Midostaurin Chinese detailed instructions and medication guide

1. Common name and product name

Common name: Midostaurin (Midostaurin)

Product name:RYDAPT

2. Indications

Midostaurin is indicated for two main indications.

First, for acute myeloid leukemia (AML), it is approved for use in combination with cytarabine and daunorubicin, which are FDA-approved treatment regimens for adult patients who are positive for FLT3 mutations.

Second, midostaurin is also suitable for adult patients with systemic mastocytosis (SM), especially aggressive systemic mastocytosis (ASM), systemic mastocytosis with hematological tumors (SM-AHN), and mast cell leukemia (MCL).

3. Usage and dosage

Patient selection was based onthe presence of FLT3 mutation positivity. The recommended dose is 50 mg twice daily for AML patients, taken orally with food on days 8-21 of induction therapy with cytarabine and daunorubicin and on days 8-21 of consolidation therapy with high-dose cytarabine. For patients with ASM, SM-AHN and MCL, the recommended dose is 100 mg twice daily, taken orally with food. Prophylactic antiemetics should be given before drug use to reduce the risk of nausea and vomiting, and patients must be closely monitored for toxic effects.

4. Adverse reactions

In clinical studies of midostaurin,Common adverse reactions in AML patients include fever, neutropenia, nausea, vomiting and other symptoms. Nausea, vomiting, diarrhea, etc. are also common adverse reactions in patients with ASM, SM-AHN and MCL. Physicians should monitor patients regularly while taking midostaurin.

5. Supply and storage

MidostaurinSupplied as 25 mg soft gel capsules, should be stored at 20°C to 25°C, away from moisture. Storage needs to be kept in the original container to ensure the stability of the drug.

6. Taboo

This drug should be contraindicated in patients who are allergic to midostaurin or its components. Allergic reactions may manifest as difficulty breathing, facial flushing, etc. Patients should be questioned in detail before use.

7. Mechanism of action

Midostaurin, as a small molecule inhibitor, mainly works by inhibiting the activity of multiple receptor tyrosine kinases. It can effectively inhibit the signaling of FLT3, KIT, PDGFR and other receptors, thereby inhibiting cell proliferation and inducing apoptosis. This allows midostaurin to show good results in the treatment of related leukemias.

8. Special groups

While using midostaurin, female patients need to take a pregnancy test before treatment and take effective contraceptive measures during treatment and within 4 months after stopping treatment Male patients should also take contraceptive measures during treatment and within 4 months after stopping the drug to avoid the potential impact of the drug on fertility. Because midostaurin may have serious adverse reactions in breastfed infants, women are advised not to breastfeed during treatment and for 4 months after stopping the drug.

Reference materials:https://go.drugbank.com/drugs/DB06595