Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Jinteli

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, 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.

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 HIV infection 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 Jinteli

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 ethinyl estradiol and norethindrone 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

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

• 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
• 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
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Jinteli

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 with a Dialpak® tablet dispenser. 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, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

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

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):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 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.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more 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 active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: 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.
  • 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.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

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 Jinteli

It is very important that your doctor check your progress at regular visits to make sure that 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 had given birth 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 missed 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, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, 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. 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 shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

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 (ophthalmologist) to check your eyes.

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

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

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.

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 Jinteli

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:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

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:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

What is Myfembree?

Myfembree is a prescription medicine used in premenopausal women (before “change of life” or menopause) to control heavy menstrual bleeding due to uterine fibroids.

Myfembree is also used in premenopausal women to manage moderate to severe pain associated with endometriosis. 

Myfembree contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

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

Important information

Myfembree may cause serious side effects, including:

Cardiovascular conditions: Myfembree may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age, smoke, and have uncontrolled high blood pressure. Stop treatment and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:

• leg pain or swelling that will not go away
• sudden shortness of breath
• double vision, bulging of the eyes, sudden blindness, partial or complete
• pain or pressure in your chest, arm, or jaw
• sudden, severe headache unlike your usual headaches
• weakness or numbness in an arm or leg, or trouble speaking

Bone loss (decreased bone mineral density): While you are taking Myfembree, your estrogen levels may be low. Low estrogen levels can lead to bone mineral density loss.

• If you have bone loss on Myfembree, your bone density may improve after you stop taking Myfembree, but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, you should not take Myfembree for more than 24 months.
• Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start treatment and periodically after you start.
•  Your healthcare provider may advise you to take vitamin D and/or calcium supplements as part of a healthy lifestyle that promotes bone health. If you are also advised to take iron supplements, they should be taken at least two hours apart from your vitamin D or calcium supplements.

Effects on pregnancy: Do not take Myfembree if you are trying to become pregnant or are pregnant. It may increase the risk of early pregnancy loss.

• If you think you are pregnant, stop treatment right away and call your healthcare provider. If you become pregnant during treatment, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-(855) 428-0707.
• Myfembree can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain and nausea.
• Myfembree does not prevent pregnancy. You will need to use effective methods of birth control during treatment and for 1 week after you stop treatment. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
• Do not take hormonal birth control such as birth control pills, because they may increase your side effects and Myfembree may not work as well.

Talk to your healthcare provider about which birth control to use during treatment.
Your healthcare provider may change the birth control you were on before you start treatment.

Who should not take Myfembree?

You should not take Myfembree if you have or have had:

• blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
• stroke or heart attack
• a problem that makes your blood clot more than normal
• blood circulation disorders
• certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• high blood pressure not well controlled by medicine
• diabetes with kidney, eye, nerve, or blood vessel damage
• certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision or migraine headaches if you are over age 35
• breast cancer or any cancer that is sensitive to female hormones
• osteoporosis
• vaginal bleeding that has not been diagnosed. Your healthcare provider should check any unexplained vaginal bleeding to find out the cause.
• liver problems including liver disease.

You should not take Myfembree if you:

• smoke and are over 35 years old
• have had a serious allergic reaction with symptoms that included swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, redness, or swelling or an allergic reaction to relugolix, estradiol, norethindrone or any of the ingredients. See the end of this page for a complete list of ingredients.

Before taking Myfembree

Before you start treatment, tell your healthcare provider about all of your medical conditions including if you have or have had:

• broken bones or other conditions that may cause bone problems.
• depression, mood swings, or suicidal thoughts or behavior.
• yellowing of the skin or eyes (jaundice) or jaundice caused by pregnancy (cholestasis of pregnancy).

Tell your healthcare provider if you:

• are scheduled for surgery or will be on bed rest. Myfembree may increase your risk of blood clots after surgery. Your healthcare provider may advise you to stop taking Myfembree before you have surgery. Talk to your healthcare provider about when to stop Myfembree before surgery and when to restart.
• are pregnant or think you may be pregnant or just had a baby.
• are breastfeeding. Myfembree may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Myfembree.

Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
Women on thyroid or cortisol replacement therapy may need increased doses of the hormone.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Myfembree?

• Take Myfembree tablets exactly as your healthcare provider tells you to take it.
• Take Myfembree 1 time each day at about the same time with or without food.
• If you have to take oral P-gp inhibitors, take Myfembree first and wait at least 6 hours before taking the P-gp inhibitor. Ask your healthcare provider if you are not sure if you are taking this type of medicine.
• Your healthcare provider may give you a pregnancy test before you start treatment.
• You should begin Myfembree as soon as possible after your period begins, but no later than 7 days after your period has started. If you start on another day, your period may become heavy or irregular for the first month after starting treatment, but bleeding should decrease after this time.
• If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
• If you miss a dose, take the missed dose as soon as you remember on that day, and then take Myfembree at the usual time the next day.
• Do not take 2 doses at once to make up for the missed dose. If you do not remember until you are due for Myfembree on the next day, do not make up for the missed dose.

Dosing information

Usual Adult Dose for Uterine Fibroids

– One tablet orally once daily. Each tablet contains relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

Use: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Usual Adult Dose for Endometriosis

– One tablet orally once daily. Each tablet contains relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

Use: management of moderate to severe pain associated with endometriosis in premenopausal women.

Myfembree side effects

Myfembree may cause serious side effects including:

See Important information.

Suicidal thoughts, suicidal behavior, and worsening of mood. Call your healthcare provider or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• other unusual changes in behavior or mood

Pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.

Abnormal liver tests. Call your healthcare provider right away if you have any of these signs and symptoms of liver problems:

• jaundice
• dark amber-colored urine
• feeling tired (fatigue or exhaustion)
• nausea and vomiting
• generalized swelling
• right upper stomach area (abdomen) pain
• bruising easily

Gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy.

High blood pressure. See your healthcare provider to check your blood pressure regularly.

Uterine fibroid prolapse or expulsion. Fibroids can come out completely or partially through the vagina. Call your healthcare provider right away if you have increased bleeding from the vagina, which can be serious, or cramping, while taking Myfembree.

Hair loss (alopecia). Hair loss and hair thinning can happen while taking Myfembree. It is not known if this hair loss or hair thinning stops after you stop treatment, or is reversible. Talk to your healthcare provider if this is a concern for you.

Increases in the blood sugar, cholesterol and fat (triglycerides) levels in your blood.

Changes in laboratory tests including thyroid, steroid, hormone, cholesterol, and blood clotting tests.

The most common side effects in women who have heavy bleeding with uterine fibroids include:

• hot flushes
• increased sweating
• night sweats
• abnormal vaginal bleeding (bleeding that lasts too long, is too much, or is unexpected)
• hair loss or hair thinning
• decreased interest in sex

The most common side effects in women in women who have moderate to severe pain with endometriosis include:

• headache
• hot flushes, sweating, or night sweats
• mood changes including worsening depression
• abnormal vaginal bleeding (bleeding that lasts too long, that is too much, or is unexpected)
• nausea
• toothache
• back pain
• decreased interest in sex
• joint pain
• tiredness
• dizziness 

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;