INDICATION for RYDAPT® (midostaurin) capsules
RYDAPT is an oral prescription medicine used in combination with certain chemotherapy medicines to treat adults with newly diagnosed acute myeloid leukemia (AML) who have a defect in a gene called FLT3. Your doctor will perform a test to make sure RYDAPT is right for you. RYDAPT should not be used alone to induce remission in people with AML.
RYDAPT is not safe when given to children in combination with chemotherapy. It is not known if RYDAPT is effective in children.
IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules
Allergic Reactions
- Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT
- If you develop signs of an allergic reaction, seek medical help immediately
- Signs of an allergic reaction include trouble breathing, flushing, chest pain, throat tightness, and swelling of the face, lips, tongue, or throat
Pregnancy, Breastfeeding, Fertility
- RYDAPT should not be used during pregnancy since it may harm an unborn baby
- If you become pregnant, think you may be, or are planning to be, tell your doctor right away
- If you are able to become pregnant, your doctor should perform a pregnancy test within 7 days before you start RYDAPT. Effective birth control should be used during treatment and for at least 4 months after the last RYDAPT dose
- Men taking RYDAPT who have female partners who are able to become pregnant should use effective birth control during treatment with RYDAPT and for at least 4 months after the last dose
- Pregnancy registry: There is a pregnancy registry that monitors the health of females and their babies exposed to RYDAPT during pregnancy. Females who have taken RYDAPT during pregnancy, or who have been exposed to RYDAPT during pregnancy through a male partner taking RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or at https://psi.novartis.com
- Do not breastfeed during treatment with RYDAPT and for at least 4 months after the final dose
- RYDAPT may impair fertility in males and females. You should discuss this with your doctor before starting treatment
Lung Problems
- RYDAPT may cause serious lung problems that may lead to death when used alone or in combination with other chemotherapy medicines
- If you develop a new or worsening cough, shortness of breath, or chest discomfort, contact your doctor immediately. These may be signs of serious lung problems
Side Effects
Most common side effects reported during RYDAPT treatment for acute myeloid leukemia (AML) included:
- low level of white blood cells with fever (febrile neutropenia)
- nausea
- redness, pain, or ulcers inside the mouth (mucositis)
- vomiting
- headache
- bruising
- muscle or bone pain
- nose bleeds
- device-related infection
- high blood sugar levels (hyperglycemia)
- upper respiratory infection
- abnormal electrocardiogram (QT prolongation)
- If side effects including nausea, vomiting, and diarrhea occur, get worse, or do not go away during treatment with RYDAPT, you should contact your doctor immediately. Your doctor may need to decrease your dose, temporarily stop, or completely stop your treatment with RYDAPT
- These are not all of the possible side effects of RYDAPT. For more information, ask your doctor or pharmacist
Taking Other Medicines With RYDAPT
- Before taking RYDAPT, you should tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYDAPT may affect how these medicines work, or these other medicines may affect how RYDAPT works
- You should also tell your doctor if you are already taking RYDAPT and are prescribed a new medicine that you have not taken previously during RYDAPT treatment
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.
Please see the full Prescribing Information and the FDA-approved Patient Information for RYDAPT® (midostaurin) capsules.
