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Rydapt is the brand name for midostaurin and is available as an oral capsule.

Rydapt is available as a 25 mg oral capsule.

Rydapt 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

Rydapt 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. Rydapt works by blocking several kinases in blood cancer (leukemia) cells, which then prevents these cells from growing. Rydapt works specifically on leukemia cells that have the FLT3 mutation. For systemic mastocytosis and mast cell leukemia, Rydapt 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.

Rydapt 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 Rydapt

Rydapt 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 Rydapt:

• 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 Rydapt. 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 Rydapt:

• 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 Rydapt

Novartis Pharmaceuticals

Rydapt may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Rydapt or think you may be pregnant.
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 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 Report Novartis 
If you are able to become pregnant, your healthcare provider may perform a pregnancy test within 7 days before you start Rydapt. Females who are able to become pregnant should use effective birth control (contraception) during treatmentwith Rydapt and for 4 months after the last dose of Rydapt. Males who have female partners that are able to become pregnant should use effective birth control during
treatment with Rydapt and for 4 months after the last dose of Rydapt.

• Midostaurin