What is raloxifene?

Raloxifene is used to treat osteoporosis in postmenopausal women.

Raloxifene is not for use in men.

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

Raloxifene 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.

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

• swelling, tenderness, or other changes in your breasts;
• signs of a stroke–sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;
• signs of a blood clot in the lung–chest pain, trouble breathing, coughing up blood; or
• signs of a blood clot deep in the body–swelling, warmth, or redness in an arm or leg.

Common side effects of raloxifene may include:

• hot flashes;
• leg cramps;
• swelling in your hands, feet, or ankles;
• joint pain;
• flu symptoms; or
• increased sweating.

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

Warnings

raloxifene may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

Raloxifene can also increase your risk of a stroke, which can be fatal. This risk is highest if you have certain risk factors (such as smoking, having heart problems or high blood pressure, or if you have ever had a heart attack or a stroke).

Although this medicine is for use only in postmenopausal women, you should not take raloxifene if you are pregnant or breastfeeding.

Before taking this medicine

This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.

Do not breastfeed while taking raloxifene.

Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:

• heart problems, irregular heartbeats;
• a heart attack or stroke, including “mini-stroke”;
• high blood pressure;
• cancer; or
• if you smoke.

Tell your doctor if you have ever had:

• a blood clot;
• high triglycerides caused by using estrogen;
• liver or kidney disease;
• endometriosis;
• abnormal vaginal bleeding; or
• if you have not gone through menopause.

How should I take raloxifene?

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

Take the medicine at the same time each day, with or without food.

If you need major surgery or will be on long-term bed rest, you will need to stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take raloxifene.

Raloxifene is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor’s instructions very closely.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Store at room temperature away from moisture and heat.

Raloxifene dosing information

Usual Adult Dose for Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Breast Cancer:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

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.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking raloxifene?

If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

What is rabeprazole?

Rabeprazole is used short-term to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.

Rabeprazole is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Rabeprazole is also used in adults to promote healing of duodenal ulcers or erosive esophagitis (damage to your esophagus caused by stomach acid).

Rabeprazole may also be given with an antibiotic to prevent duodenal ulcer caused by infection with Helicobacter pylori (H. pylori).

Rabeprazole is not for immediate relief of heartburn symptoms.

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

Rabeprazole 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.

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

• severe stomach pain, diarrhea that is watery or bloody;
• sudden pain or trouble moving your hip, wrist, or back;
• seizure (convulsions);
• kidney problems–fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, swelling, rapid weight gain;
• new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight;
• low magnesium–dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• signs of bleeding (if you also take warfarin)–headaches, dizziness, weakness; pain or swelling; bruising, unusual bleeding (nosebleeds, bleeding gums); red or pink urine; heavy menstrual flow; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or any bleeding that will not stop.

Taking rabeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use rabeprazole 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 rabeprazole may include:

• infection;
• pain;
• sore throat;
• headache;
• nausea, vomiting;
• gas, diarrhea, constipation; or
• stomach pain.

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

Warnings

Rabeprazole 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.

Rabeprazole 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 rabeprazole 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 anxious or light-headed.

You should not use this medicine if you are allergic to rabeprazole or:

• if you also take any medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey);
• if you had breathing problems, kidney problems, or a severe allergic reaction after taking rabeprazole in the past; or
• if you are also allergic to medicines like rabeprazole, such as esomeprazole, lansoprazole, omeprazole, pantoprazole , Nexium, Prevacid, Prilosec, Protonix, and others.

Tell your doctor if you have ever had:

• liver disease;
• osteoporosis or low bone mineral density (osteopenia);
• lupus (an autoimmune disorder); or
• low levels of magnesium in your blood.

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.

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice. Certain forms and strengths of rabeprazole should not be given to a child younger than 12 years old.

How should I take rabeprazole?

Rabeprazole is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Rabeprazole is for short-term use only, usually 4 to 8 weeks. Your doctor may recommend a second course of treatment if you need additional healing time.

AcipHex Sprinkle should not be given to a child younger than 1 year old.

Take rabeprazole with a full glass of water.

If you take rabeprazole to treat duodenal ulcers, take the medicine after a meal. If you take rabeprazole to prevent ulcers caused by Helicobacter pylori, take the medicine with food. If you take rabeprazole for any other condition, you may take the medicine with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

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

Do not swallow a delayed-release capsule (AcipHex Sprinkle) whole. Open it and sprinkle the medicine into a spoonful of soft food such as applesauce, yogurt, or baby food made from fruit or vegetable. You may also mix the medicine with apple juice, Pedialyte, or infant formula. Swallow the mixture right away without chewing. Do not save it for later use.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using rabeprazole.

Some conditions are treated with a combination of rabeprazole and antibiotics. Use all medications as directed.

Take your medicines for the full prescribed length of time, even if your symptoms quickly improve.

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

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 should I avoid while taking rabeprazole?

rabeprazole 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.

What other drugs will affect rabeprazole?

Tell your doctor about all your current medicines. Many drugs can affect rabeprazole, especially:

• an antibiotic such as clarithromycin or amoxicillin;
• digoxin;
• a diuretic or “water pill”;
• methotrexate; or
• warfarin (Coumadin, Jantoven).

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your “sleep-wake cycle.”

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

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

Ramelteon side effects

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using ramelteon have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

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

• unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
• a missed menstrual period;
• nipple discharge; or
• loss of interest in sex.

Common side effects of ramelteon may include:

• drowsiness, tired feeling;
• dizziness;
• nausea; or
• worsening sleep problems.

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

Warnings

You should not use ramelteon if you are also taking fluvoxamine, or if you have ever had a severe allergic reaction to ramelteon.

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Before taking this medicine

Ramelteon will make you fall asleep. Never take ramelteon during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use ramelteon if you are allergic to it, or if:

• you have severe liver disease; or
• you also take fluvoxamine.

Tell your doctor if you have ever had:

• liver disease;
• breathing problems;
• sleep apnea (breathing stops while you are asleep); or
• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed within 25 hours after using ramelteon. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

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

How should I take ramelteon?

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

Take ramelteon 30 minutes before your normal bedtime.

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

Ramelteon should not be taken with or after a high-fat meal. This will make it harder for your body to absorb the medication.

Call your doctor if your symptoms do not improve after 7 to 10 days of using ramelteon.

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

Ramelteon dosing information

Usual Adult Dose for Insomnia:

8 mg orally within 30 minutes of going to bed

Maximum Dose: 8 mg per day

Comments: This drug should not be taken with or immediately after a high-fat meal.

Use: Treatment of insomnia characterized by difficulty with sleep onset

What happens if I miss a dose?

Since ramelteon is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medication if you do not have 7 to 8 hours to sleep before being active again.

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 ramelteon?

Do not drink alcohol with ramelteon.

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

What is ramipril?

Ramipril is used to treat high blood pressure (hypertension) or congestive heart failure to reduce the risk of cardiovascular events, strokes, and myocardial infarctions. Ramipril is an ACE inhibitor. ACE stands for angiotensin-converting enzyme.

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

Warnings

Do not use ramipril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use ramipril if you have ever had angioedema. Do not take this medicine within 36 hours before or after taking medicine that contains sacubatril (such as Entresto).

If you have diabetes, do not use ramipril together with any medication that contains aliskiren (such as Tekturna or Tekamlo).

Before taking this medicine

You should not use ramipril if you are allergic to it, or if:

• you have a history of angioedema;
• you recently took a heart medicine called sacubatril; or
• if you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, or trandolapril.

Do not take ramipril within 36 hours before or after taking medicine that contains sacubatril (such as Entresto).

If you have diabetes, do not use ramipril together with any medication that contains aliskiren (such as Tekturna or Tekamlo).

You may also need to avoid taking ramipril with aliskiren if you have kidney disease.

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

• kidney disease (or if you are on dialysis);
• liver disease;
• a connective tissue disease such as Marfan syndrome, Sjogren’s syndrome, lupus, scleroderma, or rheumatoid arthritis; or
• if you are also taking telmisartan (Micardis).

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Ramipril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

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

How should I take ramipril?

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

Ramipril can be taken with or without food.

Swallow the tablet whole.

You may open the capsule and sprinkle the medicine into a half-cup (4 ounces) of water, apple juice, or applesauce to make swallowing easier. Swallow without chewing. You may store the mixture for up to 24 hours at room temperature, or up to 48 hours in a refrigerator.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking ramipril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often, and you may need frequent blood tests to check your potassium levels.

Drink plenty of water each day while you are taking this medication.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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

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 .

What should I avoid?

Do not use salt substitutes or potassium supplements while taking ramipril, unless your doctor has told you to.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of ramipril.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Ramipril side effects

Get emergency medical help if you have any signs of an allergic reaction to ramipril: hives; severe stomach pain; 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;
• jaundice (yellowing of your skin or eyes);
• little or no urination;
• fever, chills, sore throat, cold or flu symptoms; or
• high potassium – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common ramipril side effects may include:

• headache;
• cough; or
• dizziness, weakness, tired feeling.

What is Ranexa?

Ranexa (ranolazine) belongs to a class of medications called anti-anginals. The exact way that ranolazine works is not known at this time.

Ranexa is used in adults to treat chronic angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen).

Ranexa is used alone or with other medications. This medicine is not for use during an acute (emergency) attack of angina.

Warnings

You should not take Ranexa if you have cirrhosis of the liver.

Serious drug interactions can occur when certain medicines are used together with Ranexa. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Ranexa is not for use during an acute (emergency) attack of chest pain. Continue using any other medicines prescribed by your doctor (such as nitroglycerin) to treat acute chest pain.

Before you take Ranexa, tell your doctor about all of your medical conditions, especially if you have a personal or family history of Long QT syndrome.

Chronic angina is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Before taking this medicine

You should not take Ranexa if you are allergic to ranolazine, or if you have:

• cirrhosis of the liver.

Some drugs should not be used with Ranexa. Your treatment plan may change if you also use:

• clarithromycin;
• nefazodone;
• St. John’s wort;
• antifungal medicine – itraconazole, ketoconazole;
• HIV or AIDS medicine – indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir;
• seizure medicine – carbamazepine, phenobarbital, phenytoin; or
• tuberculosis medicine – rifabutin, rifampin, rifapentine.

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

• long QT syndrome (in you or a family member);
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Ranexa?

Take Ranexa 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.

You may take Ranexa tablets with or without food.

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

Chronic angina is often treated with a combination of drugs. Do not change your dose or dosing schedule without your doctor’s advice.

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

You may need medical tests to check your heart and kidney function.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Angina Pectoris:

500 mg orally twice a day; increase to 1000 mg orally twice a day as needed

Maximum dose: 1000 mg orally twice a day

Use: Treatment of chronic angina

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 .

Overdose symptoms include nausea, vomiting, numbness or tingling, low blood pressure, dizziness, irregular heartbeats, trouble speaking, double vision, hallucinations, confusion, uncontrolled shaking, or fainting.

What should I avoid while taking Ranexa?

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

Grapefruit may interact with ranolazine and lead to unwanted side effects. Avoid the use of grapefruit products.

Ranexa side effects

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

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

• a light-headed feeling;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
• kidney problems – swelling, urinating less, feeling tired or short of breath.

Common Ranexa side effects may include:

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

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 Ranexa?

Tell your doctor about all your current medicines. Many drugs can affect ranolazine, especially:

• any other medicine to treat heart disease;
• an antibiotic or antifungal medicine;
• oral diabetes medicine;
• medicine to prevent organ transplant rejection;
• medicine to treat a mental illness; or
• medicine to treat or prevent nausea and vomiting caused by chemotherapy or radiation.

What is ranitidine?

Ranitidine was withdrawn from the market in the United States in April 2020.

Ranitidine belongs to a group of drugs called histamine-2 blockers. It works by reducing the amount of acid your stomach produces.

Ranitidine has been used to treat and prevent ulcers in the stomach and intestines. It also was used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome..

Ranitidine was also used to treat gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

A cancer-causing impurity found in many ranitidine medications may increase to unacceptable levels over time and when ranitidine is stored at high temperatures. As a result, the FDA has asked all makers of ranitidine to withdraw this medicine from the market in the United States.

Warnings

Ranitidine has been withdrawn from the market in the United States. Some of the contents of this leaflet are preserved for historical purposes only.

Using ranitidine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

Do not use this medication if you are allergic to ranitidine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Ranitidine granules and effervescent tablets must be dissolved in water before you take them. Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it. Avoid drinking alcohol. It can increase the risk of damage to your stomach. It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Before taking this medicine

If you have been taking prescription-strength ranitidine: Before you stop taking the medicine, ask your doctor about safer treatment options.

If you have been taking over-the-counter (OTC) ranitidine: Stop taking the medicine, and ask your doctor or pharmacist about other approved OTC stomach acid reducers.

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 anxious or light-headed.

Before using any OTC medicine to reduce stomach acid, ask a doctor or pharmacist if the medicine is safe for you if you have other medical conditions or allergies.

Ask a doctor before using any OTC stomach acid medicine if you are pregnant or breastfeeding.

How should I take ranitidine?

Because ranitidine has been withdrawn from the market in the U.S., some of the contents of this leaflet are intended for historical purposes only.

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

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 8 weeks before your ulcer heals. Keep using your medications as directed and call your doctor if your symptoms do not improve after 6 weeks.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it.

Store at room temperature away from moisture, heat, and light.

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 .

Overdose symptoms may include lack of coordination, feeling light-headed, or fainting.

What to avoid

You should not stop taking prescription-strength ranitidine until you ask your doctor to prescribe a different medication. Talk with doctor as soon as possible about how best to treat your condition.

Avoid drinking alcohol. It can increase the risk of damage to your stomach.

Ranitidine side effects

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

Stop using this medicine and call your doctor at once if you have:

• stomach pain, loss of appetite;
• dark urine, jaundice (yellowing of the skin or eyes);
• fever, chills, cough with mucus, chest pain, feeling short of breath;
• fast or slow heart rate;
• easy bruising or bleeding; or
• problems with your skin or hair.

Common ranitidine side effects may include:

• nausea, vomiting, stomach pain; or
• diarrhea, constipation.

What is ranolazine?

Ranolazine is used in adults to treat chronic angina (chest pain). Ranolazine is not for use during an acute (emergency) attack of angina.

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

Ranolazine 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.

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

• a light-headed feeling;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
• kidney problems–swelling, urinating less, feeling tired or short of breath.

Common side effects of ranolazine may include:

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

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

Warnings

You should not take ranolazine if you have cirrhosis of the liver.

Tell your doctor about all your other medicines. Some drugs should not be used with ranolazine.

Before taking this medicine

You should not take ranolazine if you are allergic to it, or if you have:

• cirrhosis of the liver.

Some drugs should not be used with ranolazine. Your treatment plan may change if you also use:

• clarithromycin;
• nefazodone;
• St. John’s wort;
• antifungal medicine–itraconazole, ketoconazole;
• HIV or AIDS medicine–indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir;
• seizure medicine–carbamazepine, phenobarbital, phenytoin; or
• tuberculosis medicine–rifabutin, rifampin, rifapentine.

Tell your doctor if you have ever had:

• long QT syndrome (in you or a family member);
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take ranolazine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take ranolazine tablets with or without food.

Open the pack of ranolazine granules and mix the medicine with a tablespoon of soft food such as applesauce or yogurt. Swallow the mixture right away without crushing or chewing.

Ranolazine granules can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

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

Chronic angina is often treated with a combination of drugs. Do not change your dose or dosing schedule without your doctor’s advice.

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

You may need medical tests to check your heart and kidney function.

Store at room temperature away from moisture and heat.

Ranolazine dosing information

Usual Adult Dose for Angina Pectoris:

500 mg orally twice a day; increase to 1000 mg orally twice a day as needed

Maximum dose: 1000 mg orally twice a day

Use: Treatment of chronic angina

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 .

Overdose symptoms include nausea, vomiting, numbness or tingling, low blood pressure, dizziness, irregular heartbeats, trouble speaking, double vision, hallucinations, confusion, uncontrolled shaking, or fainting.

What should I avoid while taking ranolazine?

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

Avoid drinking alcohol. Drinking alcohol with ranolazine granules can cause side effects.

Grapefruit may interact with ranolazine and lead to unwanted side effects. Avoid the use of grapefruit products.

What other drugs will affect ranolazine?

Tell your doctor about all your current medicines. Many drugs can affect ranolazine, especially:

medicine to treat or prevent nausea and vomiting caused by chemotherapy or radiation.

any other medicine to treat heart disease;

an antibiotic or antifungal medicine;

oral diabetes medicine;

medicine to prevent organ transplant rejection;

medicine to treat a mental illness; or

What is Rapamune?

Rapamune weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Rapamune is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body’s immune system recognizes the new organ as a “foreign” threat and attacks it. Rapamune is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids.

Rapamune is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (LAM). LAM affects predominantly women of childbearing age. This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

Warnings

You should not use Rapamune if you have ever had a lung transplant or liver transplant.

Rapamune may cause your body to overproduce white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Call your doctor right away if you have: fever, flu symptoms, burning when you urinate, a new skin lesion, any change in your mental state, decreased vision, weakness on one side of your body, problems with speech or walking, or pain around your transplant.

Before taking this medicine

You should not use Rapamune if you are allergic to sirolimus, or if you have ever had a lung transplant or liver transplant.

Talk with your doctor about the risks and benefits of using this medicine. Rapamune can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

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

• high cholesterol or triglycerides;
• cytomegalovirus (CMV);
• liver disease; or
• a family history of skin cancer (melanoma).

Do not use Rapamune if you are pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine, and for at least 12 weeks after your last dose.

You should not breast-feed while using this medicine.

Rapamune should not be given to a child younger than 13 years old.

How should I take Rapamune?

Take Rapamune 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.

Rapamune is usually taken once a day. If you also take cyclosporine, take it at least 4 hours before you take this medicine.

You may take Rapamune with or without food, but take it the same way every time.

Do not crush, chew, or break a Rapamune tablet. Tell your doctor if you have trouble swallowing the tablet whole.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rapamune oral liquid must be mixed only with water or orange juice, no other juices or liquids. Measure the liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Sirolimus can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests. Your dosing schedule may be delayed based on the results of these tests.

You should not stop using Rapamune without your doctor’s advice. Stopping suddenly could make your condition worse.

Store the tablets at room temperature, away from heat, moisture, and light.

Store the oral liquid in the refrigerator. Do not freeze. You may notice a slight haze to the liquid. This haze should disappear when the liquid reaches room temperature.

If you are using Rapamune oral liquid with a disposable syringe, you may store a loaded syringe in the carrying case provided. Keep the case at room temperature and use the medicine within 24 hours. Use a disposable syringe only once and then throw it away.

Dosing information

Usual Adult Dose of Rapamune for Organ Transplant — Rejection Prophylaxis:

FOR PATIENTS AT LOW TO MODERATE IMMUNOLOGIC RISK:
Dosing by body weight:
-Less than 40 kg:
Loading dose: 3 mg/m2 on day 1
Maintenance: 1 mg/m2 once daily
-Greater than or equal to 40 kg:
Loading dose: 6 mg orally on day 1
Maintenance: 2 mg orally once daily

IN PATIENTS AT HIGH IMMUNOLOGIC RISK (defined as Black transplant recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high-panel reactive antibodies [PRA; peak PRA level greater than 80%]):
-For patients receiving sirolimus with cyclosporine:
Loading Dose: Up to 15 mg on day one post-transplantation
Maintenance Dose: Beginning on day 2, an initial maintenance dose of 5 mg/day should be given. A trough level should be obtained between days 5 and 7, and the daily dose of sirolimus should be adjusted thereafter.
-Antibody induction therapy may be used.

Comments:
-It is recommended that this sirolimus be used in a regimen with cyclosporine and corticosteroids.
-Sirolimus should be taken consistently with or without food.
-Once the sirolimus maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring.

MAINTENANCE THERAPY AFTER WITHDRAWAL OF CYCLOSPORINE:
-Cyclosporine withdrawal is not recommended in high-immunological risk patients. Following 2 to 4 months of combined therapy, withdrawal of cyclosporine may be considered in low-to-moderate risk patients. Cyclosporine should be discontinued over 4 to 8 weeks, and a necessary increase in the dosage of sirolimus (up to 4-fold) should be anticipated due to removal of metabolic inhibition by cyclosporine and to maintain adequate immunosuppressive effects. -Dose-adjusted trough target concentrations are typically 16 to 24 ng/mL for the first year post-transplant and 12 to 20 ng/mL thereafter (measured by chromatographic methodology).

Usual Adult Dose of Rapamune for Pulmonary Lymphangioleiomyomatosis:

-Initial dose: 2 mg/day
-Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 and 15 ng/mL.

Comment:
-This drug should be taken consistently with or without food.

Usual Pediatric Dose of Rapamune for Organ Transplant — Rejection Prophylaxis:

FOR PATIENTS AT LOW TO MODERATE IMMUNOLOGIC RISK:
Greater than or equal to 13 years of age:
Dosing by body weight:
-Less than 40 kg:
Loading dose: 3 mg/m2 on day 1
Maintenance: 1 mg/m2 once daily
-Greater than or equal to 40 kg:
Loading dose: 6 mg orally on day 1
Maintenance: 2 mg orally once daily

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 Rapamune?

Avoid exposure to sunlight or tanning beds. Rapamune may increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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

Avoid getting Rapamune oral liquid on your skin. Wash the skin with soap and water if this happens. If the medicine gets into your eyes, rinse them with plain water.

Grapefruit may interact with sirolimus and lead to unwanted side effects. Avoid the use of grapefruit and grapefruit juice while taking Rapamune.

Do not receive a “live” vaccine while using Rapamune. 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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Rapamune side effects

Rapamune may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Get emergency medical help if you have signs of an allergic reaction to Rapamune: hives, rash, or peeling skin; wheezing, difficulty breathing, chest pain or tightness; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• redness, oozing, or slow healing of a skin wound;
• a new skin lesion, or a mole that has changed in size or color;
• unusual bleeding or bruising;
• sudden chest pain or discomfort, cough, feeling short of breath;
• tenderness around the transplanted kidney;
• signs of infection – fever, chills, painful mouth sores, skin sores, cold or flu symptoms, pain or burning when you urinate; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Rapamune side effects may include:

• fever, cold symptoms such as stuffy nose, sneezing, sore throat;
• mouth sores;
• nausea, stomach pain, diarrhea;
• headache, muscle aches;
• chest pain;
• dizziness; or
• acne.

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 Rapamune?

Tell your doctor about all your current medicines. Many drugs can interact with Rapamune, especially:

• bromocriptine (Cycloset, Parlodel);
• cyclosporine;
• danazol;
• St. John’s wort;
• tacrolimus;
• cholesterol-lowering medication;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat HIV or hepatitis C;
• heart or blood pressure medication;
• medicine to reduce stomach acid or treat an ulcer; or
• seizure medicine.

What is ravulizumab-cwvz?

Ravulizumab-cwvz is a prescription medication used to treat myasthenia gravis (gMG), hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and neuromyelitis optica spectrum disorder (NMOSD) in certain patients. Ravulizumab helps regulate the immune system to prevent it from harming cells, which improves symptoms of these conditions.

Ravulizumab is given as an intravenous (IV) infusion by a healthcare provider. After the initial loading doses, ravulizumab is administered as a maintenance dose every 4 to 8 weeks

Ravulizumab brand name is Ultomiris by Alexion Pharmaceuticals, Inc.

Ravulizumab FDA approval was granted on December 21, 2018, for paroxysmal nocturnal hemoglobinuria. Since the Ravulizumab FDA approval for myasthenia gravis (general) was granted and several other conditions.

What is ravulizumab used for?

Ravulizumab FDA-approved indications are:

• generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive
• paroxysmal nocturnal hemoglobinuria (PNH) in adults and children aged one month and older
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and children aged one month and older, with (does not include Shiga toxin E. coli-related hemolytic uremic syndrome [STEC-HUS])
• neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

​​How does ravulizumab work?

Ravulizumab mechanism of action is as a monoclonal antibody complement inhibitor (C5).

Ravulizumab is a monoclonal antibody that blocks a part of the immune system called the complement system. It specifically targets and inhibits the C5 protein, which plays a key role in immune responses. Ravulizumab binds to the C5 protein and prevents it from being activated. This stops the immune system from mistakenly attacking healthy cells, which helps reduce symptoms and prevent disease progression.

Monoclonal antibodies are lab-made proteins designed to attach to specific targets, ravulizumab targets C5. The precise way Ultomiris infusion works is unknown, but it is thought to be due to a reduction or inhibition of C5b-9 deposition. 

Ravulizumab Clinical Trial Results

Improvement in Myasthenia Gravis (gMG) Symptoms

Ravulizumab has shown to reduce symptoms of generalized myasthenia gravis, as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. This scale ranges from 0 to 24, with higher scores indicating more severe impairment.

Key Findings from Clinical Trial ALXN1210-MG-306 (NCT03920293)

At 26 weeks, patients treated with ravulizumab showed significant improvement:

• 30% of patients experienced at least a 5-point improvement in MG-ADL (vs. 11.3% in placebo)
• 56.7% of patients had at least a 3-point improvement in MG-ADL (vs. 34.1% in placebo)
• The least squares (LS) mean MG-ADL score improved by -3.1 (vs. -1.4 in placebo).

Additional Clinical Trial Data

Clinical trial results of ravulizumab cwvz in hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and neuromyelitis optica spectrum disorder (NMOSD) are available in the Ravulizumab Package Insert – Clinical Studies.

Ravulizumab side effects

Common ravulizumab side effects

Common side effects of ravulizumab in gMG may include:

• Diarrhea (15%)
• high blood pressure (14%)
• Stomach pain (6%)
• Upper respiratory tract infection (14%)
• Urinary tract infection (6%)
• Back Pain (8%)
• Dizziness (9%).

These side effects occurred in 5% or more of generalized myasthenia gravis patients treated with ravulizumab in the Clinical Trial ALXN1210-MG-306.

Side effects vary depending on the condition being treated and the dose given.

Serious ravulizumab side effects

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

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed or if you have chest pain, trouble breathing, or swelling in your face.

Call your doctor right away if you have signs of infection such as:

• muscle pain with flu-like symptoms;
• fever and a rash;
• fever and a headache;
• headache and stiffness in your neck or back;
• headache and nausea or vomiting;
• confusion; or
• your eyes may be more sensitive to light.

Call your doctor at once if you have symptoms of gonorrhea, such as:

• pain or burning when you urinate;
• pain or swelling of the genital or rectal area;
• unusual vaginal bleeding; or
• foul discharge from the penis or vagina.

If you stop using this medicine, tell your doctor if you have any new or worsening symptoms, such as tiredness, confusion, stomach pain, chest pain, trouble breathing or swallowing, trouble having an erection (in men), blood in your urine, a seizure, or loss of consciousness.

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

Ravulizumab for Myasthenia Gravis

Understanding Myasthenia Gravis

Myasthenia gravis (MG) is a neuromuscular disorder caused by disrupted nerve-to-muscle communication at the neuromuscular junction. This occurs when the immune system attacks healthy cells or proteins needed for normal function, which prevents proper muscle activation.

If myasthenia gravis is AChR antibody-positive, the condition is specifically caused by antibodies targeting acetylcholine receptors.

How Ravulizumab Works for Myasthenia Gravis

Ravulizumab is a complement inhibitor that blocks complement, part of the immune system, responsible for damaging the neuromuscular junction. By reducing this immune attack, Ravulizumab helps improve muscle function and symptoms in people with myasthenia gravis.

Ravulizumab REMS Program (Ultomiris REMS)

Due to the risk of serious meningococcal infections, Ravulizumab is only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program known as Ultomiris REMS. This program ensures patient safety by reducing the risk of life-threatening infections.

Steps Required Before Starting Ravulizumab (Ultomiris REMS Program)

Before receiving Ravulizumab, your doctor must:

• Enroll you in the REMS program.
• Explain the risks of meningococcal infections.
• Provide information on early symptoms of infection and the need for immediate medical attention.
• Confirm meningococcal vaccination and, if needed, provide preventive antibiotics if treatment must start before full vaccination.
• Give you a Patient Safety Card outlining the risk of infection.

 Important: Meningococcal vaccines do not prevent all infections. Seek emergency medical care if you experience any of the following symptoms:

Signs of a Serious Meningococcal Infection

• High fever or fever with rapid heart rate
• Severe headache with fever
• Confusion or disorientation
• Muscle aches with flu-like symptoms
• Fever with a rash
• Headache with nausea or vomiting
• Stiff neck or back
• Light sensitivity (photosensitivity)

Warnings

Ravulizumab infusion affects your immune system. You may get infections more easily, even serious or fatal infections such as meningitis. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or if your eyes are more sensitive to light.

You will need to receive certain vaccinations, including vaccinations to protect against meningococcal disease, at least 2 weeks before you start using ravulizumab unless the risks of delaying ravulizumab outweigh the risks of a serious infection.

Ravulizumab comes with a Patient Safety Card listing symptoms of meningococcal infection. Keep this card with you at all times while using ravulizumab and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using this medicine.

Some people may have an increased risk of gonorrhea (a sexually transmitted disease) while using this medicine. Talk with your doctor about safe ways to keep from getting an infection during sex.

This medicine should not be started in patients with unresolved serious Neisseria meningitidis infection.

Before taking this medicine

Before you receive ravulizumab infusion, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to ravulizumab or Ultomiris
• have a meningococcal infection (such as meningitis or sepsis), or if you are not currently vaccinated against meningitis (unless the risks of delaying treatment outweigh the risks of developing meningitis). You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Ultomiris. 
• If your child is treated with this medicine, make sure he or she is vaccinated against pneumonia and influenza type B (Hib). If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of Ultomiris treatment.
• have recently had any symptoms of an infection (fever, chills, or flu-like symptoms) or recently have had meningitis
• are pregnant or intend to become pregnant
• are breastfeeding or intend to breastfeed.

Ravulizumab infusion is only approved for patients 1 month and older for PNH and aHUS. For other indications (gMG and NMOSD) it is only approved for adults. Subcutaneous administration of Ultomiris has not been evaluated and is not approved for use in children.

Pregnancy

It is not known if ravulizumab will harm your unborn baby. Tell your doctor if you are pregnant. It is not known whether ravulizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.

Breastfeeding

It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose.

How is ravulizumab administered?

Intravenous (IV) infusion by a healthcare provider

Ravulizumab is given as an intravenous (IV) infusion by a healthcare professional.

• The first two infusions are usually 2 weeks apart, followed by maintenance infusions every 4 to 8 weeks.
• The infusion time ranges from 0.4 to 1.4 hours, depending on body weight and dosage.
• After each infusion, patients are monitored for at least 1 hour for any signs of an allergic reaction.

Dosage & weight considerations

• Dosages are weight-based, meaning your dose may change if you gain or lose weight.
• If switching from eculizumab (Soliris), you must wait 2 weeks after your last eculizumab dose before starting Ravulizumab.

Important safety information

Infection risks and monitoring

• Increased risk of infections, you may get infections more easily, including serious or fatal infections. Regular medical tests are required.
• The Patient Safety Card and carry it with you at all times while on Ravulizumab and for at least 8 months after the last dose.
• Infection risk may continue for several months after stopping treatment.

Risk of gonorrhea (sexually transmitted infection)

• Some patients may have a higher risk of gonorrhea.
• Talk to your doctor about safe practices to prevent infection.

Long-lasting effects after stopping treatment

• For Paroxysmal Nocturnal Hemoglobinuria (PNH): Monitoring is needed for at least 16 weeks after stopping treatment.
• For Atypical Hemolytic Uremic Syndrome (aHUS): Patients should be monitored for at least 12 months after stopping ravulizumab.

Ravulizumab dosage

Dosing is based on weight, and whether it’s a loading or maintenance dose:

• Patients 5 kg – 20 kg: Maintenance dose every 4 weeks.
• Patients 20 kg – 100+ kg: Maintenance dose every 8 weeks.

See, below for detailed “Detailed Ultomiris dosage information” including loading dose by weight and condition.

What is ravulizumab J Code?

Ravulizumab J code is J1303 (10 mg, injection)

What happens if I miss a dose?

If you miss a Ravulizumab IV or SC dose or administer a partial SC dose, call your healthcare provider right away.

Ravulizumab Package Insert 

Review the Ravulizumab Package Insert (Ultomiris) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. 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.

The Package Insert is sometimes called Ultomiris Prescribing Information (PI) or Ultomiris FDA label.

What other drugs will affect ravulizumab?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ultomiris and other medicines can affect each other causing side effects.

• A supplemental dose of Ultomiris is required for patients administered intravenous immunoglobulins or undergoing plasma exchange, plasmapheresis
• Monitor patients taking neonatal Fc Receptor Blockers (FcRn), such as efgartigimod or rozanolixizumab, closely for reduced effectiveness of Ultomiris.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Proper Storage Instructions:

• Temperature: Keep refrigerated at 2°C – 8°C (36°F – 46°F).
• Packaging: Store in the original carton to protect from light.
• Do Not: Freeze or Shake the vial.

Storage After Dilution:

• If not used immediately, store the prepared infusion in the refrigerator at 2°C – 8°C (36°F – 46°F).
• Do not exceed 24 hours in storage, including the expected infusion time.

Always follow the product guidelines for proper handling and administration.

Ingredients

Active ingredient: ravulizumab-cwvz. 

Inactive ingredients: 

Ultomiris 100 mg/mL: L-arginine, polysorbate 80 (vegetable origin), sodium phosphate dibasic, sodium phosphate monobasic, sucrose, and Water for Injection. 

Ultomiris 10 mg/mL: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, and Water for Injection. 

Manufacturer

Manufactured by Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boulevard Boston, MA 02210 USA.

Ravulizumab 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 ravulizumab.Ultomiris (ravulizumab-cwvz) – Alexion Pharmaceuticals, Inc.

What is Rebif?

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

• The generic name for Rebif is interferon beta-1a.
• Rebif is injected under the skin (subcutaneously), usually 3 times a week, such as on a Monday, Wednesday, and Friday.

Rebif’s mechanism of action resembles that of interferons which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections. Rebif is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS.

Rebif belongs to the drug class called interferons. It may also be called an immunomodulator. Rebif will not cure MS, it will only decrease the frequency of relapse symptoms.

Rebif gained FDA approval on March 7, 2002. Another brand of interferon beta-1a given intramuscularly (into a muscle) called Avonex, was the first interferon beta-1a to be approved (May 17, 1996). There is no Rebif generic.

Rebif side effects

The most common side effects of Rebif are:

• flu-like symptoms such as:
  • muscle aches
  • fever
  • tiredness
  • chills.
• stomach pain
• changes in your liver tests.

Serious side effects and warnings

Rebif can cause the following serious side effects.

Behavioral health problems including depression and suicidal thoughts. You may have mood problems while taking Rebif, for example, depression (feeling hopeless or feeling bad about yourself), or thoughts of hurting yourself or suicide. Contact your healthcare provider immediately.

Liver problems or liver failure has been reported in people taking Rebif. Contact your healthcare provider immediately if you develop any of the following symptoms:

• nausea
• loss of appetite
• tiredness
• dark-colored urine and pale stools
• yellowing of your skin or the white part of your eye
• bleeding more easily than normal
• confusion
• sleepiness.

Rebif may cause serious allergic and skin reactions. Contact your healthcare provider or seek emergency medical attention if you develop any of the following symptoms:

• itching
• swelling of your face, eyes, lips, tongue or throat
• trouble breathing
• anxiousness
• feeling faint
• skin rash, hives, sores in your mouth, or skin blisters and peels.

Injection site problems. Rebif may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider immediately if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.

Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems.

Pulmonary arterial hypertension. Pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) can occur with interferon beta products, including Rebif. Symptoms may include new fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.

Thrombotic microangiopathy (TMA). TMA is a condition that involves injury to the smallest blood vessels in your body and this has been reported with Rebif. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking Rebif if you develop TMA.

Seizures. Some people have had seizures while taking Rebif.

Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use Rebif.

Eye Disorders: Retinal disorders (such as retinopathy, cotton wool spots, or obstruction of
the retinal artery or vein) have been reported with Rebif. See your healthcare provider immediately if you have any changes in your vision or eye pain.

During your treatment with Rebif see your healthcare provider regularly and have regular blood tests to check for side effects.

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

Before taking

Do not take Rebif if you are allergic to interferon beta-1a, human albumin, Rebif, Avonex, or any inactive ingredients in the injection (see below for a list of inactive ingredients).

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

• mental illness, including depression and suicidal behavior
• liver problems
• bleeding problems or blood clots
• low blood cell counts
• seizures (epilepsy)
• thyroid problems
• drink alcohol
• you are pregnant or plan to become pregnant
• you are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Rebif can harm your unborn baby.

Breastfeeding

Rebif may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while taking this medicine.

How should I use Rebif?

See the Instructions for Use that come with the Rebif Package Insert.

• Your healthcare provider should show you how to prepare, measure, and inject your dose of Rebif before you use it for the first time.

How to inject Rebif for subcutaneous use

Rebif is given by injection under the skin (subcutaneous injection) on the same 3 days a week, for example, Monday, Wednesday, and Friday.

• Your injections should be at least 48 hours apart.
• Try to inject Rebif at the same time the three days that you have chosen to inject it (for example, always around 10am on Monday, Wednesday, and Friday).
• The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, your stomach or buttocks.
  • Do not use the area near your waistline or within 2 inches of your navel. If you are very thin, use only the thigh or outer surface of the arm for the injection.
• Inject Rebif exactly as your healthcare provider tells you.

Your healthcare provider will tell you how much Rebif to inject and may change the dose based on how your body responds. 

• Do not change your dose unless your healthcare provider tells you to.
• Change (rotate) the injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.
• Do not inject Rebif into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way.

Rebif comes as a:

• prefilled syringe
• single-use prefilled autoinjector (Rebif Rebidose).

Your healthcare provider will decide which is best for you. Always use a new, unopened, prefilled syringe or autoinjector for each injection. Do not reuse prefilled syringes or autoinjectors.

Rebif dosing information

The recommended dose of Rebif for MS is either 22 micrograms or 44 micrograms injected subcutaneously, 3 times a week.

Titration: Generally, the starting dose should be 20% of the prescribed dose three times per week, and increased over 4 weeks to the targeted recommended dose of either 22 micrograms or 44 micrograms injected subcutaneously three times per week. Your healthcare provider will calculate this dose for you.

Pain and/or fever-relieving medicines on treatment days may help reduce side effects such as flu-like symptoms.

What other drugs will affect Rebif?

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Rebif and other medicines may affect each other causing side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

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

Storage

Store Rebif in the refrigerator between 36°F to 46°F (2°C to 8°C).

Do not freeze Rebif.

If you cannot refrigerate your Rebif pen or autoinjector, you can store it at temperatures above 36°F and below 77°F (2°C to 25°C) for up to 30 days.

Keep Rebif away from heat and light.

Rebif ingredients

Active ingredient: Rebif

Inactive ingredients: albumin (human), mannitol, sodium acetate, water for injection

Single-dose Rebif prefilled syringe is available as 8.8 mcg in 0.2 mL, and 22 mcg or 44 mcg in 0.5 mL.

Single-dose Rebif autoinjector is available as 8.8 mcg in 0.2 mL, and 22 mcg or 44 mcg in 0.5 mL.

Who makes Rebif?

EMD Serono Inc. makes Rebif.

Rebif 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 2 for Rebif.Avonex (interferon beta-1a) – Biogen Inc.

What is Reclast?

Reclast (sometimes called zoledronate) is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Reclast is used to treat or prevent osteoporosis caused by menopause, or steroid use. This medicine also increases bone mass in men with osteoporosis. Reclast is for use when you have a high risk of bone fracture.

Reclast is also used to treat Paget’s disease of bone.

Zometa is another brand of zoledronic acid used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy). This medicine also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body. You should not use Reclast and Zometa at the same time.

Warnings

Zoledronic acid may harm an unborn baby. Do not use Reclast if you are pregnant. Use effective birth control, and ask your doctor how long to prevent pregnancy after you stop this medicine.

Reclast can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Reclast have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Before taking this medicine

You should not be treated with Reclast if you are allergic to zoledronic acid.

You also should not receive Reclast if you have:

• low levels of calcium in your blood (hypocalcemia); or
• severe kidney disease.

You should not be treated with Reclast if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).

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

• kidney disease;
• hypocalcemia;
• thyroid or parathyroid surgery;
• surgery to remove part of your intestine;
• asthma caused by taking aspirin;
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption);
• a dental problem (you may need a dental exam before you receive Reclast);
• if you are dehydrated; or
• if you take a diuretic or “water pill”.

Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

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

Do not use Reclast if you are pregnant. Zoledronic acid may harm an unborn baby or cause birth defects. Zoledronic acid can remain in your body for weeks or years after your last dose. Use effective birth control to prevent pregnancy while using this medicine. Talk with your doctor about the need to prevent pregnancy after you stop using Reclast.

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

You should not breastfeed while using Reclast.

How is Reclast given?

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

Reclast is sometimes given as a single dose only one time. It may also be given once every 1 or 2 years. How often you receive Reclast will depend on why you are using this medicine. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

You may need frequent medical tests to help your doctor determine how long to treat you with Reclast. Your kidney function may also need to be checked.

Pay special attention to your dental hygiene while using Reclast. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Reclast.

Reclast is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Your doctor will determine how long to treat you with this medicine. Reclast is often given for only 3 to 5 years.

Dosing information

Usual Adult Dose for Paget’s Disease:

5 mg IV infusion, at a constant infusion rate, over no less than 15 minutes

Calcium and vitamin D supplementation:
-Calcium: 750 mg elemental calcium orally twice a day, or 500 mg orally three times a day
-Vitamin D: 800 international units orally daily, especially in the 2 weeks following drug administration

Comments: Retreatment may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase or failure to achieve normalization of serum alkaline phosphatase.

Uses: Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of age- specific normal reference range

Usual Adult Dose for Osteoporosis:

5 mg IV infusion over no less than 15 minutes, once a year

Comments: An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.

Uses:
-Osteoporosis in postmenopausal women, diagnosed by bone mineral density or prevalent vertebral fracture (this drug reduces the incidence of fractures).
-To increase bone mass in men with osteoporosis.
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Usual Adult Dose for Prevention of Osteoporosis:

5 mg IV infusion over no less than 15 minutes, every 2 years

Uses:
-Prevention of osteoporosis in postmenopausal women.
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Reclast?

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Reclast side effects

Get emergency medical help if you have signs of an allergic reaction to Reclast: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or unusual pain in your thigh or hip;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• severe joint, bone, or muscle pain;
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Serious side effects on the kidneys may be more likely in older adults.

Common Reclast side effects may include:

• trouble breathing;
• nausea, vomiting, diarrhea, constipation;
• bone pain, muscle or joint pain;
• fever or other flu symptoms;
• tiredness;
• eye pain or swelling;
• pain in your arms or legs;
• headache; or
• anemia.

What is Reglan?

Reglan increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines and may help with nausea.

Reglan is used for 4 to 12 weeks to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief.

Reglan is also used to treat gastroparesis (slow stomach emptying) in people with diabetes, which can cause heartburn and stomach discomfort after meals.

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

Warnings

Do not use Reglan if you’ve ever had muscle movement problems after using metoclopramide or similar medicines, or if you’ve had a movement disorder called tardive dyskinesia. You also should not use this medicine if you’ve had stomach or intestinal problems (a blockage, bleeding, or a hole or tear), epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Before you take Reglan, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson’s disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of metoclopramide.

Stop using Reglan and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

Before taking this medicine

You should not use Reglan if you are allergic to metoclopramide, or if you have:

• tardive dyskinesia (a disorder of involuntary movements);
• stomach or intestinal problems such as a blockage, bleeding, or perforation (a hole or tear in your stomach or intestines);
• epilepsy or other seizure disorder;
• an adrenal gland tumor (pheochromocytoma); or
• if you’ve ever had muscle movement problems after using metoclopramide or similar medicines.

Tell your doctor if you have ever had:

• liver or kidney disease;
• problems with muscle movements;
• congestive heart failure or a heart rhythm disorder;
• high blood pressure;
• seizures;
• breast cancer;
• Parkinson’s disease;
• diabetes; or
• depression or mental illness.

Tell your doctor if you are pregnant before taking metoclopramide.

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

Reglan is not FDA-approved for use by anyone younger than 18 years old.

How should I use Reglan?

Take Reglan exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

Reglan should be taken for only 4 to 12 weeks.

NEVER USE REGLAN IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of metoclopramide can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Reglan is usually taken 30 minutes before meals and at bedtime, or only with meals that usually cause heartburn. Follow your doctor’s dosing instructions very carefully.

Do not use two different forms of metoclopramide (such as tablets and oral syrup) at the same time.

Store at room temperature in a tightly-closed container, away from moisture and heat. Keep the bottle tightly closed.

After you stop taking Reglan, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness.

Dosing information

Usual Adult Dose of Reglan for Gastroesophageal Reflux Disease:

Oral: 10 to 15 mg up to 4 times a day 30 minutes before meals and at bedtime, depending upon symptoms being treated and clinical response. Therapy should not exceed 12 weeks.

Usual Adult Dose of Reglan for Gastroparesis:

During the earliest manifestations of diabetic gastric stasis, oral administration may be initiated. If severe symptoms are present, therapy should begin with IM or IV administration for up to 10 days until symptoms subside at which time the patient can be switched to oral therapy. Since diabetic gastric stasis is often recurrent, therapy should be reinstituted at the earliest manifestation.

Oral: 10 mg 4 times daily, 30 minutes before meals and at bedtime, for 2 to 8 weeks depending on clinical response.

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 . Overdose symptoms may include drowsiness, confusion, or uncontrolled muscle movements.

What to avoid

Drinking alcohol with this medicine can cause side effects.

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

Do not take Reglan with other medications that increase the risk of experiencing extrapyramidal reactions (eg, spasms, muscle contractions, jerky/rigid movements).

Reglan side effects

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

Stop taking Reglan and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

• tremors or shaking in your arms or legs;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• confusion, depression, thoughts of suicide or hurting yourself;
• slow or jerky muscle movements, problems with balance or walking;
• mask-like appearance in your face;
• a seizure;
• anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping;
• swelling, feeling short of breath, rapid weight gain; or
• severe nervous system reactionvery stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Reglan side effects may include:

• feeling restless;
• feeling drowsy or tired;
• lack of energy;
• nausea, vomiting;
• headache, confusion; or
• sleep problems (insomnia).

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 Reglan?

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

Tell your doctor about all your current medicines. Many drugs can interact with metoclopramide, especially:

• cyclosporine (Gengraf, Neoral, Sandimmune);
• digoxin (digitalis, Lanoxin);
• glycopyrrolate (Robinul);
• insulin;
• levodopa (Larodopa, Atamet, Parcopa, Sinemet);
• mepenzolate (Cantil);
• tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
• blood pressure medications;
• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), or propantheline (Pro-Banthine);
• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa, Symbyax), prochlorperazine (Compazine), risperidone (Risperdal), thiothixene (Navane), and others.

What is Relafen?

Relafen is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Relafen is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

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

Warnings

Relafen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Relafen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Relafen, especially in older adults.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Relafen (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking Relafen. Alcohol can increase the risk of stomach bleeding caused by nabumetone. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Relafen can make your skin more sensitive to sunlight and sunburn may result.

Before taking this medicine

Relafen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Relafen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Relafen, especially in older adults.

You should not use Relafen if you are allergic to nabumetone, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

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

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

If you are pregnant, you should not take Relafen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Relafen is not FDA-approved for use by anyone younger than 18 years old.

How should I take Relafen?

Take Relafen exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

You may take Relafen with or without food.

If you use this medicine long-term, you may need frequent medical tests.

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dosing information

Usual Adult Dose for Osteoarthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

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 .

What to avoid

Avoid drinking alcohol and smoking. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to Relafen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or tanning beds. Relafen can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Relafen side effects

Get emergency medical help if you have signs of an allergic reaction to Relafen: (hives, sneezing, runny or stuffy nose, wheezing, 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).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Relafen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Relafen side effects may include:

• stomach pain, indigestion, nausea;
• diarrhea, constipation, gas;
• swelling in your hands and feet;
• headache, dizziness;
• itching, skin rash; or
• ringing in your ears.

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 Relafen?

Ask your doctor before using Relafen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;
• methotrexate;
• a blood thinner (examples: warfarin, Coumadin, Jantoven, apixaban, dabigatran, rivaroxaban);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).

What is relugolix?

Relugolix is a prescription medicine used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix belongs to a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists.

Relugolix tablets work by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

Warnings

Relugolix may decrease fertility in men. Talk to your doctor about the risks.

Relugolix 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 relugolix if you are allergic to it, or if you have:

• heart problems; or
• long QT syndrome (in you or a family member).

Relugolix 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 this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take relugolix?

Take relugolix tablets 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.

Relugolix is usually taken as 3 tablets the first day, followed by 1 tablet per day.

Take the medicine at the same time each day, with or without food.

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

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 relugolix. 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.

Dosing information

Usual Adult Dose for Prostate Cancer:

Loading Dose: 300 mg orally once on the first day
Maintenance Dose: 120 mg orally once a day

Comment:
-Treatment is usually continued upon 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 other drugs will affect relugolix?

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.

Relugolix 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 relugolix. 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.

Many drugs can interact with relugolix. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

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 relugolix?

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

Relugolix side effects

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

Relugolix 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.

Common relugolix side effects may include:

• flushing (sudden warmth, redness, or tingly feeling);
• feeling tired;
• high blood sugar;
• high cholesterol or triglycerides;
• (anemia) low red blood cells;
• depressed mood;
• weight gain;
• impotence, sexual problems;
• abnormal growth of breast tissue;
• diarrhea, constipation;
• muscle or joint pain; or
• abnormal lab tests (liver, blood).

What is Remeron?

Remeron is an antidepressant. The way mirtazapine works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.

Remeron is prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.

It is not known if Remeron is safe and effective for use in treating MDD in children.

Warnings

You should not take Remeron if you are also taking tryptophan (sometimes called L-tryptophan).

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

Some people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Remeron. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. Mirtazapine is not approved for use in children.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Drinking alcohol can increase certain side effects of mirtazapine.

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

Do not stop taking mirtazapine abruptly. Talk to your doctor before stopping mirtazapine.

Before taking this medicine

You should not take Remeron if you are allergic to mirtazapine or any of the ingredients in Remeron or Remeron SolTab.

Do not use Remeron if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

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

• low white blood cell counts;
• glaucoma;
• liver or kidney disease;
• low sodium levels in your blood;
• a seizure;
• depression, suicidal thoughts or actions;
• bipolar disorder (manic depression) in you or a family member;
• heart problems or stroke;
• high cholesterol or triglycerides;
• long QT syndrome (in you or a family member); or
• low blood pressure.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with mirtazapine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

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

How should I take Remeron?

Take Remeron 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.

Take the medicine at the same time each day, usually at bedtime.

Take the regular Remeron tablet with water.

You may take this medicine with or without food.

Remove a Remeron SolTab orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

It may take a few weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Do not stop using Remeron suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Depression:

Initial dose: 15 mg orally once a day at bedtime
Maintenance dose: 15 to 45 mg orally once a day
Maximum dose: 45 mg/day

Comments:
-May increase the dose every 1 to 2 weeks to a maximum 45 mg/day according to patient response.
-Patients should be periodically reassessed to determine the need for continued use of this drug.

Use: Treatment of major depressive disorder

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 .

Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.

What to avoid

Drinking alcohol with this medicine can cause side effects.

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

Remeron side effects

Get emergency medical help if you have signs of an allergic reaction to Remeron (hives, joint pain, fever, 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).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• a light-headed feeling, like you might pass out;
• severe rash, blisters, or swelling on the palms of your hands or the soles of your feet;
• a seizure;
• low white blood cell counts – fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or
• low sodium level – headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Remeron side effects include:

• drowsiness, dizziness;
• increased appetite; or
• weight gain.

What is Remicade?

Remicade reduces the effects of a substance in the body that can cause inflammation.

Remicade is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and severe or disabling plaque psoriasis in adults.

Remicade is also used to treat ulcerative colitis and Crohn’s disease in adults and children at least 6 years old.

Infliximab is often used when other medicines have not been effective.

Warnings

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia).

Using Remicade may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. Ask your doctor about your specific risk.

Remicade affects your immune system. You may get infections more easily, even serious or fatal infections. Before you start using Remicade, your doctor may perform tests to make sure you do not have certain infections. Call your doctor if you have a fever, tiredness, flu symptoms, cough, or skin pain.

Before taking this medicine

Tell your doctor if you have ever had tuberculosis (TB), or anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

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

• heart failure or other heart problems;
• an active infection (fever, cough, flu symptoms, open sores or skin wounds);
• diabetes;
• liver failure, hepatitis B, or other liver problems;
• chronic obstructive pulmonary disease (COPD);
• heart problems;
• cancer;
• a weak immune system;
• seizures;
• numbness or tingling anywhere in your body;
• a nerve-muscle disorder, such as multiple sclerosis or Guillain-Barré syndrome;
• phototherapy for psoriasis;
• vaccination with BCG (Bacille Calmette-Guérin); or
• if you are scheduled to receive any vaccines.

Make sure your child is current on all vaccines before he or she starts treatment with Remicade.

Remicade may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Remicade may cause other types of cancer, such as skin cancer or cancer of the cervix. Ask your doctor about this risk.

If you use infliximab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to infliximab in the womb could affect your baby’s vaccination schedule during the first 6 months of life.

You should not breastfeed while you are receiving infliximab.

Remicade is not for use in children younger than 6 years old.

How is Remicade given?

Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

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

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

You may be watched closely after receiving infliximab, to make sure the medicine has not caused any serious side effects.

Infliximab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis, and you may need frequent TB tests.

Serious infections may be more likely in older adults.

If you need surgery, tell the surgeon ahead of time that you are using Remicade.

If you’ve ever had hepatitis B, using infliximab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Remicade?

Avoid activities that may increase your risk of bleeding injury.

Do not receive a “live” vaccine while using infliximab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, and varicella (chickenpox).

Remicade side effects

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy or tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

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

Serious and sometimes fatal infections may occur during treatment with Remicade. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).

Also call your doctor if you have:

• skin changes, new growths on the skin;
• pale skin, easy bruising or bleeding;
• delayed allergic reaction (up to 12 days after receiving Remicade) – fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands;
• liver problems – right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes (jaundice), and not feeling well;
• lupus-like syndrome – joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
• nerve problems – numbness or tingling, problems with vision, weakness in your arms or legs, seizure;
• new or worsening psoriasis – skin redness or scaly patches, raised bumps filled with pus;
• signs of heart failure – shortness of breath with swelling of your ankles or feet, rapid weight gain;
• signs of a stroke – sudden numbness or weakness, trouble speaking or understanding what is said to you, problems with vision or balance, severe headache;
• signs of lymphoma – fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Serious infections may be more likely in adults who are 65 years or older.

Common Remicade side effects may include:

• stuffy nose, sinus pain;
• fever, chills, sore throat;
• cough, chest pain, shortness of breath;
• high or low blood pressure;
• headache, feeling light-headed;
• rash, itching; or
• stomach pain.

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 Remicade?

Tell your doctor about all your other medicines, especially:

• abatacept;
• anakinra;
• tocilizumab;
• any “biologic” medications to treat your condition – adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others; or
• any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

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

Remicade 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 2 for Remicade.Remicade (infliximab) – Janssen Biotech, Inc.

What is Renflexis?

Renflexis (infliximab-abda) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.

Renflexis is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar versions of the drug, which are designed to have the same effect, but which are not identical.

Renflexis works in the same way as the other versions of infliximab, by blocking the damage that results from too much tumor necrosis factor-alpha (TNF-alpha). Renflexis binds to TNF-alpha, which stops it from interacting with its receptors and activating certain processes.

TNF-alpha is a protein and inflammatory cytokine which plays a key role in your normal immune response. It is involved in your inflammatory response and also helps to fight off infection and cancer. Some people, however, produce too much TNF-alpha and this can cause an autoimmune disease to develop.

Renflexis was approved by the US Food and Drug Administration (FDA) in 2017, almost 20 years after the original version of infliximab started being used.

What is Renflexis used for?

Renflexis is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
• Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

Important information

Renflexis may cause serious side effects, including:

1. Risk of infection

Renflexis is a medicine that affects your immune system. Renflexis can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Renflexis. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting Renflexis.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Renflexis.

Before starting Renflexis, tell your doctor if you:

• think you have an infection. You should not start receiving Renflexis if you have any kind of infection.
• are being treated for an infection.
• have signs of an infection, such as a fever, cough, flu-like symptoms.
• have any open cuts or sores on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive Renflexis. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B.
• use the medicines Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics used to treat the same conditions as Renflexis.

After starting Renflexis, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Renflexis can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using TNF-blocker medicines, such as Renflexis.
• For children and adults receiving TNF-blocker medicines, including Renflexis, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF-blockers, including Renflexis, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products, such as Renflexis, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Renflexis, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Renflexis.
• Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Renflexis, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

See the section “What are the possible side effects of Renflexis?” below for more information.

Who should not receive Renflexis?

You should not receive Renflexis if you have:

• heart failure, unless your doctor has examined you and decided that you are able to receive Renflexis. Talk to your doctor about your heart failure.
• had an allergic reaction to infliximab products, or any of the other ingredients in Renflexis. See below for a complete list of ingredients in Renflexis.

What should I tell my doctor before receiving Renflexis?

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you:

• have an infection (see “Important information” above).
• have other liver problems including liver failure.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you take Renflexis.
• have or have had any type of cancer.
• have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Renflexis.
• have COPD. Patients with COPD may have an increased risk of getting cancer while receiving Renflexis.
• have or have had a condition that affects your nervous system such as:
  • multiple sclerosis, or Guillain-Barré syndrome, or
  • if you experience any numbness or tingling, or
  • if you have had a seizure.
• have recently received or are scheduled to receive a vaccine. Adults and children receiving Renflexis should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Children should have all of their vaccines brought up to date before starting treatment with Renflexis.

How should I receive Renflexis?

• You will be given Renflexis through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Your doctor may decide to give you medicine before starting the Renflexis infusion to prevent or lessen side effects.
• Only a healthcare professional should prepare the medicine and administer it to you.
• Renflexis will be given to you over a period of about 2 hours.
• If you have side effects, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
• A healthcare professional will monitor you during the infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Renflexis to monitor you for side effects and to see how well you respond to the treatment.
• Your doctor will determine the right dose for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.

What should I avoid while receiving Renflexis?

Do not take Renflexis together with medicines such as Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics that are used to treat the same conditions as this medication.

Dosing information

Renflexis is administered by intravenous infusion over a period of not less than 2 hours.

• Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
• Pediatric Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Pediatric Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Rheumatoid Arthritis
  • In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
• Ankylosing Spondylitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
• Psoriatic Arthritis and Plaque Psoriasis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

What are the side effects of Renflexis?

Serious side effects of Renflexis include:

• See “Important information” above.
• Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Renflexis. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Renflexis your doctor will treat your infection and may need to stop your Renflexis treatment.
  • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Renflexis:
    • a fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Renflexis and during treatment with Renflexis.
  • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Renflexis. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
  • If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Renflexis. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Renflexis and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
    • feel unwell
    • tiredness (fatigue)
    • poor appetite
    • fever, skin rash, or joint pain
• Heart Failure
  If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Renflexis. Your congestive heart failure may get worse while you are receiving Renflexis. Be sure to tell your doctor of any new or worse symptoms including:
  • shortness of breath
  • swelling of ankles or feet
  • sudden weight gain
    Treatment with Renflexis may need to be stopped if you get new or worse congestive heart failure.
• Other Heart Problems
  Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of an infliximab product. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
• Liver Injury
  Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
  • jaundice (skin and eyes turning yellow)
  • dark brown-colored urine
  • pain on the right side of your stomach area (right-sided abdominal pain)
  • fever
  • extreme tiredness (severe fatigue)
• Blood Problems
  In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
  • have a fever that does not go away
  • bruise or bleed very easily
  • look very pale
• Nervous System Disorders
  Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
  • changes in your vision
  • numbness or tingling in any part of your body
  • weakness in your arms or legs
  • seizures
    Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
• Allergic Reactions
  Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Renflexis treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Renflexis and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
  • hives (red, raised, itchy patches of skin)
  • difficulty breathing
  • chest pain
  • high or low blood pressure
  • fever
  • chills
    Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Renflexis:
    • fever
    • rash
    • headache
    • sore throat
    • muscle or joint pain
    • swelling of the face and hands
    • difficulty swallowing
• Lupus-like Syndrome
  Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Renflexis.
  • chest discomfort or pain that does not go away
  • shortness of breath
  • joint pain
  • rash on the cheeks or arms that gets worse in the sun
• Psoriasis
  Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Renflexis.

The most common side effects of infliximab products include:

• respiratory infections, such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Renflexis. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

Children with Crohn’s disease showed some differences in side effects of treatment compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Renflexis. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Renflexis harms your unborn baby. Renflexis should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Renflexis if you are pregnant or plan to become pregnant.

If you have a baby and you were receiving Renflexis during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Renflexis use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Renflexis while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Renflexis passes into your breast milk. Talk to your doctor about the best way to feed your baby while receiving Renflexis. You should not breast-feed while receiving Renflexis.

Storage

Store unopened Renflexis vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

If needed, unopened Renflexis vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, Renflexis cannot be returned to the refrigerator.

What are the ingredients in Renflexis?

Active ingredient: infliximab-abda.

Inactive ingredients: dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Renflexis is manufactured by Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea.

Renflexis 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 2 for Renflexis.Remicade (infliximab) – Janssen Biotech, Inc.

What is repaglinide?

Repaglinide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. repaglinide is not for treating type 1 diabetes.

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

Repaglinide 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 eyes, skin pain, red or purple skin rash with blistering and peeling).

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

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
• pancreatitis–severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common side effects of repaglinide may include:

• low blood sugar;
• nausea, diarrhea;
• headache, back pain;
• joint pain; 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.

Warnings

You should not use repaglinide if you have type 1 diabetes, severe liver disease, or diabetic ketoacidosis.

You should not use repaglinide together with gemfibrozil or NPH insulin (such as isophane insulin).

Before taking this medicine

You should not use repaglinide if you are allergic to it, or if you have:

• severe liver disease; or
• diabetic ketoacidosis (call your doctor for treatment).

Many drugs can interact with repaglinide and some drugs should not be used at the same time. Your doctor may change your treatment plan if you also use:

• clopidogrel;
• cyclosporine;
• gemfibrozil; or
• NPH insulin (such as isophane insulin).

Tell your doctor if you have ever had:

• liver disease; or
• if you also take metformin or other diabetes medicines.

Follow your doctor’s instructions about using repaglinide if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

You should not breastfeed while using repaglinide.

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

How should I take repaglinide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Repaglinide is usually taken 2 to 4 times daily, within 30 minutes before eating a meal. Follow your doctor’s instructions. If you skip a meal, do not take your dose of repaglinide. Wait until your next meal.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor’s office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Repaglinide is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store repaglinide at room temperature away from moisture and heat.

Repaglinide dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize therapy:
Dose preprandially 2, 3, or 4 times a day
-For patients not previously treated with antidiabetic agents or whose glycosylated hemoglobin (HbA1c) is less than 8%:
Initial dose: 0.5 mg orally with each meal
-For patients previously treated with antidiabetic agents or whose HbA1c is 8% or higher:
Initial dose: 1 or 2 mg orally with each meal

Dose Adjustments: Based upon blood glucose response, double the preprandial dose up to a maximum meal time dose of 4 mg until satisfactory glycemic response is achieved; allow at least 1 week to assess response after each dose adjustment.
Recommended Dose Range: 0.5 to 4 mg orally with each meal
Maximum Daily Dose: 16 mg per day

Comments:
-Fasting blood glucose concentrations are generally used to adjust doses, however, postprandial glucose levels may be used in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate.
-When hypoglycemia occurs in patients taking this drug in combination with a thiazolidinedione or metformin, the dose of this drug should be reduced.

What happens if I miss a dose?

Take your dose as soon as you can, but only if you are getting ready to eat a meal. If you skip a meal, skip the missed dose and wait until your next meal.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . A repaglinide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking repaglinide?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What other drugs will affect repaglinide?

Many other medicines that can increase or decrease the effects of repaglinide on lowering your blood sugar. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is Repatha?

Repatha is used to lower high cholesterol alongside dietary changes and to reduce the risk of major cardiovascular events in those with cardiovascular disease, such as death from cardiovascular disease, heart attack, stroke, angina requiring hospitalization, or certain types of heart surgery.

It is given as an injection under the skin (subcutaneously), every 2 weeks or 1 time each month.

FDA-approved uses and indications

Repatha (evolocumab) is an injectable prescription medicine approved:

• to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, certain types of chest pain conditions (unstable angina) requiring hospitalization, or certain types of heart surgery, in adults with established cardiovascular disease
• to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone, or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies 
• to reduce LDL-C in children aged 10 years and older with HeFH as an adjunct to diet and other LDL-C-lowering therapies 
• to reduce LDL-C in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other LDL-C-lowering therapies.

It is not known if Repatha is safe and effective in children with HeFH or HoFH who are younger than 10 years of age or in children with other types of hyperlipidemia.

Repatha received FDA approval on August 27, 2015. There is no Repatha generic or biosimilar.

Mechanism of action

Repatha works by helping the liver reduce levels of “bad” cholesterol (low-density lipoprotein, or LDL) circulating in your blood.

Its mechanism involves binding to and blocking a protein called PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in the liver.

• Normally, PCSK9 attaches to LDL receptors on liver cells and triggers their degradation.
• These receptors are responsible for removing LDL (“bad”) cholesterol from the blood.
• By inhibiting PCSK9, Repatha prevents the degradation of LDL receptors, allowing more of them to remain on liver cell surfaces and remove more LDL cholesterol from the blood.

Clinical trials report significant reductions in blood LDL cholesterol levels (often 50-60% or more).

How much does Repatha cost?

Repatha has broad coverage over most insurance types, so the cost of Repatha depends on the type of insurance you have. For example, with the Repatha Co-Pay card, those with commercial insurance pay as little as $15 a month. For those with Medicaid, 99% of Repatha prescriptions cost people $10 or less.

Side effects

The most common side effects of Repatha are:

• Cold symptoms like a runny nose and sore throat
• Flu or flu-like symptoms
• Back pain
• High blood sugar/diabetes
• Injection site reactions such as redness, pain, or bruising.

Serious side effects and warnings

Repatha can cause the following serious side effects:

• Serious allergic reactions. Some people taking Repatha have had serious allergic reactions. Stop taking Repatha and call your healthcare provider or seek emergency medical help right away if you or your child has any of these symptoms:
  • trouble breathing or swallowing
  • raised bumps (hives)
  • rash, or itching
  • swelling of the face, lips, tongue, throat, or arms.

Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. Ask your healthcare provider for the Repatha SureClick autoinjector or injection that does not contain dry natural rubber if you are sensitive to latex. 

Tell your healthcare provider if you or your child has any side effect that bothers you or does not go away. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects or see the Repatha Package Insert.

Before taking this medicine

You should not use Repatha if you are allergic to evolocumab, Repatha, or any ingredients in the Repatha injection (see below for a list of ingredients).

Before you or your child start using Repatha, tell your healthcare provider about all your medical conditions, including if you or your child:

• are allergic to rubber or latex. Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. The carton and “Repatha Instructions for Use” will state if your prefilled single-dose SureClick autoinjector or prefilled single-dose syringe contains dry natural rubber.
  • The single-dose Pushtronex® system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.
• have liver or kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Do not give Repatha to a child without medical advice and is not approved for use by anyone younger than 10 years old. For certain conditions, Repatha should not be given to a child of any age.

Pregnancy

It is not known if Repatha will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Repatha. If you or your child are pregnant during Repatha treatment .

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks. If you or your child breastfeeds during Repatha treatment, you are encouraged to call Amgen at 1-800-772-6436 (1-800-77-AMGEN) or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting to share information about the health of you and your baby or your child and your child’s baby.

How is Repatha given?

See the detailed Instructions for Use that come with the Repatha Package Insert about the right way to prepare and give Repatha.

• Use Repatha exactly as your healthcare provider tells you or your child to use it.
• Repatha is given under the skin (subcutaneously), every 2 weeks or 1 time each month.
• If your healthcare provider decides that you or your child, or a caregiver, can give Repatha, you or your child or your caregiver should receive training on the right way to prepare and inject Repatha.
  • Do not try to inject Repatha until you or your child has been shown the right way by your healthcare provider or nurse.
• You or your child can inject Repatha into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around the belly button.
  • Your healthcare provider will show you the best places on your body to inject Repatha or place the on-body infusor. Use a different place each time you give an injection. Do not inject into the same place twice in a row.
  • Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch.

If you or your child has HoFH, the recommended starting dose is 420 mg once a month. After 12 weeks, your healthcare provider may increase the dose to 420 mg every two weeks.

• If you or your child receives lipid apheresis, your healthcare provider may decide to start you or your child on a dose of 420 mg every two weeks to match the apheresis treatment, and you or your child should take the dose after the apheresis treatment.

Repatha comes as a prefilled single-dose (1 time) autoinjector (SureClick autoinjector), as a prefilled single-dose syringe, or as a single-dose Pushtronex system (on-body infusor with prefilled cartridge). Your healthcare provider will prescribe the type and dose that is best for you or your child.

• It may take up to 15 seconds to inject Repatha using a prefilled syringe or a SureClick autoinjector. If you use more than one injection at a time, be sure to finish all injections within 30 minutes.
• Each single-use prefilled syringe, cartridge, or injection device is for one use only. Throw away after one use, even if there is still some medicine left inside. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” 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.
• Full patient instructions with diagrams are available on the Repatha Package Insert.
• Ask your doctor or pharmacist if you have any questions about your injection device, or call the manufacturer at 1-844-737-2842.

If your healthcare provider prescribes you or your child the 420 mg dose, you or your child may use:

• a single-dose on-body infusor with the prefilled cartridge to give the injection over 5 minutes, or
• 3 separate injections in a row, using a different prefilled single-dose SureClick autoinjector or prefilled single-dose syringe for each injection. Give all of these injections within 30 minutes.

If you or your child is using the prefilled single-dose SureClick autoinjector, put the yellow safety guard
(needle inside) of the prefilled single-dose SureClick autoinjector on the skin before injecting.

You should not stop using Repatha without your doctor’s advice, or your LDL cholesterol levels may increase.

Repatha is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor’s instructions very closely.

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

Repatha Pushtonex system

The Pushtronex on-body infusor is a special hands-free device placed on the skin that delivers Repatha slowly. Read and carefully follow all instructions for using this product. You need to wear the device for about 9 minutes to get the full dose. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching.

Repatha dosing instructions

Repatha is usually given 1 time a month or once every 2 weeks.

• Depending on your dose amount, you may need to use up to 3 separate injections at one time.
• Follow your doctor’s dosing instructions very carefully.

Usual Adult Dose for Hyperlipidemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia: Repatha 420 mg subcutaneously 1 time a month.

• May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
• Adults on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.

Usual Adult Dose for Cardiovascular Risk Reduction: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Child Dose (10 and older) for Homozygous Familial Hypercholesterolemia: Repatha 420 mg subcutaneously 1 time a month.

• May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
• Children on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.

Usual Child Dose (10 and older) for Heterozygous Familial Hypercholesterolemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

What happens if I miss a dose of Repatha?

If you or your child forgets to use Repatha or cannot administer the dose at the regular time, inject your or your child’s missed dose as soon as you remember, as long as it is within 7 days of the missed dose.

More than 7 days from the missed dose

If it is more than 7 days from the missed dose and you or your child are using the every-2-week dose, inject the next dose based on the original schedule. This will put you or your child back on the original schedule.

If it is more than 7 days from the missed dose and you or your child are using the 1-time each-month dose, inject the dose and start a new schedule using this date.

If you or your child are not sure when to take Repatha after a missed dose, ask your healthcare provider or pharmacist. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Repatha?

Do not inject Repatha into skin that is bruised, sore, scarred, or hardened.

Do not shake Repatha. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for more medicine.

What other drugs will affect Repatha?

Other drugs may interact with evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

How do I store Repatha?

Store Repatha in the refrigerator in its original carton and protect from light and heat. Do not freeze. Throw away any medicine that has been frozen.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or injection device.

You may also store Repatha in the original carton at cool room temperature, away from light and heat. Use the medicine within 30 days if it is kept at room temperature.

Handle this medicine carefully. Dropping an injection device can cause it to break. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. Call your pharmacist for new medicine.

What are the ingredients in Repatha?

Active ingredient: evolocumab

Inactive ingredients: proline; acetate; polysorbate 80; water for injection, USP; and sodium hydroxide.

Available as:

• Injection: 140 mg/mL solution prefilled single-dose SureClick autoinjector (with or without latex)
• Injection: 140 mg/mL solution prefilled single-dose syringe (with or without latex)
• Injection: 420 mg/3.5 mL solution single-dose Pushtronex system (on-body infusor with prefilled cartridge) (with or without latex)

Who makes Repatha?

Repatha (evolocumab) is made by Amgen, a biotechnology company headquartered in California. Notable drugs from Amgen include:

• Enbrel (rheumatoid arthritis, psoriasis)
• Prolia/Xgeva (osteoporosis/bone disorders)
• Neulasta/Neupogen (boost white blood cells during chemotherapy)
• Otezla (psoriasis, psoriatic arthritis)
• Lumakras (lung cancer)
• Amjevita (biosimilar to Humira)
• Epogen/Aranesp (anemia)
• Tezspire (severe asthma – partnered with AstraZeneca)

Amgen has been particularly significant in developing biologics (protein-based drugs) and biosimilars. They were one of the first biotech companies to successfully develop and commercialize recombinant DNA technology for medical treatments.

Repatha 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 Repatha.Repatha (evolocumab) – Amgen Inc.

What is Requip?

Requip is a dopaminergic agent and it has some of the same effects as dopamine, a naturally occuring chemical found in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Requip is used to treat symptoms of Parkinson’s disease (stiffness, tremors, muscle spasms, and poor muscle control). Ropinirole is also used to treat restless legs syndrome (RLS).

Only immediate-release Requip is approved to treat either Parkinson symptoms or RLS. Extended-release Requip XL is approved only to treat Parkinson symptoms.

Parkinson’s and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Warnings

Requip 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. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking Requip.

Do not share this medication with another person, even if they have the same symptoms you do. Avoid drinking alcohol, which can increase some of the side effects of Requip. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by ropinirole. Tell your doctor if you regularly use any of these other medicines.

Requip may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you experience hallucinations.

Do not stop using Requip or change your dose without first talking to your doctor. You may have side effects such as fever, muscle stiffness, and confusion if you stop the medication suddenly or if you change doses.

Some people taking medicines for Parkinson’s disease have developed skin cancer (melanoma). However, people with Parkinson’s disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin examinations.

Before taking this medicine

You should not use Requip if you are allergic to ropinirole.

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

• high or low blood pressure;
• kidney disease (or if you are on dialysis);
• heart disease, heart rhythm problems;
• a sleep disorder such as narcolepsy, or other conditions that may cause daytime sleepiness; or
• if you smoke.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

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

It is not known whether ropinirole passes into breast milk or if it could affect the nursing baby. Ropinirole may slow breast milk production. Tell your doctor if you are breast-feeding.

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

How should I take Requip?

Take Requip exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you are taking immediate-release Requip tablets you should not take the extended-release tablets at the same time.

The dose and timing of Requip in treating Parkinson’s disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of ropinirole you receive at the pharmacy.

Requip can be taken with or without food. Take the medicine at the same time each day.

Do not crush, chew, or break an extended-release Requip XL tablet. Swallow the tablet whole.

Call your doctor if you see part of the tablet in your stool. This is a sign that your body may not have absorbed all of the medicine.

If you are taking this medicine for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Requip suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

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

Dosing information

Usual Adult Dose of Requip for Parkinson’s Disease:

Immediate-release tablets:
Initial: 0.25 mg orally three times daily

After 1 week, the dose may be titrated up in weekly increments based on individual efficacy and tolerability:
Week 2: give 0.5 mg orally 3 times daily
Week 3: give 0.75 mg orally 3 times daily
Week 4: give 1 mg orally 3 times daily
After week 4, increase by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, then increase by 3 mg/day on a weekly basis up to a maximum daily dose of 24 mg
Maximum Dose: 8 mg orally three times a day

Extended-release tablets:
Initial: 2 mg orally once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals, depending on therapeutic response and tolerability
Maximum dose: 24 mg orally once a day

Patients may switch from immediate-release to extended-release: The initial dose of extended-release tablet should most closely match the total daily dose of immediate-release formulation. Following conversion, adjust dose depending on response and tolerability.

Comments:
-If significant interruption in therapy occurs, retitration may be necessary; upon discontinuation, this drug should be gradually tapered over a 7-day period.
-The extended-release tablet is designed to release medication over a 24-hour period, if rapid gastrointestinal transit occurs, and tablet residue is observed in the stool, there is a risk of incomplete release of medication,

Use: For the treatment of Parkinson’s disease.

Usual Adult Dose for Restless Legs Syndrome:

Immediate-release tablets:
Initial: 0.25 mg orally once a day on Day 1 and Day 2
Dose titration: May titrate as follows based on individual efficacy and tolerability:
Days 3 to 7: give 0.5 mg orally once a day
-Week 2: give 1 mg orally once a day
-Week 3: give 1.5 mg orally once a day
-Week 4: give 2 mg orally once a day
-Week 5: give 2.5 mg orally once a day
-Week 6: give 3 mg orally once a day
-Week 7: give 4 mg orally once a day
Maximum Dose: 4 mg orally once a day

Comments:
-Take 1 to 3 hours before bedtime.
-In clinical trials, this drug was not tapered prior to discontinuation.

Use: For the treatment of moderate to severe Restless Legs Syndrome.

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 .

What to avoid

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Dizziness may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Drinking alcohol can increase certain side effects of Requip.

Requip side effects

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

Some people taking Requip have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

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.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• worsening or no improvement in your symptoms;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior;
• tremors, twitching uncontrollable muscle movements; or
• hallucinations (seeing or hearing things that are not real).

Side effects such as confusion or hallucinations may be more likely in older adults.

Common Requip side effects may include:

• drowsiness, dizziness, weakness;
• headache, confusion, hallucinations;
• increased blood pressure (severe headache, pounding in your neck or ears, nosebleed, irregular heartbeats);
• nausea, vomiting, upset stomach, constipation;
• flu symptoms (fever, chills, body aches);
• sudden muscle movements;
• increased sweating; or
• swelling in your legs or feet.

What is Restoril?

Restoril is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Temazepam affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Restoril is used to treat insomnia (trouble falling or staying asleep).

Restoril works by slowing down the central nervous system (brain), causing drowsiness which helps patients fall asleep.

Warnings

Restoril can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

Never take Restoril if you do not have at least 7 to 8 hours to sleep before being active again.

Do not use Restoril if you are pregnant. Temazepam can cause birth defects or life-threatening withdrawal symptoms in a newborn. Use effective birth control to prevent pregnancy while taking this medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Restoril and talk with your doctor about another treatment for your sleep disorder.

Temazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be shared with another person, especially someone who has a history of drug abuse or addiction. MISUSE OF TEMAZEPAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Temazepam may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take this medication only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Before taking this medicine

You should not use Restoril if you are allergic to temazepam.

Do not use Restoril if you are pregnant or may become pregnant. This medicine could harm the unborn baby.

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

• lung disease or breathing problems;
• depression, mental illness, suicidal thoughts;
• alcoholism or drug addiction; or
• liver or kidney disease.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

How should I take Restoril?

Take Restoril exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Restoril in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking Restoril for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Restoril should be used for only a short time. Do not take this medicine for longer than 2 weeks without your doctor’s advice.

Do not stop using this medicine without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Dosing information

Usual Adult Dose for Insomnia:

7.5 to 30 mg orally once a day at bedtime

Comments:
-In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency.
-In elderly or debilitated patients, therapy should be initiated at 7.5 mg until individual responses are determined.

Use: Short-term treatment of insomnia (generally 7 to 10 days)

What happens if I miss a dose?

Restoril is used when needed. If you are on a dosing schedule, skip any missed dose. Take this medicine only when you have time for several hours of sleep. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of temazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness, confusion, or coma.

What should I avoid while taking Restoril?

Do not drink alcohol. Dangerous side effects or death could occur.

You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

Restoril side effects

Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Restoril: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Restoril can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• confusion, agitation, hallucinations;
• depressed mood; or
• thoughts of suicide or hurting yourself.

Some people using Restoril have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Restoril side effects may include:

• drowsiness, tiredness;
• dizziness;
• headache;
• nausea; or
• feeling nervous.

After you stop using Restoril, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

What is Retevmo?

Retevmo (selpercatinib) is an oral kinase inhibitor that may be used to treat the following cancers caused by abnormal RET (rearranged during transfection) genes:

• locally advanced non-small cell lung cancer (NSCLC) or NSCLC that has spread in adults
• advanced or metastatic thyroid cancer in adults and children aged 2 years of age and older who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
• advanced medullary thyroid cancer (MTC) or MTC that has spread and requires a medicine that treats the whole body (systemic therapy) in adults and children aged 2 years and older.

Retevmo is also approved under the accelerated approval designation for adults and children aged 2 years and older with locally advanced solid tumors (cancers) or solid tumors associated with abnormal RET genes that have spread or gotten worse (progressed) after other treatments, or who have no satisfactory alternative treatment options.

Note: Continued approval under the accelerated approval designation is contingent upon a continued benefit in clinical trials.

Your healthcare provider will perform a test for abnormal RET genes to make sure that Retevmo is right for you.

It is not known if Retevmo is safe and effective when used in children younger than 2 years of age for the treatment of MTC, thyroid cancer, solid tumors, or other cancers.

Retevmo first gained FDA-approval on May 8, 2020.

Retevmo side effects

The most common side effects of Retevmo include:

• swelling of your arms, legs, hands, and feet (edema)
• diarrhea
• tiredness
• dry mouth
• high blood pressure
• stomach-area (abdominal) pain
• constipation
• rash
• nausea
• headache.

The most common severe abnormal laboratory test results with Retevmo include decreased white blood cell count, decreased levels of sodium in the blood, and decreased levels of calcium in the blood.

Retevmo may affect fertility in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Serious side effects

Retevmo may cause serious side effects, including:

• Liver problems. Liver problems (increased liver enzymes) are common with Retevmo and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment to check for liver problems. Tell your healthcare provider right away if you get any of the following symptoms of liver problems during treatment:
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark “tea-colored” urine
  • sleepiness
  • bleeding or bruising
  • loss of appetite
  • nausea or vomiting
  • pain on the upper right side of your stomach area
• Lung problems. Retevmo may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including:
  • shortness of breath
  • cough
  • fever
• High blood pressure (hypertension). High blood pressure is common with Retevmo and may sometimes be serious. You should check your blood pressure regularly during treatment. Tell your healthcare provider if you get any of the following symptoms:
  • confusion
  • headaches
  • shortness of breath
  • dizziness
  • chest pain
• Heart rhythm changes (QT prolongation) can occur and may be serious. Retevmo may cause very slow, very fast or irregular heartbeats. Tell your healthcare provider right away if you get any of the following symptoms:
  • loss of consciousness
  • fainting
  • dizziness
  • a change in the way your heart beats (heart palpitations)
• Bleeding problems. Retevmo can cause bleeding which can be serious and may lead to death. Tell your healthcare provider if you have any signs of bleeding during treatment, including:
  • vomiting blood or if your vomit looks like coffee-grounds
  • pink or brown urine
  • red or black (looks like tar) stools
  • coughing up blood or blood clots
  • unusual bleeding or bruising of your skin
  • menstrual bleeding that is heavier than normal
  • unusual vaginal bleeding
  • nose bleeds that happen often
  • drowsiness or difficulty being awakened
  • confusion
  • headache
  • change in speech
• Allergic reactions. Retevmo can cause a fever, rash, muscle or joint pain, especially in the first month of treatment. Tell your healthcare provider if you get any of these symptoms.
• Tumor lysis syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and an abnormal heartbeat. TLS can lead to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well hydrated during treatment with Retevmo. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with Retevmo:
  • nausea
  • shortness of breath
  • vomiting
  • muscle cramps
  • weakness
  • seizures
  • swelling
• Risk of wound healing problems. Wounds may not heal properly during treatment with Retevmo. Tell your healthcare provider if you plan to have any surgery before or during treatment with Retevmo.
  • Stop taking Retevmo at least 7 days before planned surgery.
  • Your healthcare provider should tell you when you may start taking Retevmo again after surgery.

A hip condition called a slipped capital femoral epiphysis/slipped upper femoral epiphysis (SCFE/SUFE) that can occur in teens who are still growing was reported in one adolescent in clinical trials. Report any pain in the groin, hip, knee, or thigh to your healthcare provider especially if it is intermittent or worsens with activity.

Before taking Retevmo

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

• have liver problems
• have high blood pressure
• have heart problems including a condition called QT prolongation
• have bleeding problems
• plan to have surgery. Stop taking Retevmo at least 7 days before your planned surgery. See Retevmo side effects.
• are pregnant or plan to become pregnant. Retevmo can harm your unborn baby. You should not become pregnant during treatment.
  • If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final dose. Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.
  • Males with female partners who are able to become pregnant should use effective birth control during treatment, and for at least 1 week after the final dose.
• are breastfeeding or plan to breastfeed. It is not known if Retevmo passes into your breast milk. Do not breastfeed during treatment, and for 1 week after the last dose.

How should I take Retevmo?

Take Retevmo exactly as your healthcare provider tells you. Your healthcare provider may stop treatment or change your dose if you have side effects. Do not change your dose or stop treatment unless your healthcare provider tells you.

• Retevmo is taken by mouth, usually 2 times a day (about 12 hours apart) with or without food.
• If you take a proton-pump inhibitor (PPIs such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, and rabeprazole), take Retevmo with food.
• If you take an antacid that contains aluminum, magnesium, calcium, simethicone, or buffered medicines, take Retevmo 2 hours before or 2 hours after taking the antacid.
• If you take an H2 blocker (such as famotidine, nizatidine, and cimetidine), take Retevmo 2 hours before or 10 hours after taking the H2 blocker.

Swallow Retevmo capsules whole. Do not chew or crush the tablets.

• Do not give Retevmo capsules to your child if they cannot swallow a capsule. 

If you vomit after taking a dose, do not take an extra dose. Take the next dose at your scheduled time.

• Do not take a missed dose unless it is more than 6 hours until your next scheduled dose.
• If you take too much Retevmo, call your healthcare provider or go to the nearest hospital emergency room right away.

Dosing information

Usual Retevmo dose for adults and adolescents over the age of 12

• Less than 50 kg: 120 mg, 2 times daily (approximately every 12 hours).
• 50 kg or greater: 160 mg, 2 times daily (approximately every 12 hours).

Usual Retevmo dose for children aged 2 years to less than 12 years

Dosage is based on body surface area.

• 0.33 to 0.65 m²: 40 mg, 3 times daily
• 0.66 to 1.08 m²: 80 mg, 2 times daily
• 1.09 to 1.52 m²: 120 mg, 2 times daily
• At least 1.53 m²: 160 mg, 2 times daily.

What other drugs will affect Retevmo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Certain other medicines may affect how Retevmo works.

You should avoid taking the following medicines during treatment with Retevmo:

• St. John’s wort
• proton pump inhibitors (PPIs such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole)
• H2 blockers (such as famotidine, nizatidine, and cimetidine), and
• antacids that contain aluminum, magnesium, calcium, simethicone, or buffered medicines.

If you cannot avoid taking PPIs, H2 blockers, or antacids, see How should I take Retevmo? for more information on how to take Retevmo with these medicines.

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

How should I store Retevmo?

• Store Retevmo capsules at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
• Keep all medicines out of the reach of children and pets.

What are the ingredients in Retevmo?

Active ingredient: selpercatinib

Inactive ingredients (capsules): colloidal silicon dioxide and microcrystalline cellulose.

• 40 mg capsule shell: gelatin, titanium dioxide, ferric oxide black and black ink.
• 80 mg capsule shell: gelatin, titanium dioxide, FD&C blue #1 and black ink.
• Black ink: shellac, potassium hydroxide, and ferric oxide black.

Inactive ingredients (tablets): croscarmellose sodium, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and sodium stearyl fumarate.

• Tablet film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.
• Film coating of 40 mg, 80 mg, and 120 mg tablets: ferrosoferric oxide.
• Film coating of 80 mg, 120 mg, and 160 mg tablets: ferric oxide. 

Available as:

• Capsules: 40mg, 80mg
• Tablets: 40mg, 80mg, 120mg, 160mg.

What is Rexulti?

Rexulti is an antipsychotic used to treat major depressive disorder, schizophrenia, or agitation associated with dementia due to Alzheimer’s disease. It is an oral tablet that is taken once a day.

Rexulti’s mechanism of action involves adjusting the imbalance of natural chemicals in the brain (also called neurotransmitters), such as dopamine and serotonin. These neurotransmitters help cells to send messages to each other. An imbalance of these natural chemicals is thought to be associated with several psychiatric conditions, including schizophrenia, depression, and agitation associated with dementia due to Alzheimer’s disease .

Rexulti (brexpiprazole) first gained FDA approval on July 10, 2015. Rexulti belongs to the drug class called atypical antipsychotics.

Rexulti is available as a generic under the name brexpiprazole. The brexpiprazole generic is only approved for depression and schizophrenia in adults, whereas the brand Rexulti is also approved for adolescents aged 13 and older with schizophrenia and for dementia-related agitation in Alzheimer’s disease.

Rexulti uses

Rexulti is an atypical antipsychotic used:

• along with antidepressant medicines to treat major depressive disorder (MDD) in adults
• to treat schizophrenia in adults and children aged 13 years and older
• to treat agitation that may happen with dementia due to Alzheimer’s disease.

Rexulti should not be used as an “as-needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

It is not known if Rexulti is safe and effective for the treatment of MDD in children or the treatment of schizophrenia in children under 13 years of age.

Rexulti side effects

The most common side effects of Rexulti are:

• weight gain
• sleepiness
• dizziness
• common cold symptoms
• restlessness or feeling like you need to move (akathisia).

Serious side effects and warnings

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

Increased risk of death in elderly people with dementia-related psychosis. Medicines like Rexulti can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Rexulti is not approved for dementia-related psychosis without agitation that may happen with Alzheimer’s disease.

Increased risk of suicidal thoughts and actions. Rexulti and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

• Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when Rexulti or the antidepressant medicine is started or when the dose is changed.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worsening depression
• new or worsening anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worsening irritability
• acting aggressively, being angry, or being violent
• acting on dangerous impulses
• an extreme increase in activity or talking (mania)
• other unusual changes in behavior or mood.

Other serious side effects of Rexulti include the following.

Cerebrovascular problems (these involve the blood vessels of the brain), including stroke, in elderly people with dementia-related psychosis, that can lead to death.

Neuroleptic malignant syndrome (NMS), a rare and life-threatening reaction to antipsychotic drugs. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever
• stiff muscles
• confusion
• changes in your pulse, blood pressure, heart rate, and breathing
• increased sweating.

Uncontrolled body movements (tardive dyskinesia). Rexulti may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Rexulti. Tardive dyskinesia may also start after you stop taking Rexulti.

Rexulti may also cause problems with your metabolism such as:

• High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Rexulti. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start Rexulti and then regularly during long-term treatment with Rexulti. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Rexulti:
  • feel very thirsty
  • feel very hungry
  • feel sick to your stomach
  • need to urinate more than usual
  • feel weak or tired
  • feel confused, or your breath smells fruity
• Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start Rexulti, and then periodically during treatment with Rexulti.
• Weight gain. You and your healthcare provider should check your weight before you start and often during treatment with Rexulti.

Unusual and uncontrollable (compulsive) urges. Some people taking Rexulti have had strong, unusual urges to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusually strong urges or behaviors, talk to your healthcare provider.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Rexulti.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position.

Falls. Rexulti may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions). Rexulti may increase your risk of seizures.

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking Rexulti?”

Difficulty swallowing that can cause food or liquid to get into your lungs.

Sleepiness, drowsiness, feeling tired, difficulty thinking, and doing normal activities. See “What should I avoid while taking Rexulti?”

Rexulti may harm an unborn baby.

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

Before taking

Do not take Rexulti if you are allergic to Rexulti, Rexulti, or any inactive ingredient in the tablets.

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

• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
• have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had a low white blood cell count
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Rexulti may harm your unborn baby. Taking Rexulti during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Rexulti during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Rexulti.

There is a pregnancy exposure registry for women who are exposed to Rexulti during pregnancy. If you become pregnant during treatment with Rexulti, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.

Breastfeeding

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

How should I take Rexulti?

Take Rexulti exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose if needed. Do not change the dose or stop taking Rexulti without first talking to your healthcare provider.

• Take Rexulti 1 time each day.
• Rexulti may be taken with or without food.

Dosing information

The dosage of Rexulti varies depending on the condition being treated and the age of the patient.

The dosage may need to be adjusted for moderate to severe liver disease, kidney disease, and interacting medications.

Dose of Rexulti for Major Depressive Disorder (Adults)

• Starting dose: 0.5 to 1 mg daily
• Target dose: 2 mg daily
• Maximum dose: 3 mg daily

Dose of Rexulti for Schizophrenia (Adults)

• Starting dose: 1 mg daily
• Target dose: 2 to 4 mg daily
• Maximum dose: 4 mg daily

Dose of Rexulti for Schizophrenia (Children 13 to 17 years)

• Starting dose: 0.5 mg daily
• Target dose: 2 to 4 mg daily
• Maximum dose: 4 mg daily

Dose of Rexulti for Agitation Associated With Dementia

• Starting dose: 0.5 mg daily
• Target dose: 2 mg daily
• Maximum dose: 3 mg daily

What should I avoid while taking Rexulti?

Do not drive a car, operate machinery, or do other dangerous activities until you know how Rexulti affects you. Rexulti may make you feel drowsy.

Do not become too hot or dehydrated during treatment with Rexulti.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water.

What happens if I take too much Rexulti?

If you take too much Rexulti, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

What other drugs affect Rexulti?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rexulti and other medicines may affect each other causing possible serious side effects. Rexulti may affect the way other medicines work, and other medicines may affect how Rexulti works. Especially tell your healthcare provider if you take:

• Strong CYP2D6 or CYP3A4 inhibitors, such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, paroxetine, fluoxetine, or bupropion. Administer half the recommended dosage of Rexulti
• Strong/moderate CYP2D6 with strong/moderate CYP3A4 inhibitors: Administer one-quarter of the recommended dosage of Rexulti
• strong/moderate CYP3A4 inhibitors, and you are a known CYP2D6 poor metabolizer: Administer one-quarter of the recommended dosage of Rexulti
• Strong CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, or glucocorticoids. Double the recommended dosage of Rexulti and further adjust based on the clinical response.

Your healthcare provider can tell you if it is safe to take Rexulti with your other medicines. Do not start or stop any medicines during treatment with Rexulti without first talking to your healthcare provider. 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 Reyvow?

Reyvow is a serotonin (5-HT) 1F receptor agonist.

Reyvow is used in adults to treat migraine headaches with or without aura.

Reyvow will only treat and will not prevent migraine headache.

Warnings

Reyvow is a federally controlled substance (CV) because it contains lasmiditan that can be a target for people who abuse prescription medicines or street drugs.

Keep this medicine in a safe place to protect it from theft. Never give your Reyvow to anyone else, because it may harm them. Selling or giving away Reyvow is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Do not take more than one dose in a 24-hour period.

For at least 8 hours after taking Reyvow, do not drive and avoid other hazardous activity.

Before taking this medicine

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

• an allergy to lasmiditan;
• liver disease;
• slow heartbeats;
• high blood pressure; or
• drug addiction.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with lasmiditan and cause a serious condition called serotonin syndrome.

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

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether lasmiditan will harm an unborn baby. However, having migraine headaches during pregnancy may cause complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating migraines may outweigh any risks to the baby.

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

How should I take Reyvow?

Take Reyvow exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Reyvow may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take Reyvow soon as you notice headache symptoms.

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

Do not take more than one dose in a 24-hour period.

You may take this medicine with or without food.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Call your doctor if your headache does not go away completely, or if you have more than 4 headaches in one month (30 days).

Store at room temperature away from moisture and heat.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Dosing information

Usual Adult Dose for Migraine:

Initial dose: 50 mg, 100 mg, or 200 mg orally once
Maximum dose: 1 dose per day

Comments:
-This drug should not be taken unless the patient can wait 8 hours or more before driving or operating machinery.
-No more than 1 dose should be taken in 24 hours; a second dose has not been shown to be effective for the same migraine attack.
-The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
-This drug is not indicated for the prevention of migraine attacks.

Use: For the acute treatment of migraine with or without aura.

What happens if I miss a dose?

Since Reyvow is used once when needed, it does not have a daily dosing schedule. Call your doctor if your migraine symptoms do not improve after using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

After taking Reyvow, do not drive for at least 8 hours, and avoid other hazardous activity. Your reactions could be impaired, and you may not realize the extent of that impairment.

Drinking alcohol with this medicine can cause side effects.

Reyvow side effects

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Reyvow side effects may include:

• dizziness, drowsiness;
• feeling tired; or
• numbness or tingling.

What is rifampin?

Rifampin is an antibiotic that is used to treat or prevent tuberculosis (TB).

Rifampin may also be used to reduce certain bacteria in your nose and throat that could cause meningitis or other infections. Rifampin prevents you from spreading these bacteria to other people, but rifampin will not treat an active meningitis infection.

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

Rifampin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, rash, feeling light-headed, wheezing, 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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

• severe stomach pain, diarrhea that is watery or bloody;
• chest pain, cough, shortness of breath;
• a light-headed feeling, like you might pass out;
• easy bruising, unusual bleeding (nosebleeds, bleeding gums);
• pounding heartbeats or fluttering in your chest;
• flu symptoms–fever, chills, body aches, headache, weakness, nausea, vomiting; or
• liver problems–upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of rifampin may include:

• red discoloration of your teeth, sweat, urine, saliva, and tears;
• heartburn, gas, upset stomach, loss of appetite;
• nausea, vomiting, diarrhea;
• fever;
• headache, dizziness, drowsiness, tiredness;
• muscle weakness, pain in your arms or legs;
• problems with balance or muscle movement;
• numbness; or
• confusion, changes in behavior, trouble concentrating.

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

Warnings

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Before taking this medicine

You should not use rifampin if you are allergic to rifampin or similar medicines such as rifabutin, rifapentine, rifamycin, or rifaximin.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with rifampin. Your doctor may change your treatment plan if you also use: atazanavir, darunavir, fosamprenavir, praziquantel, ritonavir, saquinavir, or tipranavir.

Tell your doctor if you have ever had:

• diabetes;
• liver disease;
• bleeding problems; or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

It is not known whether this medicine will harm an unborn baby. However, using rifampin during the last few weeks of pregnancy may cause bleeding in the mother or the newborn baby. Tell your doctor if you are pregnant.

Rifampin can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using rifampin, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

You should not breastfeed while using this medicine.

How should I use rifampin?

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

Rifampin oral is taken by mouth. Rifampin injection is given as an infusion into a vein.

Take rifampin oral on an empty stomach, at least 1 hour before or 2 hours after a meal. Take each dose with a full glass of water.

A healthcare provider will give you rifampin injection. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when rifampin is injected.

Rifampin may cause temporary discoloration of your teeth, sweat, urine, saliva, and tears (a yellow, orange, red, or brown color). This side effect is usually not harmful. However, soft contact lenses may be permanently stained if you wear them while using rifampin.

Dark colored urine can be a sign of liver problems. Call your doctor if you have reddish-brown urine together with upper stomach pain, loss of appetite, and jaundice (yellowing of your skin or eyes).

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may increase your risk of further infection that is resistant to antibiotics. Rifampin will not treat a viral infection such as the flu or a common cold.

You should not stop using rifampin without your doctor’s advice. Stopping the medicine suddenly and later starting again may cause kidney problems. Rifampin is usually given until lab tests show that the infection has cleared.

While using rifampin, you may need frequent blood tests.

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

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?

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 can cause worsening symptoms such as nausea, vomiting, stomach pain, itching, headache, lack of energy leading to loss of consciousness, and dark or discolored skin, saliva, tears, urine, or stools.

What should I avoid while using rifampin?

Avoid drinking alcohol. It may increase your risk of liver damage.

What is rifaximin?

Rifaximin is used to treat travelers’ diarrhea caused by Escherichia coli (E. coli) in adults and children who are at least 12 years old. Most people get this infection by eating food or drinking fluids that have been contaminated with the E. coli bacteria.

Rifaximin is also used to treat irritable bowel syndrome (IBS) in adults whose main symptom is diarrhea.

Rifaximin is also used to lower the risk of a decline in brain function in adults with liver failure. Brain function can be affected when the liver stops working and cannot remove toxic substances from the body.

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

Rifaximin 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.

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

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• fever; or
• fluid build-up around the stomach–rapid weight gain, stomach pain and bloating, trouble breathing while lying down.

Common side effects of rifaximin may include:

• swelling in your hands or feet;
• nausea;
• headache, dizziness;
• tiredness; or
• abnormal liver function tests.

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 take rifaximin if you are allergic to rifaximin, rifabutin, rifampin, or rifapentine.

Tell your doctor if you have ever had:

• liver disease;
• diarrhea with a fever; or
• watery or bloody diarrhea.

Tell your doctor if you are pregnant or breastfeeding.

Rifaximin should not be given to a child younger than 12 years old.

How should I take rifaximin?

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

You may take rifaximin with or without food.

For travelers’ diarrhea, rifaximin is usually taken for only 3 days. For IBS, rifaximin is usually taken for 2 weeks at a time. Follow your doctor’s dosing instructions very carefully.

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. Rifaximin will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Call your doctor if your symptoms do not improve after 24 to 48 hours, or if they get worse while using rifaximin.

Rifaximin does not treat all bacterial forms of travelers’ diarrhea.

Store at room temperature away from moisture and heat.

Rifaximin dosing information

Usual Adult Dose for Traveler’s Diarrhea:

200 mg orally 3 times a day for 3 days

Comments:
-This drug should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea caused by pathogens other than Escherichia coli.

Use: For the treatment of travelers’ diarrhea due to noninvasive strains of E coli

Usual Adult Dose for Hepatic Encephalopathy:

550 mg orally twice a day

Comments:
-In trials, lactulose was used concomitantly in 91% of patients; differences in treatment effect of patients not using concomitant lactulose could not be assessed.

Use: For reduction in risk of overt hepatic encephalopathy recurrence

Usual Adult Dose for Irritable Bowel Syndrome:

550 mg orally 3 times a day for 14 days

Comments:
-If symptoms recur, patients can be retreated up to 2 times with the same dosage regimen.

Use: For the treatment of irritable bowel syndrome with diarrhea

Usual Pediatric Dose for Traveler’s Diarrhea:

12 years or older: 200 mg orally 3 times a day for 3 days

Comments:
-This drug should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea caused by pathogens other than E coli.

Use: For the treatment of travelers’ diarrhea due to noninvasive strains of E coli

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 rifaximin?

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.

What is rimegepant?

Rimegepant is a prescription medicine used by adults to treat migraines (with or without aura) when they occur and also to prevent episodic migraines. Rimegepant works to reduce migraine symptoms of headache, nausea, vomiting, light sensitivity and sound sensitivity, by blocking CGRP receptors. This medicine may reduce the number of monthly migraine days when taken to prevent episodic migraines.

Rimegepant is an orally disintegrating tablet (ODT) that dissolves in the mouth without the need to take it with a glass of water. Because the tablet dissolves in the mouth it is absorbed into the bloodstream quickly, with the highest blood concentrations reached after one and a half hours.

Warnings

It is not known if it is safe to take rimegepant ODT for more than 15 migraine headaches in 30 days.

Rimegepant ODT can be taken 1 time each day as needed. You should not take more than 1 tablet in 24 hours.

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.

If you take too much rimegepant ODT, go to the nearest emergency room right away.

Before taking this medicine

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

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

• liver disease; or
• kidney disease (or if you are on dialysis).

It is not known whether rimegepant will harm an unborn baby. However, having migraine headaches may cause complications during pregnancy such as dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of treating migraines may outweigh any risks to the baby.

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

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

How should I take rimegepant?

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

Call your doctor if your symptoms do not improve, or if you have more than 15 headaches in one month (30 days).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine.

• Use dry hands when opening the blister pack.
• Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
• As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
• The ODT will disintegrate in saliva so that it can be swallowed without additional liquid.
• Swallow several times as the tablet dissolves.
• Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.

Store at cool room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Migraine:

75 mg orally
Maximum dose: 75 mg in a 24-hour period

Comments:
-This drug is not for the preventive treatment of migraine.
-The safety of treating more than 15 migraines in a 30-day period is unknown.

Use: For the acute treatment of migraine with or without aura.

Place on tongue (or under tongue) and allow to disintegrate in saliva and swallow; additional liquid is not necessary. Do not take more than 1 dose in 24-hours.

What happens if I miss a dose?

Since rimegepant is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Rimegepant side effects

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

An allergic reaction can be severe, and may occur days after you have taken this medicine.

What is Rinvoq?

Rinvoq (upadacitinib) is an oral Janus kinase (JAK) inhibitor that may be used alone or in combination with other medications to treat several conditions that have inflammation as a characteristic symptom. It works by decreasing the activity of the immune system. Rinvoq is used to treat:

• Rheumatoid arthritis in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s)
• Psoriatic arthritis (a condition that causes joint pain and swelling, and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s)
• Symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition, or whose eczema has not responded to other medications
• Ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults who cannot take or who did not respond to one or more TNF inhibitor medication(s)
• Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Giant cell arteritis (an inflammatory condition of the temporal arteries) in adults
• Active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling), but without changes seen on X-ray, in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Active polyarticular juvenile idiopathic arthritis in children 2 years and older who have had an inadequate response or intolerance to one or more TNF blockers.

There are two formulations of Rinvoq: Rinvoq extended-release tablets and Rinvoq LQ liquid solution. These two formulations are not interchangeable. Rinvoq is not a substitute for Rinvoq LQ.

• Rinvoq is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine.

Rinvoq was FDA approved on August 16, 2019, and Rinvoq LQ was approved on April 26, 2024. 

What is the cost of Rinvoq?

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 Rinvoq.

You may also be eligible for a Rinvoq savings card or Rinvoq coupon. Ask your doctor or pharmacist if you qualify.

Rinvoq side effects

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

Upadacitinib affects your immune system and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

• fever, swollen glands, night sweats;
• vomiting, diarrhea, weight loss;
• a new skin lesion, or a mole that has changed in size or color;
• weakness on one side of your body, problems with speech or vision;
• changes in your mental state;
• blood in your urine, burning when you urinate, little or no urination; or
• tenderness near the transplanted kidney.

Some people taking Rinvoq have developed heart attacks, strokes, or serious blood clots. Seek emergency medical attention if you have:

• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or
• signs of a blood clot deep in the body – pain, swelling, or warmth in one leg.

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

• wheezing, trouble breathing, severe or worsening cough;
• increased urination, pain, or burning when you urinate;
• fever, chills, cough with mucus, chest pain, feeling short of breath;
• abnormal blood tests;
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired;
• signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body;
• symptoms of herpes virus – cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• a hole (perforation) in your digestive tract – fever, severe stomach pain, change in bowel habits; or
• signs of hepatitis – loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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

Common Rinvoq side effects may include:

• flu symptoms or fever;
• nausea;
• acne or a rash;
• headache;
• stomach pain;
• weight gain;
• muscle pain;
• folliculitis (redness or crusting around your hair follicles);
• cold symptoms such as stuffy nose, sneezing, sore throat;
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough; or
• low red blood cells (anemia) – pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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

Warnings

Rinvoq carries a Boxed Warning for serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis.

Taking Rinvoq may increase your risk of life-threatening medical problems, including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. A higher rate of serious infections was observed with Rinvoq 30 mg tablets compared to 15 mg tablets.

Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea, or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.

Seek emergency medical attention if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.

If you’ve had hepatitis B, it may come back or get worse. Tell your doctor if you don’t feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not take Rinvoq if you are allergic to upadacitinib, Rinvoq, or any excipients in the tablets or oral solution.

Before you start taking Rinvoq, tell your doctor if you have any signs of infection, such as fever, sweating, chills, cough, body aches, tiredness, open sores or skin wounds, shortness of breath, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

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

• a weak immune system or HIV;
• an active or chronic infection;
• tuberculosis (or if anyone in your household has tuberculosis);
• herpes zoster (also called shingles);
• any type of cancer;
• diverticulitis, an ulcer in your stomach or intestines, or unexplained stomach pain;
• heart problems, heart attack, stroke, or blood clot;
• high cholesterol;
• chronic lung disease;
• eye problems (especially a problem with your retina);
• diabetes;
• low red or white blood cell counts;
• recently received or scheduled to receive any vaccine;
• are a current or past smoker;
• liver disease (especially hepatitis B or C); or
• kidney disease
• are pregnant or intending to become pregnant
• are breastfeeding.

Make sure you are current on all vaccines before you start using Rinvoq.

Using Rinvoq may increase your risk of developing certain cancers, such as lymphoma, lung cancer, or skin cancer. Ask your doctor about this risk.

Pregnancy

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

May harm an unborn baby. Use effective birth control while using Rinvoq and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

There is a pregnancy surveillance program for Rinvoq. The program’s purpose is to collect information about your and your baby’s health.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 6 days after your last dose.

How should I take Rinvoq?

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

Rinvoq tablets

Rinvoq tablets are usually taken once per day, with or without food.

• Swallow the tablet whole and do not crush, chew, or break a tablet.
• Call your doctor if you see part of the Rinvoq tablet in your stool.
• You may need frequent medical tests before and while taking Rinvoq.

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

Rinvoq LQ

Rinvoq LQ is not the same as Rinvoq tablets. Do not switch between Rinvoq LQ and Rinvoq tablets.

Your healthcare provider will tell you what dose to give. This is based on you or your child’s weight. The dosage is usually given twice daily.

• Only use the syringe provided. Do not share with other people or use with other medicines. The syringe should be clean and dry before use.
• The first time you use a new bottle of Rinvoq LQ, you will need to insert the syringe adapter. Once inserted, do not remove.
• Insert the syringe tip into the adapter, then turn the bottle upside down.
• Pull the plunger down and flick the syringe to remove large air bubbles. Small air bubbles are normal.
• Measure the dose. Move the plunger until it is even with the marking for the dose.
• Turn the bottle upright, carefully remove the syringe, and place the lid back on the bottle.
• Check that the dose is correct. If correct, place the syringe against the inside of your child’s cheek and push the plunger to give the entire dose into the child’s mouth. The solution must be given within 1 hour of filling the syringe.
• Give the child a drink of water.
• Remove the plunger from the syringe and rinse both parts in water, then leave to dry.

Dosing Information

Dose of Rinvoq for Rheumatoid Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis (Adults)

• 15 mg orally once a day

Rinvoq may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

• Not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) of less than 1000 cells/mm³, or hemoglobin level of less than 8 g/dL.

Dose of Rinvoq for Psoriatic Arthritis

• Adults: 15 mg orally once daily
• Children aged 2 to less than 18 years weighing at least 10 kg: the dosage is based on body weight.

Dose of Rinvoq for Atopic Dermatitis

• Adults less than 65 years and children 12 years and older weighing at least 40kg:
  • Initiation dose: 15 mg orally once daily
  • Maximum dose: 30 mg orally once daily (if no response with the initial dose).
• Adults 65 years and older: 15 mg once daily.
• Severe renal impairment: 15 mg once daily. 

Use the lowest dose to maintain the response.

• Not recommended to use in combination with other JAK inhibitors, biological immunomodulators, or other immunosuppressants.

Dose of Rinvoq for Ulcerative Colitis (Adults)

• Induction dose: 45 mg once daily for 8 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment, or with
    drug interactions. 

Dose of Rinvoq for Crohn’s Disease (Adults)

• Induction dose: 45 mg once daily for 12 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment or with
    drug interactions. 

Dose of Rinvoq for Polyarticular Juvenile Idiopathic Arthritis

• The recommended dosage is based on body weight.

Dose of Rinvoq for Giant Cell Arteritis (Adults)

• Adults: 15 mg orally once daily in combination with a tapering dose of corticosteroids.
• Can be used as monotherapy following discontinuation of corticosteroids.

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?

 If you take too much Rinvoq/Rinvoq LQ, call your healthcare provider or Poison Help line or go to the nearest hospital emergency room. 

What should I avoid while taking Rinvoq?

Avoid receiving a “live” vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What is risdiplam?

Risdiplam is used to treat a genetic condition called spinal muscular atrophy in children and adults.

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

Risdiplam 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.

Serious side effects may be more likely, or you may have none at all.

Common side effects of risdiplam may include:

• fever, cough, or lung infection;
• vomiting, diarrhea, constipation;
• rash; 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.

Warnings

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

Before taking this medicine

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

May harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using risdiplam and for at least 1 month after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.

It may be harder for you to get a woman pregnant while you are using risdiplam.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take risdiplam?

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

Doses are based on age and weight. Your dose may change if you gain or lose weight.

You may take risdiplam with or without food, but take it the same time each day.

Swallow the tablet whole with water and do not crush, chew, or break it.

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

To make sure you swallow the entire dose of liquid medicine, drink a glass of water after taking the medicine.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you are breastfeeding a child using liquid medicine, give this medicine to a child before or after feeding. Do not mix risdiplam liquid with infant formula or milk.

If the entire dose is not swallowed or if you vomit shortly after taking risdiplam, do not take another dose. Take your next dose as scheduled.

If you are unable to swallow table whole, read and carefully follow the instructions provided to you on how to prepare and take risdiplam. Risdiplam liquid may also be given through a feeding tube. Ask a doctor or pharmacist if you do not understand these instructions.

Do not change your dose or stop using a medicine without your doctor’s advice.

Do not use liquid medicine in powder form. If you receive the medicine as a powder, ask your pharmacist to mix the medicine for you.

Store the tablet in the original container tightly closed at room temperature, away from moisture and heat. Ask your pharmacist how to properly store the liquid medicine and the reusable oral syringes.

Risdiplam dosing information

Usual Adult Dose for Spinal Muscular Atrophy:

5 mg orally once a day

Comments:
-See Other Comments or Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy

Usual Pediatric Dose for Spinal Muscular Atrophy:

Less than 2 months: 0.15 mg/kg orally once a day

2 months to less than 2 years: 0.2 mg/kg orally once a day

2 years and older:
-Weight less than 20 kg: 0.25 mg/kg orally once a day
-Weight 20 kg or more: 5 mg orally once a day

Comments:
-See Other Comments or Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the 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 risdiplam?

Avoid getting risdiplam in your eyes or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

What other drugs will affect risdiplam?

Other drugs may affect risdiplam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is risedronate?

Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate is for use when you have a high risk of bone fracture due to osteoporosis.

Risedronate is also used to treat Paget’s disease of bone.

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

Risedronate 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).

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

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of risedronate may include:

• heartburn, diarrhea, indigestion;
• stomach pain;
• back pain, joint pain, muscle pain; or
• flu-like symptoms.

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

Warnings

You should not take risedronate if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Risedronate can cause serious problems in the stomach or esophagus. Stop using risedronate and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Before taking this medicine

You should not take risedronate if you are allergic to it, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking risedronate.

Tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin taking risedronate);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

Talk with your doctor about the risks and benefits of using this medication.

It is not known whether this medicine will harm an unborn baby. Stop taking risedronate and tell your doctor right away if you become pregnant, or think you may be pregnant.

You should not breastfeed while using risedronate.

Risedronate should not be given to a child younger than 18 years old.

How should I take risedronate?

Risedronate tablets come in different strengths (number of milligrams per pill) that are taken on different schedules. You may need to take a tablet once per day, once per week, once per month, or for 2 days in a row once per month.

Your dosing schedule will depend on why you are taking risedronate and in what tablet strength. If you change strengths, you may also need to change your schedule.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Risedronate is often given for only 3 to 5 years.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water when taking a risedronate tablet. Do not use coffee, tea, soda, juice, or mineral water.

Do not crush, chew, or suck on a risedronate tablet. Swallow it whole.

For at least 30 minutes after taking risedronate:

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, iron, antacids, or laxatives.

Take this medicine at the same time each day or on the same day each week or each month (depending on your dosing schedule).

Pay special attention to your dental hygiene while taking risedronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

What happens if I miss a dose?

Once-daily dosing: If you forget to take risedronate first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week or once-per-month dosing: If you forget to take risedronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly or monthly schedule on your chosen dose day. Do not take 2 doses in one day.

Call your doctor for instructions if you miss more than 2 doses in a month.

What happens if I overdose?

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line

What should I avoid while taking risedronate?

Do not take two different brands or strengths of risedronate at the same time.

Avoid taking any other medicines for at least 30 minutes after taking risedronate. This includes vitamins, calcium, iron, antacids, or laxatives. Some medicines can make it harder for your body to absorb risedronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.