemicals responsible for allergy symptoms. Omalizumab also reduces the number of IgE receptors on cells, resulting in further improvement of allergy symptoms.

Omalizumab side effects

Common omalizumab side effects

Common omalizumab side effects include: 

• fever;
• rash;
• nausea, vomiting, diarrhea, stomach pain;
• Itching or a skin rash;
• headache;
• dizziness; 
• joint pain usually in arms or legs, bone fractures;
• ear pain, ear infection;
• Swelling in sinuses, nose or throat;
• Throat infection
• nose bleeds
• injection site reaction with pain, bruising, swelling, or irritation where the medicine was injected; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, cough, sore throat.

The common omalizumab side effects vary depending on the condition being treated and the age group of the patient. 

Serious omalizumab side effects

Some people using omalizumab have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to omalizumab:

• hives, itching;
• anxiety or fear, feeling like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• chest tightness, wheezing, cough, feeling short of breath, difficult breathing;
• fast or weak heartbeats; or
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• ongoing nausea or vomiting, severe or watery diarrhea;
• trouble breathing;
• numbness or tingling in your arms or legs;
• fever, muscle pain, and rash within a few days after receiving an injection;
• signs of an ear infection – fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Some people using this injection have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using this injection regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to omalizumab: hives, rash; anxiety or fear; flushing (warmth, redness, or tingly feeling); feeling like you might pass out; chest tightness, wheezing, feeling short of breath, difficult breathing; fast or weak heartbeats; swelling of your face, lips, tongue, or throat.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the injection as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Omalizumab should not be used for the emergency treatment of allergic reactions, including anaphylaxis. It is only used in food allergy to reduce the risk of allergic reactions.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Before taking this medicine

You should not use this medicine if you are allergic to omalizumab, or any of the inactive ingredients.  See the bottom of this document for a full list of ingredients. To make sure omalizumab is safe for you, tell your doctor if you have:

• any signs of infection (fever, swollen glands, general ill feeling)
• any other allergies (foods, pollens, etc.)
• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others)
• past or present cancer
• a history of heart attack or stroke
• if you are receiving allergy shots
• if you have ever had a severe allergic reaction (anaphylaxis)
• if you have a latex allergy, as the needle cap on the prefilled syringe contains a type of natural rubber latex.

Using this injection may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using this medicine, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant during treatment.   If you become pregnant while using this injection, call your doctor.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of omalizumab on the baby.

Breastfeeding 

It is not known whether omalizumab could harm a nursing baby. Tell your doctor if you are breastfeeding or planning to breastfeed a baby..

How should I use omalizumab?

Before you start treatment with this medicine, your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

Omalizumabis given as an injection under the skin (subcutaneous injection). When you first start your treatment, the injection will be given to you by your healthcare provider. 

You will be watched closely for a short time after receiving the injection to make sure you do not have an allergic reaction to the medication.

Your healthcare provider may decide that the injections can be administered by you or a caregiver, and you will receive training on the right way to prepare and inject this medicine. Do not try to inject omalizumab until you have been shown the right way to use the prefilled syringe injections.

For children 12 years of age and older, the prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, the prefilled syringe should be injected by a caregiver.

Omalizumab is usually given every 2 or 4 weeks, depending on what condition you are treating.

Your condition may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

If you also use a steroid medicine, do not stop using it suddenly, or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

While using this medicine, you may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

Your condition may not improve right away. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Omalizumab Prefilled Syringe instructions:

• Take the carton containing the prefilled syringe out of the refrigerator. Set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. Leave the prefilled syringe in the carton to protect it from light.
• Do not speed up the warming process using any heat sources such as warm water or a microwave.
• Check the contents of the prefilled syringe for particulate matter and discoloration prior to administration. The solution should be clear and colorless to pale brownish yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles.
• Check the number of prefilled syringes needed for the patient’s dosage.
• For patients requiring more than 1 injection to complete a full dose, administer each injection at least 1 inch apart from other injection sites.
• Use the injection within 4 hours after taking it out of the refrigerator
• Administer subcutaneous injection into the thigh or abdomen, avoiding the 2-inch (5 cm) area directly around the navel. The outer area of the upper arms may be used only if the injection is being given by a caregiver or healthcare provider. The injection may take 5-10 seconds to administer.
• Dispose of the used syringe in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Omalizumab dosing information

Usual omalizumab dose for food allergy (IgE-Mediated):

Dose: 75 mg to 600 mg subcutaneously every 2 or 4 weeks.

• Determine the dosage and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and the person’s body weight (kg).
• See the dose determination chart in the prescribing information.

Usual adult and pediatric dose for asthma:

Dose: 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks. Dose and frequency of injection is based on weight and pre-treatment IgE levels. 

Comments: 

• Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
• Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
• Periodically reassess the need for continued therapy based on the patient’s disease severity and level of asthma control.

Use: Management of moderate to severe persistent asthma in patients  (12 Years and Older) who are inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen.

Usual Adult Dose for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Dose: 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks. The dose and frequency of injection are based on weight and pre-treatment IgE levels. Click on the link below “Detailed Xolair dosage information” for dose details.

Comments:

• Periodically reassess the need for continued therapy based upon the patient’s disease severity and level of symptom control.
• Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
• Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.

Use: As an add-on maintenance treatment for Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Usual Adult Dose for Chronic Spontaneous Urticaria (CSU):

Dose: 150mg or 300 mg subcutaneously every 4 weeks.

Comments:

• Dosing is not dependent on IgE levels or body weight.
• Avoid administering more than 150 mg per injection site.
• The appropriate duration of therapy for CSU has not been evaluated. Periodically reassess the need for continued therapy.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment.. 

Xolair formulations

Xolair Autoinjector (single-dose prefilled): 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL

Prefilled syringe (single-dose): 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL

Single-dose vial for reconstitution: 150 mg lyophilized powder

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect omalizumab?

Other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.
It is important to tell your doctor or healthcare provider if you have any of the following: allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances) and medications that suppress your immune system. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

This list is not complete. Many other drugs may interact with Xolair, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Storage

• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep your unused prefilled syringes in the original carton until use to protect them from light.
• The Xolair prefilled syringe can be removed and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 2 days. 
• Do not use the prefilled syringe if it is exposed to temperatures above 77°F (25°C) and discard it in a sharps disposal container.
• Do not freeze. Do not use if prefilled syringes have been frozen.
• Keep this medicine out of direct sunlight.
• Do not use this medicine if it is past the expiration date.

Ingredients 

Active ingredient: omalizumab

Inactive ingredients:

Xolair Prefilled syringe or autoinjector: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20.

Xolair Vial: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose.

Manufacturer

Manufactured by:

• Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. U.S. License No.: 1048.

Jointly marketed by:

• Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.
• Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080.

Omalizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for omalizumab.Xolair (omalizumab) – Genentech, Inc.

What is Omega-3?

Certain prescription Omega-3 are used in adults, together with diet to help lower triglyceride levels in the blood.

Omega-3 may also be used in combination with other vitamins in adults and children as a dietary supplement.

Omega-3 may also be used for purposes not listed in this medication guide.

Omega-3 side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Omega-3 may cause serious side effects. Call your doctor at once if you have:

• chest pain; or
• uneven heartbeats.

Common side effects of Omega-3 may include:

• burping, changes in your sense of taste;
• loss of appetite;
• diarrhea, constipation, upset stomach;
• back pain; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed and follow all directions on the label and package. Tell each of your healthcare providers if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use Omega-3 if you are allergic to Omega-3, soy, fish or shellfish.

Ask your doctor or pharmacist before taking Omega-3 if you have any health problems.

Tell your doctor if you have or have ever had:

• diabetes;
• bleeding problems, anemia (low red blood cells);
• a heart rhythm disorder;
• a pancreas disorder;
• underactive thyroid; or
• liver disease.

It is not known if Omega-3 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Omega-3.

Do not give any herbal or health supplement to a child without medical advice.

How should I take Omega-3?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use more of this product than is recommended on the label.

The recommended daily dose of omega-3 polyunsaturated fatty acids changes with age. Follow your healthcare provider’s instructions. You may also consult the Office of Dietary Supplements of the NIH, or the USDA Nutrient Database of recommended daily allowances for more information.

Over the counter (OTC) products should not be used to replace medication prescribed for you by your doctor. Ask your doctor, pharmacist, or other healthcare provider if it is safe to use this product.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You must chew the chewable tablet before you swallow it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Your treatment may also include diet, exercise, weight control, and blood tests.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Omega-3?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Avoid using Omega-3 together with other herbal/health supplements that can also affect blood-clotting. This includes angelica (dong quai), capsicum, clove, dandelion, danshen, evening primrose, garlic, ginger, ginkgo, horse chestnut, Panax ginseng, poplar, red clover, saw palmetto, turmeric, and willow.

What other drugs will affect Omega-3?

Do not take Omega-3 without medical advice if you are using any of the following medications:

• medicine used to prevent blood clots–alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• a blood thinner–warfarin, Coumadin, Jantoven, apixaban, rivaroxaban, dabigatran.

What is Orencia?

Orencia (abatacept) is a type of biologic that is given by intravenous infusion or subcutaneous (under the skin) injection which helps prevent your body’s immune system from attacking healthy joints and other tissues and is approved for:

• adults with moderately to severely active rheumatoid arthritis
• patients aged 2 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis
• patients aged 2 years and older with active psoriatic arthritis
• the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and children aged 2 years and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

Orencia works by helping to block T-cell activation in the immune system and belongs to the class of medicines known as selective T-cell costimulation modulators. Blocking T-cell activation interrupts the cycle that can lead to joint inflammation, pain, and destruction in certain forms of arthritis and acute graft versus host disease. T-cells are part of the immune system that helps to protect you from certain infections and cancers. It is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Orencia was first FDA-approved on 23 December 2005.

Warnings

Hypersensitivity reactions, including anaphylaxis, have occurred.

Orencia carries a risk of serious infections. People with a history of recurrent infections or with underlying conditions that predispose them to infections (such as a weakened immune system, COPD, or diabetes) are more at risk. Using Orencia with a TNF antagonist can increase your infection risk.

Your doctor should screen you for viral hepatitis and latent TB infection before starting treatment with Orencia. If you test positive for TB your doctor will initiate TB treatment.

All your childhood vaccinations and other age-appropriate vaccinations should be up to date before starting Orencia. Live vaccines should not be given concurrently or within 3 months of discontinuation. Orencia may blunt the effectiveness of some immunizations.

The risk of respiratory side effects may be more common in patients with COPD (Chronic Obstructive Pulmonary Disease). There is a risk of cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) reactivation in patients treated for aGVHD prophylaxis.

It is not known if Orencia is safe and effective in children less than two years of age.

Before taking

You should not use Orencia if you are allergic to Orencia, abatacept, or any of the components of the intravenous or subcutaneous injection.

Before you receive or use Orencia, tell your healthcare provider about all of your medical conditions, including if you have:

• any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu)
• an infection that will not go away, an infection that keeps coming back, or inflammation of your liver due to an infection (viral hepatitis)
• had a lung infection called tuberculosis (TB), a positive skin test for TB, or you recently have been in close contact with someone who has had TB. Symptoms of TB may include:
  • a cough that does not go away
  • fever
  • weight loss
  • night sweats.
• a history of Epstein-Barr Virus (EBV) or Cytomegalovirus (CMV) if you are receiving Orencia for the preventative treatment of aGVHD during HSCT from an unrelated donor
• been scheduled to have surgery
• recently received a vaccination or are scheduled for a vaccination
• a history of a breathing problem called chronic obstructive pulmonary disease (COPD)
• have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Some people treated with Orencia have developed skin cancer. Tell your healthcare provider if you have a family or personal history of skin cancer, or if you see any growths or changes in the appearance of your skin during or after treatment.

Pregnancy and breastfeeding

It is not known if Orencia can harm an unborn baby. If you inadvertently become pregnant while taking Orencia, register with the pregnancy registry by calling 1-877-311-8972. When your baby is born talk to your healthcare provider before your baby receives any vaccines.

It is not known if Orencia passes into breast milk. Talk to your healthcare provider about the best way to feed your baby.

How will I receive Orencia?

Orencia is usually injected as an infusion into the vein initially, and, depending on your condition, it can be self-administered at home as an injection under the skin. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

For the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis

The first dose of Orencia may be given by a healthcare provider through a vein in your arm (intravenous infusion).

• The infusion takes about 30 minutes.
• The next dose will be 2 weeks later, then 4 weeks after the first dose, and then every 4 weeks thereafter.
• Intravenous administration of Orencia is not approved for pediatric patients with psoriatic arthritis. Orencia is injected under the skin when given to a child between 2 and 6 years old.

You may also receive Orencia as an injection under your skin (subcutaneous).

• For home use, Orencia comes in a prefilled syringe or a prefilled ClickJect autoinjector.
• If you want to self-administer Orencia your healthcare provider will train you or your caregiver on the right way to prepare and inject Orencia. Do not try to inject it until you have been shown the right way to do so.
• Your healthcare provider will advise you of the dose.

For the preventative treatment of aGVHD

Orencia is given by a healthcare provider through a vein in your arm over 60 minutes on the day before transplantation (Day 1).

• You will then receive ORENCIA on Days 5, 14, and 28 after transplantation.
• Your healthcare provider may give you antiviral medicines before, during, and after your transplantation to help prevent Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) infections.

What happens if I miss a dose?

Call your doctor for instructions if you miss your Orencia dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Orencia?

Do not receive a “live” vaccine while using Orencia, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the side effects of Orencia?

Get emergency medical help if you have signs of an allergic reaction to Orencia such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Orencia may cause serious side effects, including:

• infections which may be serious or fatal. Call your healthcare provider right away if you have any symptoms of an infection, such as:
  • fever
  • flu-like symptoms
  • feeling very tired
  • warm, red, or painful skin
  • a cough
  • pain, or burning when you urinate.
• hepatitis B infection in people who carry the virus in their blood. Your healthcare provider may do a blood test before you start treatment
• breathing problems in people with Chronic Obstructive Pulmonary Disease (COPD). You may get certain respiratory problems more often if you receive ORENCIA and have COPD. Symptoms of respiratory problems include COPD that becomes worse, difficulty breathing, or a cough
• cancer (malignancies). Certain kinds of cancer have been reported in people using Orencia, including skin cancers. It is not known if Orencia increases your chance of getting cancer
• Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) infections in people receiving preventative treatment of aGVHD during unrelated HSCT. Your healthcare provider will monitor you for 6 months after transplantation and may treat you with medicines to help prevent CMV and EBV infection if needed.

The most common side effects of Orencia include:

• headache
• sore throat
• upper respiratory tract infection
• nausea.

In children and adolescents, other side effects may include:

• diarrhea
• fever
• cough
• abdominal pain.

The most common side effects of Orencia in the prevention of aGVHD include:

• low red blood cell count
• nosebleeds
• high blood pressure
• decreased CD4 lymphocytes
• CMV infection
• increased levels of magnesium in the blood
• fever
• kidney problems
• pneumonia.

These are not all the possible side effects of Orencia. Call your doctor for medical advice about side effects.

What other drugs will affect Orencia?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orencia may affect the way other medicines work, and other medicines may affect the way it works causing serious side effects.

You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines that may affect your immune system. Especially tell your healthcare provider if you take other biologic medicines that may affect your immune system, such as:

• adalimumab
• anakinra
• certolizumab
• etanercept
• golimumab
• infliximab
• rituximab
• tocilizumab.

Orencia can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to test your blood sugar.

Orencia for intravenous infusion contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of the infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. Orencia for subcutaneous injection does not contain maltose.

This list is not complete. Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original package (protected from light). Do not freeze.

The prefilled syringe or autoinjector can be left out of the refrigerator for up to 6 hours (without light protection) if the temperature remains between 46°F to 77°F (8°C to 25°C).

Ingredients

Active: abatacept.

Intravenous, inactive: maltose, monobasic sodium phosphate, sodium chloride for administration.

Subcutaneous, inactive: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, water for injection.

Manufacturer

Bristol-Myers Squibb Company.

Orencia Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Orencia.Orencia (abatacept) – Bristol-Myers Squibb Company

What is Omnitrope?

Omnitrope is a form of human growth hormone important for the growth of bones and muscles.

Omnitrope is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with with Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes.

Omnitrope may also be used for purposes not listed in this medication guide.

Warnings

You should not use Omnitrope if you have cancer, eye problems caused by diabetes, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use Omnitrope if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Before you receive Omnitrope, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using Omnitrope. Do not stop using a steroid suddenly or change any of your medication doses without your doctor’s advice.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

Before taking this medicine

You should not use Omnitrope if you are allergic to somatropin or benzyl alcohol, or if you have:

• a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

To make sure Omnitrope is safe for you, tell your doctor if you have:

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

It is not known whether Omnitrope will cause harm to an unborn baby when used by a pregnant woman.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Omnitrope contains benzyl alcohol, an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.

How should I use Omnitrope?

Use Omnitrope exactly as prescribed by your doctor. Your dose will depend on what you are being treated for. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Omnitrope is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Your care provider will show you the best places on your body to inject Omnitrope. Use a different place each time you give an injection. Do not inject Omnitrope into the same place two times in a row.

Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using Omnitrope, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes may also need to be checked.

If you have Prader-Willi syndrome, your treatment program may also include weight control. Follow your doctor’s instructions very closely.

Throw away any Omnitrope left over after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using Omnitrope?

Get emergency medical help if you have signs of an allergic reaction to Omnitrope: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Omnitrope. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints;
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem – extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common Omnitrope side effects may include:

• swelling, rapid weight gain;
• muscle or joint pain;
• headache; or
• pain, itching, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Omnitrope?

Tell your doctor about all your current medicines, and those you start or stop using during your treatment with Omnitrope, especially:

• birth control pills or hormone replacement therapy
• insulin or oral diabetes medicine; or
• steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Omnitrope Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 11 for Omnitrope.Accretropin (somatropin) – Emergent Biosolutions Canada Inc.

What is ondansetron?

Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.

Ondansetron may be used for purposes not listed in this medication guide.

Warnings

You should not use ondansetron if you are also using apomorphine (Apokyn).

You should not use ondansetron if you are allergic to it or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi).

Before taking ondansetron, tell your doctor if you have liver disease, or a personal or family history of Long QT syndrome.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Serious side effects of ondansetron include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, anxiety, agitation, shivering, feeling like you might pass out, and urinating less than usual or not at all. Stop taking this medicine and call your doctor at once if you have any of these side effects. Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking ondansetron

You should not use ondansetron if:

• you are also using apomorphine (Apokyn); or
• you are allergic to ondansetron or similar medicines (dolasetron, granisetron, palonosetron).

To make sure ondansetron is safe for you, tell your doctor if you have:

• liver disease;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• congestive heart failure, slow heartbeats;
• a personal or family history of long QT syndrome; or
• a blockage in your digestive tract (stomach or intestines).

Ondansetron is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ondansetron is not approved for use by anyone younger than 4 years old.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

How should I take ondansetron?

Take ondansetron exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ondansetron can be taken with or without food.

The first dose is usually taken before the start of your surgery, chemotherapy, or radiation treatment. Follow your doctor’s dosing instructions very carefully.

Take the ondansetron regular tablet with a full glass of water.

To take the orally disintegrating tablet (Zofran ODT):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
• Swallow several times as the tablet dissolves.

To use ondansetron oral soluble film (strip) (Zuplenz):

• Keep the strip in the foil pouch until you are ready to use the medicine.
• Using dry hands, remove the strip and place it on your tongue. It will begin to dissolve right away.
• Do not swallow the strip whole. Allow it to dissolve in your mouth without chewing.
• Swallow several times after the strip dissolves. If desired, you may drink liquid to help swallow the dissolved strip.
• Wash your hands after using Zuplenz.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture, heat, and light. Store liquid medicine in an upright position.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include sudden loss of vision, severe constipation, feeling light-headed, or fainting.

What to avoid

Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ondansetron side effects

Get emergency medical help if you have signs of an allergic reaction to ondansetron: rash, hives; fever, chills, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe constipation, stomach pain, or bloating;
• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• fast or pounding heartbeats;
• jaundice (yellowing of the skin or eyes);
• blurred vision or temporary vision loss (lasting from only a few minutes to several hours);
• high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common ondansetron side effects may include:

• diarrhea or constipation;
• headache;
• drowsiness; or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Dosing information

Usual Adult Dose of Ondansetron for Nausea/Vomiting — Chemotherapy Induced:

Oral:
Highly Emetogenic Cancer Chemotherapy (HEC):
-Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater)

Moderately Emetogenic Cancer Chemotherapy (MEC):
-Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy

Parenteral:
-Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy and subsequent doses given 4 and 8 hours after the first dose.
-Maximum dose: 16 mg per dose

Comments:
-Multi-day, single-dose administration of 24 mg orally for HEC has not been studied.
-The injection formulation should be diluted prior to IV administration.

Uses:
-Prevention of nausea and vomiting associated with HEC or MEC
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

Usual Adult Dose of Ondansetron for Nausea/Vomiting:

Oral:
Highly Emetogenic Cancer Chemotherapy (HEC):
-Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater)

Moderately Emetogenic Cancer Chemotherapy (MEC):
-Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy

Parenteral:
-Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy and subsequent doses given 4 and 8 hours after the first dose.
-Maximum dose: 16 mg per dose

Comments:
-Multi-day, single-dose administration of 24 mg orally for HEC has not been studied.
-The injection formulation should be diluted prior to IV administration.

Uses:
-Prevention of nausea and vomiting associated with HEC or MEC
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

Usual Adult Dose of Ondansetron for Nausea/Vomiting — Postoperative:

Oral:
-Recommended dose: 16 mg orally 1 hour before the induction of anesthesia

Parenteral:
-Recommended dose: 4 mg IV (undiluted) immediately before induction of anesthesia or postoperatively (nausea and/or vomiting within 2 hours after surgery)
-Alternative route: 4 mg IM (undiluted)

Comment:
-Administration of a second dose does not provide additional control of nausea and vomiting.

Use:
-Prevention of postoperative nausea and vomiting

Usual Adult Dose for Nausea/Vomiting–Radiation Induced:

Recommended dose: 8 mg orally 3 times a day
-Total Body Irradiation: 8 mg orally 1 to 2 hours before each fraction of radiotherapy administered each day
-Single High-dose Fraction Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after the completion of radiotherapy
-Daily Fractionated Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given

Use:
-Prevention of nausea and vomiting associated with radiotherapy, either as total body irradiation, single high-dose fraction, or daily fractions to the abdomen

Usual Pediatric Dose for Nausea/Vomiting — Postoperative:

Parenteral:
1 month to 12 years:
Less than 40 kg:
-Recommended dose: 0.1 mg/kg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)

40 kg and greater:
-Recommended dose: 4 mg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)

Use:
-Prevention of postoperative nausea and vomiting

Usual Pediatric Dose for Nausea/Vomiting — Chemotherapy Induced:

Oral:
4 to 11 years:
-Recommended dose: 4 mg orally 3 times a day, with the first dose administered 30 minutes before the start of chemotherapy, and subsequent doses 4 and 8 hours after the first dose; then 4 mg orally 3 times a day (every 8 hours) for 1 to 2 days after the completion of chemotherapy

12 years and older:
-Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy

Parenteral:
6 months to 18 years:
-Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy, and subsequent doses given 4 and 8 hours after the first dose
-Maximum dose: 16 mg (per dose)

Comments:
-The injection formulation should be diluted in 50 mL prior to IV administration.
-This drug should be used to prevent nausea and vomiting associated with moderately to highly emetogenic chemotherapy.

Uses:
-Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

What other drugs will affect ondansetron?

Ondansetron can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ondansetron.

Taking ondansetron while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;
• medicine to treat a psychiatric disorder;
• a narcotic (opioid) medication; or
• medicine to prevent nausea and vomiting.

This list is not complete and many other drugs can interact with ondansetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

What is Opill?

Opill is an OTC birth control pill used to prevent pregnancy that is available without a prescription. Opill (norgestrel) is progestin-only contraceptive pill and is sometimes called a minipill, it does not contain estrogen. Opill works mainly by thickening your cervical mucus, which makes it difficult for sperm to reach the egg, and it may suppress the release of an egg from your ovary.

How effective is Opill? When Opill is taken correctly approximately 98 out of 100 sexually active women who used Opill for one year did not become pregnant, in clinical trials.

Opill birth control pill starts working 2 days after you start taking it, but you must take it every day at the same time each day for it to continue to be effective. You must take Opill continuously every day without a break between blister packs.

Opill birth control pill will not protect against HIV/AIDS or other sexually transmitted diseases.

Opill was FDA-approved for OTC (over-the-counter) use on July 13, 2023, and will be available in stores and online in March 2024.

Is Opill an OTC medicine?

Yes, Opill is the first daily birth control pill available OTC without a prescription in the United States.

You should not take Opill:

• if you currently have or have ever had breast cancer
• if you are already pregnant or think you may be pregnant
• with another birth control pill, vaginal ring, patch, implant, injection, or an IUD (intra-uterine device)
• as an emergency contraceptive (morning-after pill). Opill will not prevent pregnancy when used after unprotected sex.

Should I talk to a doctor before taking Opill?

If you have any of the following medical conditions, it is best to talk to a doctor before taking Opill:

• currently have vaginal bleeding between your periods, and you have not already talked to a doctor about it
• have liver problems
• have or ever had any cancer
• are taking a prescription medicine for seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension
• you are taking a supplement containing St John’s Wort (an herbal ingredient)
• you have taken ulipristal acetate (an emergency contraceptive or morning-after pill) in the past 5 days.

Pregnancy

Talk to your healthcare provider right away if you think that you are pregnant. If you become pregnant while using this medicine, you should stop taking it and talk to your doctor. Occasionally, taking oral contraceptives such as Opill may increase your risk of having an ectopic pregnancy. This means that the pregnancy is outside of the uterus. Symptoms of an ectopic pregnancy are unusual vaginal bleeding or lower stomach area (abdominal) pain. Seek medical help immediately.

Opill will not delay your ability to get pregnant when you stop taking this medicine.

Breastfeeding

Although small amounts of progestin may pass into breast milk, Opill is considered safe and effective in breastfeeding women. No adverse effects have been found on either breastfeeding performance or infant health.

Warnings

Allergies. Do not take Opill if you are allergic to norgestrel or any of the inactive ingredients. Do not take Opill if you are allergic to FD C Yellow No. 5 (tartrazine). Some people who are allergic to aspirin can also have a tartrazine allergy. Symptoms include hives, facial swelling, asthma (wheezing), shock, skin redness, rash, and blisters. If you have symptoms of an allergic reaction, stop this medicine and seek medical help immediately. For a full list of ingredients .

Opill can increase the risk of:

• Ectopic pregnancy, be aware of the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on Opill. Seek medical help if you have symptoms of an ectopic pregnancy, such as sudden or severe persistent pain in your lower belly, mainly on one side.
• Delayed follicular atresia/ovarian cysts, in some cases, they are associated with mild abdominal pain, and rarely they may twist or rupture, requiring surgical intervention.
• Bleeding pattern alterations, and irregular menstrual patterns are common among women using Opill. Undiagnosed abnormal uterine bleeding should be evaluated before Opill is taken. If uterine bleeding, together with the clinical history, is suggestive of infection, malignancy, pregnancy, or other conditions, rule out these conditions. If periods stop altogether, consider the possibility of pregnancy.
• Hepatic neoplasia/liver disease, stop Opill if jaundice or acute disturbances of liver function develop. Seek medical help if you have symptoms such as yellowing of your skin or whites of your eyes, especially if you have a fever, tiredness, loss of appetite, or dark-colored urine.

Opill dosing information

Take 1 tablet at the same time every day

• This tablet works best to prevent pregnancy when taken exactly as directed.
• You can start on any day of your cycle.
• Opill takes 48 hours (2 days) to start working. Use condoms (or another barrier contraceptive method) every time you have sex during the first 2 days of use after you start your first pack of Opill.

Never skip your daily tablet

• To prevent pregnancy, you need to take your tablet every day, even when you bleed or have spotting.
• When you finish a pack, you should start the next one the following day without a break.

If you are more than 3 hours late taking your tablet or miss taking your tablet on 1 or more days

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

If you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet

• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

When do I need to use extra contraceptive protection?

You need to use extra contraceptive protection (condoms or another form of barrier contraception) every time you have sex for the next 2 days (48 hours)

• After you start your first pack.
• If you take a tablet more than 3 hours late or miss a tablet on 1 or more days.
• If you vomit or have severe diarrhea within 4 hours of taking a tablet.

Take a pregnancy test or talk to your doctor if:

• Your period is late after missing taking your tablets in the last month
• If you have not had a period for 2 months and believe you may be pregnant.
• Stop using this medicine, and talk to your doctor if you become pregnant while on the medication.

It is important to continue to see your healthcare provider for your regular healthcare visits.

Opill side effects

The most common Opill side effect is changes in menstrual periods (bleeding).

Less common Opill side effects include:

• headache
• dizziness
• nausea
• increased appetite
• abdominal pain, cramps and bloating
• fatigue
• vaginal discharge
• painful periods
• nervousness
• backache
• breast discomfort
• acne

You should talk to your doctor if:

• You have repeated vaginal bleeding after having sex.
• Your periods start lasting more than 8 days, or they are unusually heavy.
• You start having migraines with aura (headaches that start with vision changes), or if your migraine headaches get worse.

What happens if I miss a dose?

If you are more than 3 hours later taking your tablet or miss taking your tablet on 1 or more days:

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days), because the medicine may not be effective.

What happens if I overdose?

Symptoms of overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence (drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms.

What other drugs will affect Opill?

Tell your pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Opill may affect the way other medicines work, and vice versa.

It is very important to tell your healthcare provider if you take any of the following medicines that have drug interactions with Opill:

• phenytoin
• carbamazepine
• barbiturates
• rifampin
• efavirenz
• bosentan
• ulipristal acetate
• any herbal preparations containing St. John’s Wort (hypericum perforatum).

What is Ongentys?

Ongentys is a prescription medicine that inhibits the enzyme catechol-O-methyltransferase (COMT). COMT is involved in the degradation of certian neurotransmitters such as dopamine, epinephrine, and norepinephrine.

Ongentys is used together with carbidopa and levodopa to treat symptoms of “off” episodes (stiffness, tremors, muscle spasms, poor muscle control) in people with Parkinson’s disease.

It is not known if Ongentys is safe and effective in children.

Warnings

Do not use Ongentys if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.

Do not use Ongentys if you have a tumor that secretes hormones known as catecholamines. These tumors include pheochromocytoma (a type of adrenal gland tumor) and paraganglioma.

Before taking this medicine

You should not use Ongentys if you are allergic to opicapone, or if you have a certain type of tumor that secretes hormones, such as:

• pheochromocytoma (tumor of the adrenal gland); or
• paraganglioma (tumor of the nerve cells).

To make sure Ongentys is safe for you, tell your doctor if you have ever had:

• a sleep disorder that causes daytime sleepiness;
• narcolepsy or other conditions that cause sudden sleepiness;
• uncontrolled muscle movements;
• unusual and intense urges to act on impulse (such as gambling, binge-eating, or compulsive shopping);
• mental illness, hallucinations, or psychosis;
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Ongentys?

Take Ongentys exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

When you start or stop taking Ongentys, your doctor may need to adjust the doses of any other medicines you take for Parkinson’s disease.

Ongentys is usually taken at bedtime. Follow your doctor’s dosing instructions very carefully.

Take Ongentys on an empty stomach. Do not eat for at least 1 hour before or 1 hour after taking this medicine.

Your blood pressure may need to be checked often.

Ongentys may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Do not change your doses or stop using any of your medicines without your doctor’s advice. Tell your doctor if any of your medicines seem to stop working.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

50 mg orally once a day at bedtime

Use: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes

What happens if I miss a dose?

Skip the missed dose and use your next dose the following night. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ongentys side effects

Get emergency medical help if you have signs of an allergic reaction to Ongentys: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• confusion, hallucinations (hearing or seeing something that is not there);
• aggression, agitation, unusual thoughts or behavior;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• worsening tremors, stiffness, or muscle spasms.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Ongentys side effects may include:

• feeling light-headed;
• uncontrolled muscle movement;
• abnormal blood tests;
• constipation; or
• weight loss.

When you stop taking Ongentys, watch for withdrawal symptoms such as: stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, or feeling like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Ongentys?

Using Ongentys with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• dobutamine;
• dopamine;
• epinephrine, norepinephrine; or
• isoproterenol.

What is Onureg?

Onureg is a prescription medicine used for continued treatment of adults with acute myeloid leukemia (AML) who:

• had a first complete remission (CR) following intensive induction chemotherapy with or without recovery of your blood cell counts, and
• who are not able to complete intensive curative therapy.

It is not known if Onureg is safe and effective in children under 18 years of age.

Warnings

Both men and women using Onureg should use effective birth control to prevent pregnancy. Azacitidine can harm an unborn baby if the mother or father is using this medicine.

Before taking this medicine

You should not use Onureg if you are allergic to azacitidine.

To make sure Onureg is safe for you, tell your doctor if you have:

• kidney disease; or
• liver disease.

Azacitidine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use Onureg if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine. If you take Onureg, keep using birth control for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. If you take Onureg, keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Onureg.

Onureg may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because this medicine can harm an unborn baby.

You should not breastfeed while using Onureg. Also do not breastfeed for at least 1 week after your last dose of Onureg.

How should I use Onureg?

Use Onureg exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Onureg tablets are taken by mouth in a 28-day treatment cycle. You may need to take the medicine only during the first 2 weeks of each cycle.

Take Onureg at the same time each day, with or without food. Swallow the tablet whole and do not crush, chew, or break it.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

If you vomit shortly after taking Onureg, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your treatment schedule may be different. Your doctor will determine how long to treat you with azacitidine. Onureg tablets should not be used in place of Vidaza (azacitidine) injection. The oral and injection forms of this medicine have different uses and dosages.

You may also be given medicine to reduce nausea and vomiting. Use this medicine only as prescribed.

Azacitidine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney function may also need to be tested.

Store Onureg at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Keep the container tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Onureg?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Onureg side effects

Get emergency medical help if you have signs of an allergic reaction to Onureg: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;
• redness, swelling, warmth, oozing, or other signs of skin infection;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of a lung infection–fever, cough with mucus, chest pain, feeling short of breath;
• kidney problems–pain in your lower back, blood in your urine, little or no urination, swelling in your feet or ankles;
• liver problems–upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low potassium level–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of tumor cell breakdown–tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common Onureg side effects may include:

• fever, chills, bruising, or other signs of low blood cell counts;
• lung infection;
• low potassium;
• nausea, vomiting, stomach pain, loss of appetite;
• constipation, diarrhea;
• joint pain, pain in your arms or legs;
• feeling weak or tired; or
• dizziness.

What is Opdivo?

Opdivo is used to treat many cancers, such as melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, liver cancer, esophageal squamous cell carcinoma, gastric cancer, and gastroesophageal junction cancer. It is given as an intravenous infusion (infusion into your vein; IV) over 30 minutes, every 2 to 4 weeks, depending on the type of cancer.

Opdivo is not chemotherapy; it is an immunotherapy treatment that can be used by itself, with chemotherapy, or with other immunotherapy treatments, such as Yervoy, another checkpoint inhibitor. Opdivo targets the PD-1 protein, while Yervoy targets the CTLA-4 protein.

Opdivo first gained FDA approval in 2014. There is no generic or biosimilar.

Mechanism

Opdivo works by interfering with the growth and spread of cancer cells in the body through a process called immune checkpoint inhibition.

• Normally, cancer cells can evade the immune system by expressing proteins called PD-L1 (programmed death-ligand 1) on their surface, which bind to PD-1 receptors on T cells.
• When PD-L1 binds to PD-1, it sends a “stop” signal to T cells, preventing them from attacking the cancer cells – essentially creating an “off switch” for the immune response.
• Opdivo is a monoclonal antibody that specifically blocks the PD-1 receptors on T cells, preventing this binding from occurring.
• By blocking this interaction, Opdivo removes the “brake” on the immune system, allowing T cells to recognize and attack cancer cells.

This reactivation of the immune response can lead to tumor shrinkage and improved survival in patients with certain types of cancer, including melanoma, lung cancer, renal cell carcinoma, and various other malignancies.

Clinical trials have shown most people respond to Opdivo within 2-3 months of starting treatment .

The effectiveness of Opdivo varies depending on the cancer type and stage and other factors .

Opdivo Vs Opdivo Qvantig

Opdivo Qvantig is a formulation of Opdivo containing hyaluronidase, which allows it to be given subcutaneously (under the skin) over 3 to 5 minutes, instead of intravenously over 30 minutes. 

• Opdivo Qvantig offers faster administration but has more restricted approved uses.

FDA approvals and uses

Opdivo is approved to treat the following cancers:

• Melanoma in adults and children 12 years and older
  • Unresectable/metastatic melanoma (single agent or with ipilimumab)
  • Adjuvant treatment for completely resected Stage IIB-IV melanoma
• Non-small cell lung cancer (NSCLC) in adults
  • Neoadjuvant treatment for resectable tumors ≥4cm or node-positive (with platinum-doublet chemotherapy)
  • Metastatic NSCLC with PD-L1 ≥1%, no EGFR/ALK mutations (first-line with ipilimumab)
  • Metastatic/recurrent NSCLC, no EGFR/ALK mutations (first-line with ipilimumab + 2 cycles platinum-doublet chemotherapy)
  • Metastatic NSCLC with progression after platinum-based therapy
• Malignant pleural mesothelioma in adults
  • Unresectable disease (first-line with ipilimumab)
• Renal cell carcinoma (RCC) in adults
  • Intermediate/poor risk advanced RCC (first-line with ipilimumab)
  • Advanced RCC (first-line with cabozantinib)
  • Advanced RCC after prior anti-angiogenic therapy
• Classical Hodgkin Lymphoma in adults
  • Relapsed/progressed after autologous stem cell transplant and brentuximab vedotin
  • After ≥3 systemic therapy lines, including autologous stem cell transplant
• Squamous cell cancer of the head and neck in adults
  • Recurrent/metastatic disease with progression after platinum-based therapy
• Urothelial carcinoma in adults
  • Adjuvant treatment for high-risk recurrence after radical resection
  • Unresectable/metastatic disease (first-line with cisplatin and gemcitabine)
  • Locally advanced/metastatic with progression during/after platinum therapy or within 12 months of neoadjuvant/adjuvant platinum therapy
• Colorectal cancer in adults and children 12 years and older
  • Unresectable/metastatic MSI-H or dMMR colorectal cancer (with ipilimumab)
  • MSI-H or dMMR metastatic disease progressed after fluoropyrimidine, oxaliplatin, and irinotecan
• Hepatocellular carcinoma (HCC) in adults
  • Unresectable/metastatic HCC (first-line with ipilimumab)
  • Previously treated with sorafenib (with ipilimumab)
• Esophageal cancer in adults
  • Completely resected esophageal/gastroesophageal junction cancer with residual disease after neoadjuvant chemoradiotherapy
  • Unresectable advanced/metastatic esophageal squamous cell carcinoma, PD-L1 ≥1% (first-line with chemotherapy or ipilimumab)
  • Unresectable advanced/recurrent/metastatic esophageal squamous cell carcinoma after prior chemotherapy
• Gastric/gastroesophageal junction cancer and esophageal adenocarcinoma in adults
  • Advanced/metastatic disease with PD-L1 ≥1% (with fluoropyrimidine and platinum-containing chemotherapy).
  • This indication is under the accelerated approval designation meaning continued approval may be contingent upon a clinical benefit in confirmatory trials.

Opdivo is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Clinical trials have shown Opdivo and Yervoy work better when taken together for some types of cancer .

Side effects

The most common side effects of Opdivo when used alone are:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation
• mouth sores, altered sense of taste
• itching, rash, redness, or blisters on your hands or feet
• hormonal problems
• liver problems
• numbness, tingling, or burning pain in your hands or feet
• fever, body aches
• feeling weak, tired, or short of breath
• cold symptoms such as runny or stuffy nose, cough, sore throat
• headache, dizziness, increased blood pressure
• weight loss.

The most common side effects of Opdivo and Yervoy in combination are:

• constipation
• cough
• decreased appetite
• decreased weight
• diarrhea
• dizziness
• feeling tired
• fever
• headache
• itching
• low thyroid hormone levels (hypothyroidism)
• nausea
• pain in muscles, bones, and joints
• rash
• shortness of breath
• stomach-area (abdominal) pain
• upper respiratory tract infection
• vomiting.

Serious side effects and warnings

Opdivo can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Immune system problems. Opdivo is a medicine that may treat certain cancers by working with your immune system. Opdivo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended, and may be more common when Opdivo is used in combination with other treatments. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

• Lung problems
  • new or worsening cough
  • shortness of breath
  • chest pain.
• Intestinal problems
  • diarrhea (loose stools) or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • hair loss
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased
  • sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems
  • decrease in your amount of urine
  • swelling in your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes.

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with nivolumab. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising.

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), may occur in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you undergo transplantation either before or after being treated with Opdivo. Your healthcare provider will monitor you for these complications.

Opdivo can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

Get emergency medical help if you have signs of an allergic reaction to Opdivo (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Opdivo. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Opdivo if you have severe side effects.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Opdivo may cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with Opdivo.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

To make sure Opdivo is safe for you, tell your doctor if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past, and have received other medicines that are similar to Opdivo
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Opdivo may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving Opdivo and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if Opdivo passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is Opdivo administered?

Opdivo is given as an infusion into a vein (IV infusion) by a healthcare provider. This medicine must be given slowly over 30 minutes.

• Opdivo is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• The dosage of Opdivo depends on the cancer being treated and the patient’s age (see the Opdivo Prescribing Information for complete Opdivo dosing information).
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo.
• Opdivo can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Opdivo?

Follow your doctor’s instructions about restricting food, beverages, or activity.

What other drugs will affect Opdivo?

Other drugs may interact with Opdivo, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.

Drug class: Proton pump inhibitors 

What is omeprazole?

Omeprazole is used to treat excess stomach acid in conditions such as non cancerous stomach ulcers, gastroesophageal reflux disease (GERD), active duodenal ulcer, Zollinger-Ellison syndrome and erosive esophagitis. Omeprazole works by blocking gastric acid production and is from the group of medicines called proton pump inhibitors.

Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with Helicobacter pylori (H. pylori).

Over-the-counter (OTC) omeprazole is used in adults to help control heartburn that occurs 2 or more days per week. The OTC brand must be taken as a course on a regular basis for 14 days in a row.

Warnings

Omeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Omeprazole is not to used for the immediate relief of heartburn symptoms.

Omeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel sweaty or light-headed.

You should not use omeprazole if you are allergic to it, or if:

• you are also allergic to medicines like omeprazole, such as esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others;
• you had breathing problems, kidney problems, or a severe allergic reaction after taking omeprazole in the past; or
• you also take HIV medication that contains rilpivirine (such as Complera, Edurant, Odefsey, Juluca).

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• trouble or pain with swallowing;
• bloody or black stools, vomit that looks like blood or coffee grounds;
• heartburn that has lasted for over 3 months;
• frequent chest pain, heartburn with wheezing;
• unexplained weight loss;
• nausea or vomiting, stomach pain;
• liver disease;
• low levels of magnesium in your blood; or
• osteoporosis or low bone mineral density (osteopenia).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

How should I take omeprazole?

Take omeprazole exactly as directed on the label, or as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Use Prilosec OTC (over-the-counter) exactly as directed on the label, or as prescribed by your doctor.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

You must dissolve omeprazole powder in a small amount of water. This mixture can either be swallowed or given through a nasogastric (NG) feeding tube using a catheter-tipped syringe.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

OTC omeprazole should be taken for only 14 days in a row. It may take 1 to 4 days before your symptoms improve. Allow at least 4 months to pass before you start a new 14-day course of treatment.

Call your doctor if your symptoms do not improve, or if they get worse.

Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Omeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Omeprazole side effects

Get emergency medical help if you have signs of an allergic reaction to omeprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• new or unusual pain in your wrist, thigh, hip, or back;
• seizure (convulsions);
• kidney problems – fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• low magnesium – dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or
• new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking omeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use this medicine for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects of omeprazole may include:

• cold symptoms such as stuffy nose, sneezing, sore throat (especially in children);
• fever (especially in children);
• stomach pain, gas;
• nausea, vomiting, diarrhea; or
• headache.

What is Omega-3 Fish Oil?

Certain prescription Omega-3 Fish Oil are used in adults, together with diet to help lower triglyceride levels in the blood.

Omega-3 Fish Oil may also be used in combination with other vitamins in adults and children as a dietary supplement.

Omega-3 Fish Oil may also be used for purposes not listed in this medication guide.

Omega-3 Fish Oil side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Omega-3 Fish Oil may cause serious side effects. Call your doctor at once if you have:

• chest pain; or
• uneven heartbeats.

Common side effects of Omega-3 Fish Oil may include:

• burping, changes in your sense of taste;
• loss of appetite;
• diarrhea, constipation, upset stomach;
• back pain; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed and follow all directions on the label and package. Tell each of your healthcare providers if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use Omega-3 Fish Oil if you are allergic to Omega-3 Fish Oil, soy, fish or shellfish.

Ask your doctor or pharmacist before taking Omega-3 Fish Oil if you have any health problems.

Tell your doctor if you have or have ever had:

• diabetes;
• bleeding problems, anemia (low red blood cells);
• a heart rhythm disorder;
• a pancreas disorder;
• underactive thyroid; or
• liver disease.

It is not known if Omega-3 Fish Oil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Omega-3 Fish Oil.

Do not give any herbal or health supplement to a child without medical advice.

How should I take Omega-3 Fish Oil?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use more of this product than is recommended on the label.

The recommended daily dose of omega-3 polyunsaturated fatty acids changes with age. Follow your healthcare provider’s instructions. You may also consult the Office of Dietary Supplements of the NIH, or the USDA Nutrient Database of recommended daily allowances for more information.

Over the counter (OTC) products should not be used to replace medication prescribed for you by your doctor. Ask your doctor, pharmacist, or other healthcare provider if it is safe to use this product.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You must chew the chewable tablet before you swallow it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Your treatment may also include diet, exercise, weight control, and blood tests.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line

What should I avoid while taking Omega-3 Fish Oil?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Avoid using Omega-3 Fish Oil together with other herbal/health supplements that can also affect blood-clotting. This includes angelica (dong quai), capsicum, clove, dandelion, danshen, evening primrose, garlic, ginger, ginkgo, horse chestnut, Panax ginseng, poplar, red clover, saw palmetto, turmeric, and willow.

What is Opzelura?

Opzelura is used to treat atopic dermatitis (eczema) and nonsegmental vitiligo. It is a topical cream that is applied thinly twice a day. Do not exceed the maximum dose of (1 x 60-gram tube/week or 1 x 100-gram tube/week).

Opzelura works by blocking JAK1 and JAK2 enzymes, which normally help immune signals communicate between cells. These enzymes activate STAT proteins that travel to the cell nucleus to control gene expression. By inhibiting JAKs, Opzelura disrupts this signaling pathway, reducing overactive immune responses that cause inflammatory skin conditions like vitiligo and atopic dermatitis. It belongs to the drug class called kinase inhibitors.

Opzelura (ruxolitinib 1.5%) gained FDA approval on September 21, 2021. There is no generic.

FDA approvals and indications

Opzelura is FDA approved for:

• Mild to moderate atopic dermatitis in non-immunocompromised adults and children 12 years of age and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended (short-term and non-continuous chronic treatment only)
• Nonsegmental vitiligo in adults and children 12 years of age and older.

The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

It is not known if this medicine is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo.

Important: Opzelura is for use on the skin only. Do not use Opzelura in your eyes, mouth, or vagina.

Side effects

The most common side effects of Opzelura for atopic dermatitis are:

• common cold (nasopharyngitis)
• diarrhea
• bronchitis
• ear infection
• increase in a type of white blood cell
• (eosinophil) count
• hives
• inflamed hair pores (folliculitis)
• swelling of the tonsils (tonsillitis)
• runny nose (rhinorrhea).

The most common side effects of Opzelura for non-segmental vitiligo are:

• acne at the application site
• itching at the application site
• common cold (nasopharyngitis)
• headache
• urinary tract infection
• redness at the application site
• fever.

Serious side effects and warnings

Opzelura may cause the following serious side effects:

• Serious Infections. Opzelura contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while using Opzelura.
  • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with Opzelura.
  • Opzelura should not be used in people with an active, serious infection, including localized infections. You should not start using Opzelura if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using Opzelura.
  • Before starting Opzelura, tell your healthcare provider about all your current medical conditions (see below).

After starting Opzelura, call your healthcare provider right away if you have any symptoms of an infection. Opzelura can make you more likely to get infections or make any infections worse that you have. If you get a serious infection, your healthcare provider may stop your treatment with Opzelura until your infection is controlled.

• Increased risk of death due to any reason (all causes). Increased risk of death has occurred in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.
• Cancer and immune system problems. Opzelura may increase your risk of certain cancers by changing the way your immune system works.
  • Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth.
  • People taking JAK inhibitors by mouth have a higher risk of certain cancers, including lymphoma and lung cancer, especially if they are a current or past smoker.
  • Some people have had skin cancers while using Opzelura. Your healthcare provider will regularly check your skin during your treatment with Opzelura. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.
  • Tell your healthcare provider if you have ever had any type of cancer.
• Increased risk of major cardiovascular events. Increased risk of major cardiovascular events such as heart attack, stroke, or death has occurred in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Get emergency help right away if you have any symptoms of a heart attack or stroke while using Opzelura, including:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech.
• Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking Opzelura. This may be life-threatening. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor, taking a medicine in the class of medicines called JAK inhibitors by mouth. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past.

Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Opzelura, including:

• • swelling, pain, or tenderness in one or both legs
  • sudden, unexplained chest or upper back pain
  • shortness of breath or difficulty breathing
• Low blood cell counts. Opzelura may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with Opzelura and may stop your treatment if signs or symptoms of low blood cell counts happen. Tell your healthcare provider right away if you develop or have worsening of any of these symptoms:
  • unusual bleeding o shortness of breath
  • bruising
  • fever
  • tiredness.
• Cholesterol increases. An increase in cholesterol levels has been reported in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high levels of fat in your blood (high cholesterol or triglycerides)

These are not all of the possible side effects of Opzelura. Call your doctor for medical advice about side effects.

Before applying

Before using Opzelura, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are a current or past smoker
• have had a heart attack, other heart problems, or a stroke
• have or have had low white or red blood cell counts
• have high levels of fat in your blood (high cholesterol or triglycerides)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Opzelura will harm your unborn baby.

Pregnancy Exposure Registry. There is a pregnancy exposure registry for individuals who use Opzelura during pregnancy. The purpose of this registry is to collect information about your health and your baby’s. If you become exposed to Opzelura during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or by visiting www.opzelura.pregnancy.incyte.com.

Breastfeeding

It is not known if Opzelura passes into your breast milk. Do not breastfeed during treatment with Opzelura and for about 4 weeks after the last dose.

How should I use Opzelura?

Opzelura is for use on the skin only. Do not use Opzelura in your eyes, mouth, or vagina. Use it exactly as your healthcare provider tells you. Ask your healthcare provider if you have questions about applying Opzelura.

• Apply a thin layer of Opzelura 2 times a day to affected areas.

Do not use more than one 60-gram tube each week or more than one 100-gram tube every 2 weeks.

If you are using Opzelura for atopic dermatitis, stop using Opzelura when your signs and symptoms of atopic dermatitis, such as itching, rash, and redness, go away, or as directed by your healthcare provider.

• Tell your healthcare provider if your symptoms do not improve within 8 weeks of treatment.

If you are using Opzelura for non-segmental vitiligo, tell your healthcare provider if your treated skin does not improve within 24 weeks of treatment.

• Wash your hands after applying Opzelura, unless your hands are being treated. If someone else applies Opzelura, they should wash their hands after applying Opzelura.

Dosing information

Dose of Opzelura for atopic dermatitis

• Apply a thin layer 2 times a day to affected areas of up to 20% body surface area.

Dose of Opzelura for nonsegmental vitiligo

• Apply a thin layer 2 times a day to affected areas of up to 10% body surface area.

What other drugs will affect Opzelura?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What is Orgovyx?

Orgovyx tablet (relugolix) is a prescription medicine used to treat advanced prostate cancer (cancer that begins in the prostate) in adult men. Orgovyx is a once-daily tablet that quickly and effectively decreases testosterone (a male hormone) levels. This helps to slow or stop the spread of prostate cancer cells that need testosterone to grow.

How does Orgovyx work?

Orgovyx works (mechanism of action) by binding and blocking GnRH receptors in the pituitary gland. Blocking GnRH receptors reduces the production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which in turn lowers testosterone levels in the body. Since most prostate cancer cells depend on testosterone to grow, Orgovyx helps slow or stop cancer cell growth by effectively reducing testosterone production.

How well does Orgovyx work?

Orgovyx was fast and effective at suppressing testosterone in advanced prostate cancer in the Orgovyx HERO clinical trial (NCT03085095)

Orgovyx effective testosterone suppression: 

• 96.7% of Orgovyx patients maintained castrate levels (<50 ng/dL) from day 29 through to 48 weeks vs. 88.8% with leuprolide.

Faster action:

• Day 4: 56% of Orgovyx patients reached castrate levels vs. 0% with leuprolide.
• Day 15: 99% of Orgovyx patients achieved suppression vs. 12% with leuprolide.

Orgovyx side effects

Common Orgovyx side effects

Common Orgovyx side effects may include:

• Hot flush (54%) 
• High blood sugar (44%)
• Triglycerides increased (35%)
• Muscle or joint pain (30%)
• Feeling tired, fatigue (26%)
• Alanine aminotransferase increased – ALT (27%)
• Aspartate aminotransferase increased – AST (18%)
• Diarrhea (12%)
• Constipation (12%)

The most common Orgovyx side effects occurred in 10% or more of patients, and laboratory changes occurred in 15% or more patients in the HERO clinical trial.

Serious Orgovyx side effects

Get emergency medical help if you have signs of an allergic reaction to Orgovyx: Hives, difficulty breathing, swelling of your face, lips, tongue, or throat, trouble swallowing.

Orgovyx may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• chest pain or pressure;
• sudden numbness or weakness on one side of the body;
• little or no urination, pain or burning when you urinate; or
• unusual bleeding.

Serious side effects occurred in 0.5% or more of patients taking Orgovyx in the HERO clinical trial, included:​

• Myocardial infarction (0.8%)​
• Acute kidney injury (0.6%)​
• Abnormal heart rhythm – Arrhythmia (0.6%)​
• Bleeding: 0.6%​
• Urinary tract infection (0.5%)​

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Orgovyx may decrease fertility in men. Talk to your doctor about the risks.

Orgovyx is intended only for use in men. This medicine is not intended for use alone in women, but can be used in combination with other medications for other uses. If you are a male and your female partner can become pregnant, you should use effective contraception during treatment and for 2 weeks after the last dose. Relugolix may harm the fetus.

Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also, tell your doctor if you have or have ever had an electrolyte imbalance in your blood, heart failure, diabetes, high triglycerides (fatty substances in the blood), anemia, or liver problems.

Tell your doctor and pharmacist if you are allergic to relugolix, any other medications, or any of the ingredients in the tablets. Ask your pharmacist for a list of the ingredients.

Before taking this medicine

You should not use Orgovyx if you are allergic to the active ingredient relugolix, or inactive ingredients, or if you have:

• heart problems; or
• long QT syndrome (in you or a family member).

Pregnancy

Orgovyx can harm an unborn baby and cause loss of pregnancy (miscarriage).

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.
• Tell your doctor if your partner is pregnant or plans to get pregnant.

It may be harder for you to get a woman pregnant while you are using Orgovyx. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take Orgovyx?

Take Orgovyx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Orgovyx’s usual dose is one tablet per day, after the first day, which is 3 tablets. Take the medicine at the same time each day, with or without food.

Swallow the Orgovyx tablet whole, and do not crush, chew, or break the tablet.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiogram or ECG (sometimes called an EKG).

Your doctor will determine how long to treat you with Orgovyx. Do not change your dose or stop using this medicine without your doctor’s advice.

Store tightly closed at room temperature, away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash. Do not flush down the toilet.

Orgovyx dosing information

Usual Adult Orgovyx Dose for Prostate Cancer:

Loading Dose: 360 mg orally once on the first day
Maintenance Dose: 120 mg orally once a day

Comment:
Treatment is usually continued upon the development of nonmetastatic or metastatic castration-resistant prostate cancer in patients treated with GnRH receptor agonists and antagonists.

Use: For the treatment of adult patients with advanced prostate cancer.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Orgovyx?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Orgovyx?

Sometimes, it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Orgovyx can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Certain other drugs should not be used within 6 hours after you take Orgovyx. Your dose should be taken first, before other medicines. Carefully follow your doctor’s instructions about how to schedule the doses of all your medicines.

 P-gp Inhibitors 

• Avoid using Orgovyx with oral P-gp inhibitors as this increases relugolix exposure, which may increase the risk of adverse reactions associated with Orgovyx.

Combined P-gp and Strong CYP3A Inducers

• Avoid coadministration of Orgovyx with combined P-gp and strong CYP3A inducers.
• Using Orgovyx with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of Orgovyx.

What is Oriahnn?

Oriahnn contains a combination of elagolix, estradiol, and norethindrone.

Oriahnn is a prescription medicine used to control heavy menstrual bleeding in adult women with uterine fibroids.

Oriahnn is not for use in women who have entered menopause.

Warnings

Do not use Oriahnn if you are pregnant.

You should not use Oriahnn if you have: uncontrolled high blood pressure, heart disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease, severe migraine headaches, osteoporosis, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Taking Oriahnn can increase your risk of blood clots, stroke, or heart attack. Your risk of these side effects is highest if you are older than 35 and you smoke, or if you have high cholesterol, diabetes, uncontrolled high blood pressure, or if you are overweight.

Stop taking Oriahnn and seek medical attention right away if you have chest pain spreading to your jaw or shoulder, a sudden severe headache, problems with vision or speech, or swelling or pain in your leg.

Before taking this medicine

You should not use Oriahnn if you are allergic to elagolix, estradiol, or norethindrone, or if you have:

• a history of heart attack, stroke;
• a blood clot in your heart, lungs, legs, or eyes;
• blood circulation problems;
• a heart valve disorder or heart rhythm problems;
• uncontrolled high blood pressure;
• problems caused by diabetes that affect your eyes, kidneys, nerves, or blood vessels;
• severe migraine headaches (with aura), especially if you are older than 35;
• gallbladder problems;
• a history of hormone-related cancer (such as cancer of the breast, uterus/cervix, or vagina);
• osteoporosis; or
• abnormal vaginal bleeding that has not been checked by a doctor.

Taking Oriahnn can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take Oriahnn if you smoke and are over 35 years old.

Oriahnn may also cause bone loss, which may be partially permanent. It is not known if this could increase your risk of bone fracture.

Oriahnn is not a birth control medication and will not prevent pregnancy. You may need to have a negative pregnancy test before starting this treatment.

Do not take Oriahnn if you are pregnant or trying to get pregnant. Oriahnn may increase your risk of miscarriage. Use effective birth control to prevent pregnancy while taking this medicine and for 28 days after your last dose.

To prevent pregnancy while using Oriahnn, use a non-hormonal form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Avoid using birth control pills, injections, implants, skin patches, and vaginal rings.

Stop taking Oriahnn and call your doctor right away if you think you might be pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of elagolix, estradiol, and norethindrone on the baby.

Oriahnn may change your menstrual periods (decreased or no bleeding), which could make it harder to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain, and nausea.

To make sure Oriahnn is safe for you, tell your doctor if you have ever had::

• bone problems, including broken bones;
• depression, a mood disorder, or suicidal thoughts; or
• jaundice (yellowing of your skin or eyes) caused by pregnancy or birth control.

How should I take Oriahnn?

Take Oriahnn exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You should not take this medicine for longer than 24 months.

Oriahnn comes in different capsule colors. The white/yellow capsule is usually taken in the morning, and the white/blue capsule is taken in the evening. Follow your doctor’s dosing instructions very carefully.

Take the medicine at the same times each day, with or without food.

Your doctor may have you take extra vitamin D and calcium while you are taking Oriahnn. Take these supplements only as your doctor has prescribed. Avoid taking iron supplements if you also take vitamin D and calcium supplements.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Your blood pressure will need to be checked often. You may also need scans to check your bone mineral density before and during treatment with Oriahnn.

Oriahnn can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

Do not keep leftover capsules. Ask your pharmacist where to locate a drug take-back disposal program. Do not flush the unused medicine down a toilet.

Dosing information

Usual Adult Dose for Uterine Fibroids:

One capsule orally twice a day
-Morning capsule contains elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg
-Evening capsule contains elagolix 300 mg
Duration of therapy: 24 months

Comments:
-Rule out pregnancy prior to starting therapy or start therapy within 7 days from the onset of menses.
-Take capsules twice a day at approximately the same time each day.
-Duration of use should be limited to 24-months due to risk of bone loss.

Use: For the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose may cause nausea, vomiting, stomach pain, breast tenderness, severe drowsiness or tiredness, or vaginal bleeding.

What to avoid

Do not smoke while taking Oriahnn, especially if you are older than 35 years of age.

Grapefruit may interact with elagolix, estradiol, and norethindrone and lead to unwanted side effects. Avoid the use of grapefruit products.

Side Effects

Get emergency medical help if you have signs of an allergic reaction to Oriahnn: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine may increase your risk of heart attack, stroke, or blood clot. Stop using this medicine and seek medical attention right away if you have:

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• swelling, pain, warmth, or redness in an arm or leg;
• sudden shortness of breath;
• sudden numbness, weakness, or severe headache;
• vision problems, bulging eyes; or
• trouble speaking.

Call your doctor at once if you have:

• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• any new or worsening mood symptoms – mood or behavior changes, depression, anxiety, thoughts about suicide or hurting yourself; or
• liver or gallbladder problems – loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, bruising, swelling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Oriahnn may cause hair loss that may be permanent.

Common Oriahnn side effects may include:

• hot flashes;
• feeling tired;
• hair loss (may be permanent);
• headache; or
• irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect this medicine?

Tell your doctor about all your other medicines, especially:

• thyroid medicine; or
• cortisol replacement therapy;

What is Orladeyo?

Orladeyo capsules are used to prevent attacks of hereditary angioedema (HAE), in adults and children aged 12 years and older. Orladeyo works by blocking plasma kallikrein, an enzyme that leads to the production of bradykinin, a substance that causes swelling and pain in hereditary angioedema.

Orladeyo is a once-daily capsule used as a preventative treatment for hereditary angioedema.

Hereditary angioedema is a rare and potentially life-threatening genetic disorder that causes an attack of rapid swelling in the face, throat, arms, legs, or around the abdomen. 

Orladeyo FDA approval was granted to BioCryst Pharmaceuticals, Inc., on December 3, 2020. Orladeyo FDA approval is for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years and older. 

Orladeyo is not used for treating a hereditary angioedema attack that has already begun.

How does Orladeyo work?

In hereditary angioedema, a C1 esterase deficiency leads to the overactivation of plasma kallikrein, which causes high levels of bradykinin, a protein that causes blood vessels to widen and leak, and results in swelling and pain of angioedema attacks.

Orladeyo mechanism of action is by binding to plasma kallikrein which controls excess bradykinin generation, reducing the risk of angioedema attacks

Orladeyo (berotralstat) is from a class of medicines called kallikrein inhibitors.

How well does Orladeyo work?

Orladeyo was shown to be effective in treating hereditary angioedema, with positive results from a 48-week Clinical trial APeX-2 (NCT03485911), which demonstrated that Orladeyo patients had a:

• 67% reduction in hereditary angioedema attack rate using 150mg daily
• 52% reduction in hereditary angioedema attack rate using 110mg daily

Orladeyo side effects

Common Orladeyo side effects 

Common Orladeyo side effects may include: 

• Stomach pain (10%)
• Indigestion (10%)
• Vomiting (10%)
• Diarrhea (10%)
• Back pain (2%) 

These common side effects occurred in 10% or more of Orladeyo patients taking 110mg in the  24-week (Part 1) clinical trial called Trial 1.  Gastrointestinal side effects including abdominal pain, vomiting, and diarrhea occurred more frequently in patients receiving Orladeyo 150 mg. These side effects usually occurred when first starting treatment and became less frequent over time.

Serious side effects

Allergic reaction. Get emergency medical help if you have signs of an allergic reaction to this medicine with symptoms of hives; difficulty breathing; and swelling of your face, lips, tongue, or throat.

QT prolongation. Taking more than one capsule a day may cause serious side effects of heart rhythm problems. QT prolongation is a heart rhythm problem that can happen in people who take more than one capsule a day. This condition can cause an abnormal heartbeat. Do not take more than one capsule a day.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

QT Prolongation Risk: An increase in QT prolongation can occur at dosages higher than the recommended 150 mg once daily dosage. Do not exceed 150 mg per day.

Before taking this medicine

Before taking Orladeyo for HAE make sure this medicine is safe for you, tell your doctor if you have ever had:

• Liver disease
• Kidney Disease (or if you are on dialysis)
• Heart rhythm problems.

Orladeyo is not approved for use by anyone younger than 12 years old.

Pregnancy

Tell your healthcare professional if you are pregnant or planning to become pregnant as it is not known if Orladeyo can harm your unborn baby. 

Breastfeeding 

Tell your healthcare professional if you are breastfeeding or planning to breastfeed as it is not known if Orladeyo passes into breast milk. Talk to your healthcare professional about the best way to feed your baby.

Orladeyo Dosing Information

Recommended Orladeyo dosage: One capsule (150 mg) taken orally once daily with food.

Dose adjustment for ongoing GI reactions: Gastrointestinal side effects can occur in some patients. If these side effects persist a reduce dose of 110mg once daily with food may be considered.

Dose adjustment for hepatic impairment:

• No adjustment is required for mild hepatic impairment (Child-Pugh Class A)
• For Patients with moderate or severe hepatic impairment (Child-Pugh B or C)  the recommended dose is one 110 mg capsule taken orally once daily with food

What happens if I miss a dose?

• Take as soon as you remember.
• Skip the missed dose if it is almost time for your next dose.
• Do not double up on doses.

What other drugs will affect this medicine?

Orladeyo may interact with other medications, including:

• P-gp inducers – avoid use with Orladeyo.
• CYP2D6, CYP3A4, or P-gp substrates – monitor closely or dose titrate narrow therapeutic index medications that are predominantly metabolized by CYP2D6, CYP3A4 or are P-gp substrates when co-administered with Orladeyo.

What is orlistat?

Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body.

Orlistat is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. This medicine must be used together with a reduced-calorie diet and increased physical activity. Orlistat is for use only in adults that are overweight or obese.

Xenical is the prescription-strength form of orlistat. The Alli brand is available without a prescription.

Warnings

Do not take orlistat if you are pregnant.

You should not use this medicine if you have a digestive disorder (problems absorbing food). You should not use Xenical if you have gallbladder problems, or if you are pregnant. Do not use Alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Before taking this medicine

You should not use orlistat if you are allergic to it, if you have malabsorption syndrome (an inability to absorb food and nutrients properly), or if you are pregnant.

You also should not use Xenical if you have:

• gallbladder problems; or
• if you are pregnant.

Do not use Alli if:

• you are not overweight;
• you have had an organ transplant; or
• you are taking cyclosporine

To make sure orlistat is safe for you, tell your doctor if you have ever had:

• kidney stones;
• gallbladder disease;
• pancreatitis;
• thyroid disease;
• liver disease;
• kidney disease; or
• organ transplant; or
• an eating disorder (anorexia or bulimia).

Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking this medicine and tell your doctor right away if you become pregnant.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

Xenical is not approved for use by anyone younger than 12 years old. Do not give Alli to anyone under 18 years old.

How should I take orlistat?

Use orlistat exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never share orlistat with another person, especially someone with a history of eating disorders.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Orlistat is usually taken 3 times per day with each main meal that contains some fat (no more than 30% of the calories for that meal). You may take the medicine either with your meal or up to 1 hour after eating.

If you skip a meal or you eat a meal that does not contain any fat, skip your dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Orlistat is only part of a complete program of treatment that also includes diet and exercise. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Orlistat can make it harder for your body to absorb certain vitamins, and you may need to take a vitamin and mineral supplement while you are taking this medicine. Follow your doctor’s instructions about the type of supplement to use. Take the supplement at bedtime, or at least 2 hours before or after you take orlistat.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed. Throw away any unused orlistat after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid eating high-fat meals or you could have unpleasant side effects on your stomach or intestines.

If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take orlistat.

If you also take levothyroxine (such as Synthroid), do not take it within 4 hours before or 4 hours after you take orlistat.

Orlistat side effects

Get emergency medical help if you have signs of an allergic reaction to orlistat: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using orlistat and call your doctor at once if you have:

• severe stomach pain;
• severe pain in your lower back;
• blood in your urine, painful or difficult urination;
• signs of kidney problems including little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; or
• signs of liver problems including nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common orlistat side effects are caused by its fat-blocking action. These are signs that the medicine is working properly. These side effects are usually temporary and may lessen as you continue using this medicine:

• oily or fatty stools;
• oily spotting in your undergarments;
• orange or brown colored oil in your stool;
• gas and oily discharge;
• loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;
• an increased number of bowel movements; or
• stomach pain, nausea, rectal pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Dosing information

Usual Adult Dose for Obesity:

120 mg orally three times a day with each main meal containing fat. The dose may be taken during the meal or within 1 hour of completing the meal.

Usual Pediatric Dose for Obesity:

12 years or older:
120 mg orally three times a day with each main meal containing fat. The dose may be taken during the meal or within 1 hour of completing the meal.

What other drugs will affect orlistat?

Ask a doctor or pharmacist if it is safe for you to use orlistat if you are also using any of the following drugs:

• amiodarone;
• cyclosporine;
• insulin or oral diabetes medicine;
• HIV or AIDS medications;
• seizure medicine (especially if your seizures get worse while taking this medicine);
• a vitamin or mineral supplement that contains beta-carotene or vitamin E; or
• a blood thinner – warfarin, Coumadin, Jantoven.

What is Ortho Tri-Cyclen?

Ortho Tri-Cyclen is a combination birth control pill containing the female hormones ethinyl estradiol and norgestimate. These hormones prevent ovulation (the release of an egg from an ovary).

Ortho Tri-Cyclen also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ortho Tri-Cyclen is used as contraception to prevent pregnancy.

Ortho Tri-Cyclen is also used to treat moderate acne vulgaris in females who are at least 15 years old. This medicine should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Warnings

Do not use Ortho Tri-Cyclen if you are pregnant or if you have recently had a baby.

You should not use Ortho Tri-Cyclen if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take Ortho Tri-Cyclen if you smoke and are over 35 years old.

Before taking this medicine

Taking Ortho Tri-Cyclen can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use Ortho Tri-Cyclen if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take Ortho Tri-Cyclen if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (aura, numbness, vision changes), especially if you are older than 35; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

To make sure Ortho Tri-Cyclen is safe for you, tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease, underactive thyroid;
• liver or kidney disease;
• jaundice caused by pregnancy or birth control pills;
• irregular menstrual cycles; or
• fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

How should I take Ortho Tri-Cyclen?

Take Ortho Tri-Cyclen exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using Ortho Tri-Cyclen. Follow your doctor’s instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily.

Ortho Tri-Cyclen packs contain seven dark green “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need major surgery with long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Ortho Tri-Cyclen.

While taking Ortho Tri-Cyclen, you will need to visit your doctor regularly.

Store this medicine at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Ortho Tri-Cyclen for Contraception:

1 tablet orally once a day

Usual Adult Dose for Acne:

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Usual Pediatric Dose for Acne:

15 years or older: 1 tablet orally once a day

-Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no know contraindications to oral contraceptive therapy and who have achieved menarche.

What happens if I miss a dose?

Follow the instructions provided with your medicine. Missing an Ortho Tri-Cyclen pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not smoke while taking Ortho Tri-Cyclen, especially if you are older than 35 years of age.

Ortho Tri-Cyclen will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ortho Tri-Cyclen side effects

Get emergency medical help if you have signs of an allergic reaction to Ortho Tri-Cyclen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Ortho Tri-Cyclen and call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe headache, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common Ortho Tri-Cyclen side effects may include:

• stomach pain, gas, nausea, vomiting;
• breast tenderness;
• acne, darkening of facial skin;
• headache, nervousness, mood changes;
• problems with contact lenses;
• changes in weight;
• breakthrough bleeding;
• vaginal itching or discharge; or
• rash.

What is oseltamivir?

Oseltamivir is an antiviral medication that blocks the actions of influenza virus types A and B in your body.

Oseltamivir is used to treat influenza in people 2 weeks of age and older who have had flu symptoms for 2 days or less. Oseltamivir may also be given to prevent influenza in people who may have been exposed but do not yet have symptoms. This medicine will not treat the common cold.

It is dangerous to purchase oseltamivir on the Internet or outside the United States. The sale and distribution of medicines outside the U.S. does not comply with safe-use regulations of the Food and Drug Administration (FDA). These medications may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of “Tamiflu” purchased on the Internet have been found to contain cloxacillin, a type of antibiotic that can have dangerous side effects in people who are allergic to penicillin.

Warnings

Oseltamivir is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. It may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. This medicine will not treat the common cold.

Before taking this medicine, tell your doctor if you have received a nasal flu vaccine within the past 2 weeks, or if you have kidney disease, heart disease, lung disease, or any other serious disease or health problem. Also tell your doctor if you have any condition causing swelling or disorder of the brain.

Take Oseltamivir for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

Some people using this medicine have had rare side effects of sudden confusion, delirium, hallucinations, unusual behavior, or self-injury. These symptoms have occurred most often in children. It is not known whether this medicine was the exact cause of these symptoms. However, anyone using this medicine should be watched closely for signs of confusion or unusual behavior. Call a doctor at once if you or the child using this medicine has any of these symptoms.

Before taking this medicine

Oseltamivir should not be used in place of getting a yearly flu shot. The Centers for Disease Control (CDC) recommends an annual flu shot to help protect you each year from new strains of influenza virus. You can get a flu shot even while using this medicine.

You should not use oseltamivir if you are allergic to it.

Do not use oseltamivir to prevent influenza in a child younger than 3 months old. Do not use this medicine to treat influenza in a child younger than 2 weeks old unless instructed by your doctor.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• heart disease or chronic lung disease;
• a condition causing swelling or disorder of the brain;
• a weak immune system (caused by disease or by using certain medicine);
• hereditary fructose intolerance; or
• if you have used a nasal flu vaccine (FluMist) within the past 2 weeks.

It is not known whether this medicine will harm an unborn baby. However, getting sick with influenza during pregnancy can cause complications leading to birth defects, low birth weight, preterm delivery, or stillbirth. Your doctor will decide whether you should receive oseltamivir if you are pregnant.

The Centers for Disease Control and Prevention (CDC) recommends that pregnant women may receive a yearly flu vaccine to prevent influenza. Oseltamivir is not to be used in place of the yearly flu shot.

It is not known whether oseltamivir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take oseltamivir?

Take oseltamivir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Start taking this medicine as soon as possible after flu symptoms appear, such as fever, chills, muscle aches, sore throat, and runny or stuffy nose.

Take the oseltamivir capsule with a full glass of water.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Oseltamivir may be taken with food if it upsets your stomach.

To treat flu symptoms: Take oseltamivir every 12 hours for 5 days.

To prevent flu symptoms: Take oseltamivir every 24 hours for 10 days or as prescribed. Follow your doctor’s instructions.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Tell your doctor if your symptoms do not improve, or if they get worse.

Store oseltamivir capsules at room temperature away from moisture and heat.

Store liquid medicine in the refrigerator but do not freeze. Throw away any unused liquid after 17 days.

The liquid may also be stored at cool room temperature for up to 10 days

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not use a nasal flu vaccine (FluMist) within 48 hours after taking this medicine. Oseltamivir may interfere with the drug action of FluMist, making the vaccine less effective. Follow your doctor’s instructions.

Oseltamivir side effects

Get emergency medical help if you have signs of an allergic reaction to oseltamivir (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some people using oseltamivir (especially children) have had sudden unusual changes in mood or behavior. It is not certain that this medicine is the exact cause of these symptoms. Even without using oseltamivir, anyone with influenza can have neurologic or behavioral symptoms. Call your doctor right away if the person using this medicine has:

• sudden confusion;
• tremors or shaking;
• unusual behavior; or
• hallucinations (hearing or seeing things that are not there).

Common oseltamivir side effects may include:

• nausea, vomiting;
• headache; or
• pain.