Rydapt is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Rydapt is used together with other cancer medicines to treat acute myeloid leukemia.

Rydapt is also used to treat certain rare blood disorders, including systemic mastocytosis with mast cell leukemia or other cancers affecting the blood, bone marrow, or lymphatic tissue.

Both men and women using Rydapt should use effective birth control to prevent pregnancy. Midostaurin can harm an unborn baby if the mother or father is using this medicine.

Take Rydapt exactly as prescribed by your doctor. Your doctor will perform a test to make sure Rydapt is the right treatment for your condition.

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

Rydapt is usually taken 2 times per day (once every 12 hours) with food.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

You may be given medication to prevent nausea or vomiting while you are taking this medicine.

If you vomit shortly after taking Rydapt, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not crush or open a Rydapt capsule.

You may need frequent blood tests (every 1 to 4 weeks). Rydapt is usually given until your body no longer responds to the medication.

Use all medications as directed by your doctor. Read the instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store the capsules in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Acute Myeloid Leukemia:

50 mg orally twice a day at approximately 12 hour intervals on Days 8 to 21 of each cycle of induction AND on Days 8 to 21 of each cycle of consolidation.

Comments:
-This drug is not indicated as a single-agent induction therapy for acute myeloid leukemia (AML) patients.
-Information on FDA-approved tests for the detection of FLT3 mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

Use: In combination with standard cytarabine and daunorubicin induction and high-dose cytarabine consolidation, treatment of newly diagnosed AML who are FLT3 mutation-positive as detected by a FDA approved test.

Usual Adult Dose for Systemic Mastocytosis:

100 mg orally twice a day at approximately 12 hour intervals
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Monitor for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Uses: Treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Usual Adult Dose for Leukemia:

100 mg orally twice a day at approximately 12 hour intervals
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Monitor for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Uses: Treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

You should not use Rydapt if you are allergic to midostaurin.

Tell your doctor if you have ever had:

• lung disease or breathing problems.

You may need to have a negative pregnancy test before starting this treatment.

Midostaurin can harm an unborn baby or cause birth defects if the mother or the father is using Rydapt.

• If you are a woman, do not use midostaurin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of midostaurin on the baby.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Rydapt.

Rydapt may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because midostaurin can harm an unborn baby.

You should not breastfeed while using Rydapt and for at least 4 months after your last dose.

Rydapt is not approved for use by anyone younger than 18 years old.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Rydapt: hives, warmth, redness, or tingly feeling; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or sores in or around your mouth, redness inside your mouth, sore throat;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• signs of infection around where a needle was injected to give you other medicines - bruising, swelling, warmth, redness, oozing, or bleeding around the needle;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common Rydapt side effects may include:

• low blood cell counts, fever;

• bruising, nosebleeds;

• high blood sugar;

• infection around a needle injection;

• mouth sores;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• trouble breathing;

• nausea, vomiting, stomach pain, constipation, diarrhea;

• muscle or bone pain;

• headache, feeling tired; or

• swelling in your hands, feet, or ankles.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with midostaurin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.