Midostaurin
Acute Myeloid Leukemia, Systemic Mastocytosis ... show more
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
NO
Midostaurin
Summary
Midostaurin is used to treat acute myeloid leukemia with FLT3 mutations and certain types of systemic mastocytosis, including aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia.
Midostaurin is a kinase inhibitor. It blocks the action of abnormal proteins that signal cancer cells to multiply. By inhibiting these proteins, it helps stop the spread of cancer and mast cells.
For adults with acute myeloid leukemia, the recommended dose of Midostaurin is 50 mg orally twice daily with food on specific days of the chemotherapy cycle. For systemic mastocytosis, the dose is 100 mg orally twice daily with food.
Common side effects of Midostaurin include nausea, vomiting, diarrhea, headache, and fatigue. Serious adverse effects can include pulmonary toxicity, severe neutropenia, and embryofetal toxicity.
Midostaurin may cause fetal harm and is not recommended during pregnancy. It's also advised not to breastfeed while taking Midostaurin and for 4 months after the last dose. It may interact with strong CYP3A inhibitors and inducers, and St. Johns wort, which can affect its effectiveness.
Indications and Purpose
How does Midostaurin work?
Midostaurin is a kinase inhibitor that blocks the action of abnormal proteins signaling cancer cells to multiply. By inhibiting these proteins, it helps stop the spread of cancer and mast cells, making it effective in treating acute myeloid leukemia and systemic mastocytosis.
Is Midostaurin effective?
Midostaurin has been shown to improve overall survival in patients with FLT3-mutated acute myeloid leukemia when used in combination with standard chemotherapy. It also demonstrates efficacy in treating advanced systemic mastocytosis, with a significant overall response rate. Clinical trials have established its effectiveness in these conditions, supporting its use as a treatment option.
What is Midostaurin?
Midostaurin is used to treat acute myeloid leukemia with FLT3 mutations and certain types of systemic mastocytosis. It works by inhibiting kinase proteins that signal cancer cells to multiply, helping to stop the spread of cancer and mast cells. This medication is taken orally and is often used in combination with other chemotherapy drugs.
Directions for Use
For how long do I take Midostaurin?
The duration of Midostaurin use varies depending on the condition being treated. For acute myeloid leukemia, it is used in combination with chemotherapy and may continue as maintenance therapy for up to 12 cycles of 28 days each. For systemic mastocytosis, treatment continues as long as there is clinical benefit or until unacceptable toxicity occurs. Always follow your doctor's guidance on treatment duration.
How do I take Midostaurin?
Take Midostaurin orally with food, twice daily at approximately 12-hour intervals. Do not open or crush the capsules. Avoid grapefruit and grapefruit juice, as they can interact with the medication. Always follow your doctor's instructions regarding dosage and any dietary restrictions.
How long does it take for Midostaurin to start working?
The time it takes for Midostaurin to start working can vary based on the condition being treated and individual patient factors. In clinical trials, some patients began to see effects within a few weeks, but it may take longer for others. Your doctor will monitor your progress and adjust treatment as needed.
How should I store Midostaurin?
Store Midostaurin in its original container at room temperature, away from excess heat and moisture. Keep it tightly closed and out of reach of children. Do not store it in the bathroom. For disposal, use a medicine take-back program to ensure it is not consumed by pets, children, or others.
What is the usual dose of Midostaurin?
For adults with acute myeloid leukemia (AML), the recommended dose of Midostaurin is 50 mg orally twice daily with food on specific days of the chemotherapy cycle. For systemic mastocytosis, the dose is 100 mg orally twice daily with food. Midostaurin is not recommended for use in children due to the risk of prolonged hematological recovery. Always follow your doctor's advice for dosing.
Warnings and Precautions
Can I take Midostaurin with other prescription drugs?
Midostaurin interacts with strong CYP3A inhibitors, which can increase its concentration and risk of toxicity. It also interacts with strong CYP3A inducers, which can decrease its effectiveness. Patients should avoid St. John's wort and consult their doctor about any other medications they are taking to manage potential interactions.
Can Midostaurin be taken safely while breastfeeding?
Women are advised not to breastfeed while taking Midostaurin and for 4 months after the last dose due to the potential for serious adverse reactions in breastfed infants. Consult your healthcare provider for personalized advice and alternative feeding options during treatment.
Can Midostaurin be taken safely while pregnant?
Midostaurin may cause fetal harm and is not recommended during pregnancy. Women of reproductive potential should use effective contraception during treatment and for 4 months after the last dose. A negative pregnancy test is required before starting treatment. If pregnancy occurs, contact your doctor immediately. Animal studies have shown embryo-fetal toxicities.
Is it safe to drink alcohol while taking Midostaurin?
Midostaurin contains alcohol as an excipient, and while occasional or moderate drinking is not specifically contraindicated, alcohol may exacerbate certain side effects like nausea or dizziness. It's best to consult your doctor for personalized advice regarding alcohol consumption while taking Midostaurin.
Is it safe to exercise while taking Midostaurin?
Midostaurin may cause side effects such as fatigue, dizziness, and shortness of breath, which could limit your ability to exercise. If you experience these symptoms, it's important to discuss them with your doctor. They can provide guidance on safe levels of physical activity while taking this medication.
Is Midostaurin safe for the elderly?
For elderly patients, Midostaurin should be used cautiously, especially in those eligible for intensive chemotherapy. There is no specific dose adjustment required based on age, but the greater frequency of concomitant diseases or other drug therapies in older adults should be considered. Always consult a healthcare provider for personalized advice.
Who should avoid taking Midostaurin?
Important warnings for Midostaurin include the risk of embryo-fetal toxicity, pulmonary toxicity, and potential interactions with other drugs. It is contraindicated in patients with hypersensitivity to Midostaurin or its excipients. Patients should be monitored for pulmonary symptoms and avoid use during pregnancy and breastfeeding. Always consult a healthcare provider for personalized advice.