Xinmei Decitabine for Injection

1. Indications and Usage
Myelodysplastic Syndromes (MDS): Treatment of previously untreated, intermediate-1, high-risk, or secondary MDS.
Acute Myeloid Leukemia (AML): Treatment of patients with AML who are ineligible for intensive induction chemotherapy.
2. Dosage and Administration
Standard Regimen: Typically administered intravenously over 1 hour at a dose of 20 mg/m² daily for 5 consecutive days per cycle.
Cycle Duration: Cycles are usually repeated every 4 to 6 weeks. Dose adjustments may be necessary based on toxicity and recovery of bone marrow function.
Administration: Administered via intravenous infusion only. It must not be administered intramuscularly or subcutaneously due to the risk of severe local tissue injury.
3. Mechanism of Action
DNA Methyltransferase Inhibition: Decitabine is a hypomethylating agent that inhibits DNA methyltransferase.
Epigenetic Modulation: It incorporates into DNA and traps the enzyme, leading to hypomethylation of DNA. This results in the reactivation of silenced tumor suppressor genes and inhibition of leukemia cell growth.
4. Safety and Warnings
Severe Myelosuppression: The most common adverse reaction is bone marrow suppression, including severe neutropenia, thrombocytopenia, and anemia.
Tumor Lysis Syndrome: May occur rapidly following the first dose, especially in patients with a high leukemic cell burden.
Pregnancy and Fetal Toxicity: Can cause fetal harm if administered to a pregnant woman.
Infection Risk: Increased risk of fatal infections due to neutropenia and immunosuppression.
5. Adverse Reactions and Clinical Research
Common: Neutropenia, thrombocytopenia, anemia, fatigue, nausea, vomiting, diarrhea, and peripheral edema.
Serious: Febrile neutropenia, septic shock, tumor lysis syndrome, and drug-induced hypersensitivity reactions.
Clinical Research: Clinical trials have demonstrated significant improvement in complete remission rates and overall survival in high-risk MDS and AML patients.
6. Drug Interactions
Live Vaccines: Concomitant use with live vaccines (e.g., intranasal influenza vaccine) is contraindicated due to the risk of vaccine infection.
Hepatotoxic or Nephrotoxic Drugs: Caution is advised when co-administering drugs that may exacerbate bone marrow suppression or organ toxicity.
7. Pharmaceutical Information
Active Ingredient: Decitabine.
Appearance: White to off-white lyophilized powder or cake.
Storage: Store at room temperature. Reconstituted solutions should be used immediately or stored under specified conditions.