Dacogen Decitabine for Injection

1. Indications and Usage
Myelodysplastic Syndromes (MDS): Treatment of previously untreated, intermediate-1, high-risk, or secondary MDS.
2. Dosage and Administration
5-Day Regimen: 20 mg/m² intravenously over 1 hour daily for 5 consecutive days, repeated every 4 weeks.
3-Day Regimen: 15 mg/m² intravenously over 3 hours every 8 hours for 3 consecutive days, repeated every 6 weeks.
Dose Adjustments: Subsequent cycles must be delayed until hematologic recovery (Absolute Neutrophil Count ≥1,000/μL and Platelets ≥50,000/μL).
3. Mechanism of Action
DNA Methyltransferase Inhibition: Incorporates into DNA and traps the enzyme, leading to hypomethylation and reactivation of silenced tumor suppressor genes.
4. Safety and Warnings
Severe Myelosuppression: Monitor complete blood counts frequently.
Differentiation Syndrome: Monitor for signs and symptoms; initiate high-dose corticosteroids if confirmed.
Interstitial Lung Disease (ILD): Evaluate pulmonary symptoms; treat appropriately if diagnosed.
Fetal/Neonatal Toxicity: Contraception is required during and after treatment.
5. Adverse Reactions and Clinical Research
Common: Neutropenia, thrombocytopenia, anemia, fatigue, fever, nausea, vomiting, and diarrhea.
Serious: Febrile neutropenia, septic shock, tumor lysis syndrome, and drug-induced hypersensitivity.
6. Drug Interactions
Live Vaccines: Contraindicated due to immunosuppression and risk of vaccine infection.
CYP450 Interactions: Unlikely to inhibit or induce CYP450 enzymes based on in vitro studies.
7. Pharmaceutical Information
Active Ingredient: Decitabine.
Appearance: White to off-white lyophilized powder or block-like substance.
Storage: Store at or below 25°C. Reconstituted solutions should be used immediately or stored at 2-8°C for up to 7 hours.