midostaurin

What is the most important information I should know about midostaurin?

What is midostaurin?

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

Midostaurin 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.

Midostaurin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking 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.

• 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 midostaurin.

This medicine 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.

How should I take midostaurin?

Your doctor will perform a test to make sure midostaurin 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.

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 midostaurin.

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

You may need frequent blood tests (every 1 to 4 weeks). Midostaurin 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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking midostaurin?

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

What are the possible side effects of midostaurin?

• 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 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.

What other drugs will affect midostaurin?

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 affect 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.

Where can I get more information?

Your pharmacist can provide more information about midostaurin.