For U.S. Residents Only
The following are answers to questions you may have about RYDAPT® (midostaurin) capsules. It is important to also talk with your health care team about questions you may have.
RYDAPT is a prescription medicine used to treat adults with advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
It is not known if RYDAPT is safe and effective in children.
Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT.
Signs and symptoms of an allergic reaction to RYDAPT have included trouble breathing, flushing, chest pain, throat tightness, and swelling of your lips, mouth, or throat. Get medical help right away if you have any of these signs or symptoms.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Take RYDAPT exactly as your health care provider tells you.
Your health care provider will tell you how many capsules of RYDAPT you need to take. Do not change your dose unless your health care provider tells you to.
Your health care provider will prescribe medicines to help prevent nausea and vomiting during treatment with RYDAPT.
Take RYDAPT 2 times a day (about every 12 hours apart). Take RYDAPT with food.
Do not open or crush RYDAPT capsules.
If you miss a dose of RYDAPT, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose. If you vomit after taking a dose of RYDAPT, do not take an extra dose. Take your next dose at your scheduled time.
RYDAPT may cause serious side effects, including lung problems. RYDAPT may cause lung problems that may lead to death when used alone or in combination with other chemotherapy medicines. Get medical help right away if you have any new or worsening lung symptoms, including cough, chest discomfort, or shortness of breath.
The most common side effects of RYDAPT in people with advanced SM include: nausea; vomiting; diarrhea; swelling of your hands, feet, or ankles; muscle or bone pain; stomach-area pain; tiredness; upper respiratory tract infection; constipation; fever; headache; and trouble breathing.
Call or inform your health care provider if nausea, vomiting, or diarrhea occurs, gets worse, or does not go away.
RYDAPT may cause fertility problems in females and males, which may affect your ability to have children. Talk to your health care provider if you have concerns about fertility.
Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking RYDAPT if you develop certain side effects during treatment with RYDAPT.
Your health care provider will do blood tests to check you for side effects during treatment with RYDAPT.
These are not all of the possible side effects of RYDAPT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Store RYDAPT at room temperature between 68°F to 77°F (20°C to 25°C). Keep RYDAPT in the original package to protect from moisture.
Keep RYDAPT and all medicines out of the reach of children.
Medicines are sometimes prescribed for conditions not listed in the Patient Information. Do not take RYDAPT for a condition for which it was not prescribed. Do not give RYDAPT to other people, even if they have the same condition or symptoms you have. It may harm them. You can ask your pharmacist or health care provider for information about RYDAPT that is written for health care professionals.