Three Types of Systemic Mastocytosis Treatment | RYDAPT® (midostaurin) capsules

INDICATION for RYDAPT^® (midostaurin) capsules

RYDAPT is an oral prescription medicine used to treat adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

It is unknown if RYDAPT is safe and 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 aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) included:

nausea
vomiting
diarrhea
swelling of the hands, feet, or ankles
muscle or bone pain
stomach-area pain
tiredness
upper respiratory infection
constipation
fever
headache
trouble breathing

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

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.

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

Please see the full Prescribing Information and the FDA-approved Patient Information for RYDAPT^® (midostaurin) capsules.

< Back To Site

Prescribing Info
including Patient Info

Patient Support Line
1-800-282-7630,
9 am - 8 pm ET

INDICATION for RYDAPT^® (midostaurin) capsules

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 sw...

INDICATION for RYDAPT^® (midostaurin) capsules

It is unknown if RYDAPT is safe and 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

nausea
vomiting
diarrhea
swelling of the hands, feet, or ankles
muscle or bone pain
stomach-area pain
tiredness
upper respiratory infection
constipation
fever
headache
trouble breathing

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

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.

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

Please see the full Prescribing Information and the FDA-approved Patient Information for RYDAPT^® (midostaurin) capsules.

Back To Site

RYDAPT^® (midostaurin) capsules is an oral prescription medicine used to treat adults with advanced systemic mastocytosis (SM). RYDAPT is the only FDA-approved treatment for advanced SM, including those patients with a certain mutation known as the KIT D816V mutation.

How does RYDAPT work?

RYDAPT is thought to work by slowing or stopping the growth of abnormal mast cells in the body. RYDAPT is also thought to block the release of the histamines that may be causing some of the symptoms of advanced SM.

How do I know if RYDAPT is right for me?

RYDAPT is only for patients diagnosed with advanced SM, which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Talk to your doctor to see if RYDAPT is right for you.

How to Take Treatment

Find out more about how to take RYDAPT capsules.

Download the RYDAPT NOW Patient Support Brochure

View the support offerings for eligible patients taking RYDAPT (PDF).

Financial Resources

Learn about financial support while on treatment.

Next: How Treatment May Help

Understanding Treatment

RYDAPT

How does RYDAPT work?

How do I know if RYDAPT is right for me?