MIDOSTAURIN

Background and Date of Approval

Midostaurin is an anticancer medication that was approved for medical use in April 2017.

Uses

Midostaurin is a prescription medicine developed to treat acute myeloid leukemia caused by a mutation in FLT3 genes. It is also indicated to treat aggressive system mast cytosis, systemic mast cytosis with hematological neoplasm, and mast cell leukemia.

How is it administered?

Midostaurin is available in form of Capsules in the dose 25mg. The usual recommended dosing is 50mg twice daily with food for acute myeloid leukemia and 100mg twice daily for aggressive systemic mast cytosis and systemic mast cytosis. Swallow Midostaurin Capsule whole with a glass of water.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Midostaurin Capsule are nausea, vomiting, diarrhoea, tiredness, constipation, nose bleeds, muscle or bone pain, upper respiratory tract infection, bruising, mouth ulcers, headache, fever, trouble breathing, high blood sugar levels, stomach pain, swelling of hands and feet. If you experience any allergic reactions or any other symptoms like shortness of breath, chills, or swelling, report to your doctor immediately.

Warnings

Midostaurin not recommended for patients who are allergic to Midostaurin, or its ingredients. It is essential to let your physician know if you are diagnosed with problems in your kidneys or liver. Your physician will regularly monitor your blood cell count, blood pressure, cholesterol, liver and kidney parameters to prevent complications. Seek immediate medical attention if you experience worsening cough, chest discomfort or shortness of breath.

Precautions

Midostaurin can affect the fertility of male and female patients. Female patients and female partners of male patients should avoid getting pregnant during this treatment. Tell your healthcare provider if you are pregnant, think you might be pregnant, breastfeeding or planning to have a baby. Discuss effective contraceptive methods with your healthcare practitioner and continue using birth control methods for 4 months after the final dose of Midostaurin. Do not breastfeed during and 4 months after the last dose of Midostaurin capsule.

Word of Advice

Avoid driving and operating machinery while receiving Midostaurin treatment if dizziness occurs. Your doctor will prescribe medications to manage nausea and vomiting associated with Midostaurin therapy.

References

Novartis, US Food & Drug Administration, [Revised on Nov 2021] [Accessed on 25th Oct 2022], https://www.novartis.com/us-en/sites/novartis_us/files/rydapt.pdf Anton Wellstein, Giuseppe Giaccone, Michael B. Atkins, and Edward A. Sausville, Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules, Goodman & Gilman’s Pharmacological Basis of Therapeutics, 13th Edition, 2018, 1203-1236.

Frequently Asked Questions

Is Midostaurin a chemotherapy drug?

Azacytidine is a targeted anticancer drug that is classified under kinase inhibitors.

Is it safe to undergo surgery during treatment with Midostaurin?

Midostaurin might cause unusual bleeding and bruising. Hence, it is advisable to avoid planning for surgery. Discuss with your healthcare provider before you undergo any surgical or dental procedures.

Who should not take Midostaurin?

Midostaurin is not recommended for people who are allergic to Midostaurin, or its ingredients.

What should you do if you vomit after taking Midostaurin?

If you vomit after taking your dose of Midostaurin, take your next dose as per the schedule and do not take an additional dose on the same day.

How to store Midostaurin?

Store Midostaurin Capsules at 20-25°C in its original container and keep them away from children.

How do you manage side effects of Midostaurin Capsule?

Reach out to your healthcare provider if you experience any unusual symptoms after taking Midostaurin Capsule. Your healthcare provider might recommend to decrease the dose or stop Midostaurin therapy temporarily or permanently based on the severity of side effects.

What tests do you need to undergo before starting treatment with Midostaurin?

Before and during treatment with Midostaurin, your healthcare provider will conduct pregnancy test and blood tests to decide whether Midostaurin is correct for you.

What is MrMed’s Patient Assistance Program?

MrMed’s Patient Assistance Program (PAP) enables patients to access sufficient information on how to purchase cancer medications at minimum cost. Contact MrMed’s helpline desk to check your eligibility.

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Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS