LISRAYA

BREPOCITINIB (BREP oh SYE ti nib) treats dermatomyositis, an autoimmune condition that causes muscle weakness and skin rash. It works by slowing down an overactive immune system. This decreases symptoms.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.
Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medication with any of the following:
-Dofetilide
-Live virus vaccines
This medication may also interact with the following:
-St. John's wort
-Tobacco
This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.
You may need blood work done while you are taking this medication.
This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.
Your care team will screen you for tuberculosis (TB) before you start this medication. If they think you are at risk, you may be treated with medication for TB. You should start taking the medication for TB before you start this medication. Make sure to finish the full course of TB medication.
Talk to your care team about your vaccination history. You should not receive live vaccines while you're being treated with this medication and until your care team tells you that your immune system is no longer weakened. You may need to get some vaccines before you start treatment. If you need a non-live vaccine while you are being treated, talk to your care team.
Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Tobacco use may increase your risk of cancer. Talk to your care team about having your skin checked for cancer while taking this medication. Limit the amount of time you spend in the sun. Wear protective clothing and sunscreen when you are in the sun. Do not use sun lamps, tanning beds, or tanning booths.
This medication may increase the risk of blood clots, heart attack, stroke, or death. High blood pressure, high cholesterol, diabetes, increased age, excess weight, and tobacco use increase this risk. Call emergency services right away if you have symptoms of a heart attack or stroke.
This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.
If you have diabetes, your care team may ask you to check your blood sugar (glucose) more often while you are taking this medication. This medication can cause low blood sugar in people with diabetes. Know the symptoms of low blood sugar. Know what to do if it happens. Always carry a source of quick sugar with you, such as glucose tablets, candy, or juice. Signs of low blood sugar may include tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, and rapid heartbeat.
Talk to your care team if you may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 3 days after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 3 days after the last dose. Your care team can help you find the option that works for you.
Do not breastfeed while taking this medication and for 3 days after the last dose.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
-Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
-Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
-Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
-Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
-Stomach pain that is severe, does not go away, or gets worse
-Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Diarrhea
-Fatigue
-Headache
-Joint pain
-Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Store below 30 degrees C (86 degrees F). Get rid of any unused medication after the expiration date.
To get rid of medications that are no longer needed or have expired:
-Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.