Brepocitinib

Brepocitinib is used in adults to treat dermatomyositis (a disease that causes swelling in the muscles and skin).

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

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

Brepocitinib is usually taken once daily with or without food.

Before you take brepocitinib, your doctor will test you for tuberculosis (TB) and hepatitis. You may need treatment for TB before starting brepocitinib. Your doctor will watch for TB during and after treatment, even if your first test is negative.

Your doctor will check your blood cell counts and liver function before and during treatment. Your cholesterol should be checked about 12 weeks after you start brepocitinib and as needed.

Serious infections may be fatal. Further doses may be delayed until a serious infection clears up. Your doctor may also stop treatment for a time if you have abnormal blood tests.

If you have diabetes, brepocitinib may lower your blood sugar. Your doctor may tell you to check it more often.

Follow your doctor's advice about having your skin checked for cancer.

Store at room temperature away from moisture and heat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away for fever, chills, cough, or painful urination.

Brepocitinib may raise your risk of cancer, blood clots, heart attack, or stroke. Get emergency medical help for chest pain, sudden shortness of breath, weakness on one side, or slurred speech.

Brepocitinib may cause a hole or tear in your stomach or intestines. Get medical help right away for new stomach pain, fever, chills, nausea, or vomiting.

You should not use brepocitinib if you are allergic to it or any of its ingredients.

Do not start brepocitinib if you have an infection unless your doctor says it is okay.

Tell your doctor if you have or have ever had:

• an active or chronic infection, or infections that keep coming back;
• tuberculosis (TB), or close contact with someone who has TB;
• herpes zoster (also called shingles);
• HIV or a weak immune system (caused by disease or by using certain medicine);
• chronic lung disease;
• diabetes;
• any type of cancer;
• a blood clot, stroke, heart attack, or other heart problems;
• anemia (low red blood cells) or low white blood cell (WBC) counts;
• unexplained stomach pain, diverticulitis, or ulcers in your stomach or intestines;
• currently smoke (smoking may reduce the effectiveness of this drug) or used to smoke; or
• liver or kidney disease, including hepatitis B or C.

Tell your doctor where you live or have lived and where you have traveled. Tuberculosis and some fungal infections are more common in certain parts of the world.

Tell your doctor if you recently received a vaccine or are scheduled to receive one. Make sure you are current on all vaccines before you start using brepocitinib.

Using brepocitinib may increase your risk of developing cancer, including lymphoma, lung cancer, and skin cancer. Current or past smokers may have a higher risk. Ask your doctor about your individual risk and skin symptoms to watch for.

Brepocitinib may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you can become pregnant, your doctor will check for pregnancy before treatment. Use effective birth control while using brepocitinib and for 3 days after your last dose. Tell your doctor right away if you become pregnant or think you are pregnant.

Your pregnancy may be reported to a safety study if you become pregnant while taking brepocitinib. The study tracks effects on you and your baby.

Do not breastfeed while using brepocitinib, and for 3 days after your last dose.

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

Some people taking brepocitinib have developed heart attacks, strokes, or serious blood clots. Stop using brepocitinib and 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; or
• signs of a blood clot--swelling, pain, warmth, or tenderness in an arm or leg, shortness of breath, sudden unexplained chest or upper back pain, fast or irregular heartbeat, coughing up blood, dizziness, lightheadedness, or fainting.

JAK medicines such as brepocitinib, may raise the risk of death in people 50 or older who have at least 1 heart disease risk factor.

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

• signs of infection--fever, sweating, chills, cough, shortness of breath, blood in your mucus, warm, red, or painful skin or sores, muscle aches, tiredness, diarrhea, stomach pain, weight loss, burning when you urinate, or urinating more often than usual;
• a hole or tear in your stomach or intestines--new stomach pain, fever, chills, nausea, or vomiting (get medical help right away);
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
• signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body.

Brepocitinib may lower blood cell counts or raise liver enzymes and cholesterol.

Common side effects of brepocitinib may include:

• cold or flu symptoms, sinus infections, or bronchitis;
• headache, tiredness, joint or back pain;
• urinary tract infection;
• nausea or diarrhea;
• falls; or
• acne.

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

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving a "live" vaccine while you are being treated or right before starting treatment with brepocitinib. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others. Tell anyone giving you a vaccine that you take brepocitinib.

Limit your time in sunlight. Avoid tanning beds and sunlamps. Wear protective clothing and use broad-spectrum sunscreen (SPF 30 or higher) when you are outdoors.

Do not take brepocitinib with another JAK inhibitor, another TYK2 inhibitors or any other biologic medicine for arthritis or other immune system diseases.

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

• drugs that weaken immune system;
• medicines to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders;
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• steroids.

This list is not complete and many other drugs may affect brepocitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.