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Midostaurin is available as a 25 mg oral capsule.

Midostaurin is a tyrosine kinase inhibitor and is used for the following:

• Acute myeloid leukemia (AML) with a specific mutation (FLT3-positive)
• Mast cell leukemia and systemic mastocytosis

Midostaurin is a type of targeted therapy called a tyrosine kinase inhibitor. Kinases are enzymes (proteins) that send signals to cells, including cancer cells, that tells them to grow. Midostaurin works by blocking several kinases in blood cancer (leukemia) cells, which then prevents these cells from growing. Midostaurin works specifically on leukemia cells that have the FLT3 mutation. For systemic mastocytosis and mast cell leukemia, Midostaurin is thought to work by slowing or stopping the growth of abnormal mast cells. It might also block the release of histamines that cause symptoms of systemic mastocytosis.

Midostaurin is dosed as follows:

• AML: The typical dosing is 50 mg by mouth twice daily on Day 8 through 21 of each treatment cycle
• Mast cell leukemia and systemic mastocytosis: The typical dosing is 100 mg by mouth twice daily
• Your provider might adjust your dose if you experience certain side effects or if you’re taking medications that might interact with Midostaurin

Midostaurin is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Midostaurin:

• Nausea
• Fever from low white blood cell counts
• High blood sugar levels
• Lower blood calcium levels
• Vomiting
• Redness, pain, or ulcers on the inside of the mouth
• Abnormal blood cell counts
• Diarrhea
• Headache
• Swelling in the hands and feet
• Abnormal liver labs
• Higher pancreatic enzyme levels
• Higher uric acid levels
• Red/brown/purple spots on skin

Serious side effects are rare with Midostaurin. Contact your healthcare provider immediately if you experience any of the following.

• Lung problems: cough, trouble breathing, chest pain

The following medications may interact with Midostaurin:

• Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase exposure to Midostaurin and its active metabolites. Consider alternative therapies that do not strongly inhibit CYP3A4 or monitor for increased risk of adverse reactions
• Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to Midostaurin and its active metabolites. (7.1)
• CYP2B6, BCRP, OATP1B1 Substrates: Dose adjustments for coadministered CYP2B6, BCRP, and OATP1B1 substrates may be necessary with Midostaurin

Various FDA-approved generic manufacturers

Midostaurin may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Midostaurin or think you may be pregnant.
Pregnancy Registry: There is a pregnancy registry that monitors the health of females and their babies exposed
to Midostaurin during pregnancy. Females who have taken Midostaurin during pregnancy or have been exposed to
Midostaurin during pregnancy through a male partner taking Midostaurin should contact Novartis Pharmaceuticals
Corporation at 1-888-669-6682, or at Report Novartis 
If you are able to become pregnant, your healthcare provider may perform a pregnancy test within 7 days before you start Midostaurin. Females who are able to become pregnant should use effective birth control (contraception) during treatmentwith Midostaurin and for 4 months after the last dose of Midostaurin. Males who have female partners that are able to become pregnant should use effective birth control during
treatment with Midostaurin and for 4 months after the last dose of Midostaurin.

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