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Rydapt (Midostaurin) Information

Rydapt, which contains the active ingredient midostaurin, is a targeted therapy medication, a multikinase inhibitor. It is primarily used to treat adults with newly diagnosed acute myeloid leukemia (AML) that has a specific genetic mutation called FLT3. In these cases, it is used in combination with standard chemotherapy. It is also used to treat certain rare blood disorders characterized by the overproduction of mast cells, such as aggressive systemic mastocytosis (ASM) and mast cell leukemia. The medication is taken by mouth as a soft capsule, typically twice daily (approximately 12 hours apart). For patients with AML, Rydapt is usually taken on specific days during the chemotherapy cycle. For mast cell disorders, it is often taken continuously. It is important to take Rydapt with food to help prevent stomach upset and ensure proper absorption. For AML, 50 mg twice daily (on specific days of the chemo cycle) and for Mast Cell Disorders, 100 mg twice daily (taken continuously).

The mechanism of action of midostaurin involves blocking several kinases, including FLT3 and KIT. In certain leukemias and mast cell disorders, these proteins are mutated or overactive, sending constant signals that tell diseased cells to grow and divide. By inhibiting these signals, Rydapt helps kill cancer cells or prevent them from multiplying, helping move the disease into remission.

Rydapt Side Effects

Rydapt is generally well-tolerated, but common side effects may occur as your body adjusts to the medication. Commonly reported effects include nausea, vomiting, diarrhea, headache, tiredness (fatigue), and mouth sores. You may also experience muscle or joint pain, a mild skin rash, or cold-like symptoms such as a sore throat. In AML patients, it is common to experience a drop in white blood cells. You may not feel this symptom, but your doctor will monitor it.

More serious side effects can occur and require immediate medical attention. Stop taking the medication and seek help if you experience:
• Lung problems: A new or worsening cough, chest pain, or trouble breathing (which may indicate lung inflammation).
• Severe allergic reactions: Swelling of the face, lips, or throat; hives; or significant difficulty breathing.
• Severe digestive issues: Vomiting or diarrhea that is severe and does not stop, which can lead to dehydration.
• Signs of infection: Fever, chills, or extreme weakness, which may be due to low white blood cell counts.
• Unusual bleeding: Easy bruising, nosebleeds, or blood in the stool, which may indicate a drop in platelets.

Rydapt Precautions

Do not use Rydapt if you have a known allergy to midostaurin or any of the inactive ingredients in the medication. Before starting treatment, inform your doctor of your complete medical history, especially if you have a history of lung or breathing problems or heart disease.

Tell your doctor about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements (such as St. John's wort). Rydapt has significant interactions with many drugs, especially those that affect liver enzymes, such as certain antifungals or antibiotics, which can dangerously change the level of Rydapt in your blood.

Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Rydapt can cause serious harm to a developing fetus and must not be used during pregnancy. Women of childbearing age should have a pregnancy test before starting treatment and must use effective contraception during treatment and for at least four months after the final dose. Men with female partners who can become pregnant should also use effective contraception during treatment and for four months after the final dose. Breastfeeding is not recommended while taking Rydapt and for at least four months after the last dose.

Take Rydapt exactly as your doctor tells you. Swallow the capsules whole with a glass of water; do not open, crush, or chew them. Taking your dose with a meal can significantly reduce nausea. If you miss a dose, skip it and take your next dose at the regular time—never take two doses at once to make up for a missed one. Store the capsules at room temperature in their original container to protect them from moisture and light, and keep them safely out of reach of children.

Do I need a prescription to order Rydapt?

Yes, a prescription is required from your physician to order Rydapt.