Chinese instructions for Midostaurin

1. Indications:

Midostaurin (Midostaurin) is a multi-target tyrosine kinase inhibitor used to treat the following diseases:

1.Acute myeloid leukemia (AML): Midostaurin is used in newly diagnosed adult AML patients, in which FLT3gene mutation is FLT3-ITD or FLT3-TKD.

2.Kinase-positive systemic mast cell disease (SM-AHN): Midostaurin is used in SM-AHN patients, specifically adult patients with KIT gene D816V mutation.

3.Ascending myeloid tumors: For the treatment of ascending myeloid tumors that meet specific patient populations.

2. Mechanism of action:

Midostaurin inhibits multiple kinase targets, includingFLT3, KIT, PDGFRα pan>, PDGFRβ, VGEFR, etc., thereby inhibiting cell proliferation and promoting cell apoptosis. This mechanism of action makes it effective in the treatment of hematological tumors such as AML and SM-AHN.

3. Pharmacology:

Midostaurin is rapidly absorbed by oral administration, and C_max (maximum concentration) is usually between 2 and 4Arrived within hours. It is mainly metabolized by CYP3A4 to produce a variety of metabolites. Midostaurin and its metabolites are mainly excreted through the liver, with unmetabolized midostaurin accounting for approximately 30% of the total excretion.

4. Dosage and usage:

The following is the generally recommended dosage of midostaurin, but please strictly follow the doctor's prescription and guidance:

1.Acute myeloid leukemia (AML): Adult patients take 50mg orally daily for 4 weeks in combination with standard chemotherapy regimens.

2.Kase-positive systemic mastocytosis (SM-AHN): Adult patients take 100mg orally daily for 4 weeks as monotherapy.

3.Myeloid tumors: The specific dosage should be determined according to the patient’s condition and doctor’s recommendations.

5. Side effects:

Midostaurin may cause a series of side effects, including but not limited to: nausea, vomiting, diarrhea, skin itching, rash, headache, fatigue Low platelet count, low white blood cell count, abnormal liver function, arrhythmia, pneumonia, bleeding.

6. Warnings and precautions:

Patients need to pay attention to the following when using midostaurin:

1.Liver function monitoring: Patients should check their liver function regularly during treatment, because midostaurin may cause abnormal liver function.

2.Electrocardiogram monitoring: Monitor the electrocardiogram to detect potential arrhythmias.

3.Pregnant and lactating women: Midostaurin may be harmful to the fetus and should be used after consulting a doctor. Breastfeeding women should stop breastfeeding or stop treatment.

4.Drug Interactions: Midostaurin may interact with other drugs, and patients need to inform their doctor of all medications they are taking, including over-the-counter drugs and supplements.

7. Contraindications:

Midostaurin is contraindicated in the following circumstances:

1.Patients who are allergic to midostaurin or its components.

2.Pregnant women, especially in early pregnancy.

3.Lactating women, especially in the early stages of lactation.

8. Drug interactions:

Midostaurin may interact with other medications, including but not limited to:

1.StrongCYP3A4inhibitors: May increase midostaurin concentration, need to monitor for side effects.

2.CYP3A4Inducers: may reduce the efficacy of midostaurin, requiring dose adjustment.

3.Anticoagulants: may increase the risk of bleeding, and coagulation indicators need to be closely monitored.

4.Other anti-cancer drugs: Caution is required when used in combination with other drugs for the treatment of AML or SM-AHN.

9. Medicine for special groups:

Specific patient groups, such as patients with impaired liver function, patients with impaired renal function, elderly patients, etc., may need to adjust the dose when using midostaurin, and doctors should evaluate and make recommendations based on individual circumstances.

10. Launch and price status:

Currently, Midostaurin is not available in China, so patients cannot purchase it domestically. Midostaurin abroad is divided into original drugs and generic drugs. The cheaper original version is the Indian version, which costs more than 10,000 yuan. Others include Turkish and European original drugs, which cost tens of thousands to hundreds of thousands, which are relatively expensive. Generic drugs are mainly Indian generic drugs, which cost about several thousand yuan per box. They are much cheaper than the original drug, and the drug ingredients are basically the same as the original drug.