Brepocitinib

Brepocitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection including those caused by bacteria, viruses, or fungi. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), a lung disease, hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV; an ongoing liver infection), or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi River valleys or the Southwest where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system. Make sure you have discussed any medications you are currently taking or plan to take with your doctor and pharmacist before starting brepocitinib.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; coughing up bloody mucus; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; urination that is frequent, painful, or causes a burning feeling; diarrhea; stomach pain; or excessive tiredness.

You may be infected with tuberculosis (TB, a type of lung infection), but not have any symptoms of the disease. In this case, brepocitinib may increase the risk that your infection will become more serious and that you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medicine to treat this infection before you begin using brepocitinib. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever.

Brepocitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers such as skin cancer. Tell your doctor if you have or have ever had any type of cancer or if you are a current or past smoker. Your doctor will check your skin during your treatment with topical brepocitinib for signs of skin cancer.

Brepocitinib may increase the risk of serious and potentially fatal heart-related events such as heart attack or stroke. Tell your doctor if you are a current or past smoker, or have had a heart attack or other heart problems. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; pain in arms, back, neck, jaw, or stomach; sudden, severe headache; cold sweat; sudden, severe nausea or vomiting; speech problems; dizziness or faintness; or weakness or numbness of an arm or a leg.

Brepocitinib may increase the risk of serious and possibly life-threatening blood clot in the lungs or legs. Tell your doctor if you have or have ever had a blood clot in your legs or lungs. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; cough; pain, warmth, redness, swelling, or leg tenderness; cold sensation in the arms, hands, or legs; or muscle pain.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. Talk to your doctor about the risks of taking brepocitinib.

Brepocitinib is used to treat dermatomyositis (condition that involves muscle inflammation and a skin rash). Brepocitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

Brepocitinib comes as a tablet to take by mouth. Take with or without food once a day. Take brepocitinib at around the same time every day.

Take brepocitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to temporarily or permanently stop treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking brepocitinib,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with brepocitinib. Other medications may cause dosing changes or extra monitoring when taken with brepocitinib. Make sure you have discussed any medications you are currently taking or plan to take before starting brepocitinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking brepocitinib, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with brepocitinib: ibuprofen, naproxen, aspirin, St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking brepocitinib. Do not start any of these medications while taking brepocitinib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had ulcers in your stomach or intestines, diverticulitis (inflammation of small pouches that can form in the lining of the bowels), diabetes, anemia (a lower than normal number of red blood cells), high cholesterol, or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking brepocitinib. You may have to take a pregnancy test before starting treatment. You should use effective birth control to prevent pregnancy during your treatment and for 3 days after your final dose. Talk to your doctor about the best birth control method for you. If you become pregnant while taking brepocitinib, call your doctor immediately. Brepocitinib may harm the fetus.
• do not breastfeed while taking brepocitinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking brepocitinib.
• ask your doctor about the safe use of alcoholic beverages while you are taking brepocitinib. Alcohol can make the side effects from brepocitinib worse.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen.
• do not have any vaccinations without talking to your doctor. Your doctor may have you receive vaccines before starting brepocitinib.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Brepocitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• tiredness
• nausea
• diarrhea
• back pain
• fall
• acne

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking brepocitinib and call your doctor immediately or get emergency medical treatment:

• rash, hives, swelling of face, eyes, lips, or throat, difficulty swallowing or breathing
• severe stomach pain
• extreme hunger; pale skin; feeling shaky or trembling; fast or fluttering heartbeat; sweating; trembling; blurred vision; or unusual anxiety
• shortness of breath, tiredness, or pale skin

Brepocitinib may cause an increase in your blood cholesterol levels. Your doctor will order tests to monitor your cholesterol levels during your treatment with brepocitinib. Talk to your doctor about the risks of taking this medication.

Brepocitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to brepocitinib.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking brepocitinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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