Pronunciation: MYE doe STAW rin

Brand: Rydapt

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

Use birth control to prevent pregnancy, whether you are a man or a woman. Midostaurin use by either parent may cause birth defects. Avoid pregnancy and breast-feeding for at least 4 months after you stop using this medicine.

What is midostaurin?

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

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 be used only if your tumor has a specific genetic marker, for which your doctor will test.

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

What should I discuss with my healthcare provider before taking midostaurin?

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

To make sure midostaurin is safe for you, tell your doctor if you have ever had:

  • lung disease or breathing problems.

Midostaurin can harm an unborn baby or cause birth defects, whether the mother or father is taking this medicine.

  • If you are a woman, do not use midostaurin if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. 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 a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is using midostaurin. 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 taking midostaurin.

You should not breast-feed while using this medicine and for at least 4 months after your last dose.

How should I take midostaurin?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Midostaurin 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 midostaurin.

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

Do not crush or open a midostaurin capsule.

While using midostaurin, 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.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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?

Get emergency medical help if you have signs of an allergic reaction: 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;
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • low blood cell counts --fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.

Common side effects may include:

  • fever, flu-like symptoms;
  • mouth sores;
  • unusual bleeding or bruising;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • trouble breathing;
  • nausea, vomiting, stomach pain, constipation, diarrhea;
  • muscle or joint pain;
  • headache, feeling tired; or
  • swelling.

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 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.

Where can I get more information?

Your pharmacist can provide more information about midostaurin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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