Generic Name and Formulations:
Decitabine 50mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Otsuka America Pharmaceutical, Inc.
Indications for DACOGEN:
Myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes and Intermediate-1, Intermediate-2, and High-risk International Prognostic Scoring System groups.
May premedicate with antiemetics. 3-day regimen: give by continuous IV infusion over 3hrs. 15mg/m2 every 8hrs for 3 days. 5-day regimen: give by continuous IV infusion over 1hr. 20mg/m2 once daily for 5 days. Both: repeat every 6 weeks for a minimum of 4 cycles (based on hematologic recovery); may take longer for a complete or partial response. Dose modifications for toxicity: see full labeling.
Risk of serious and fatal myelosuppression. Obtain CBC with platelets at baseline, before each cycle, and as needed; manage appropriately if toxicity occurs. Monitor baseline hepatic function and serum creatinine. Renal or hepatic impairment; monitor. Embyro-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, hyperglycemia; non-hematologic toxicities (eg, serum creatinine ≥2mg/dL, SGPT or total bilirubin ≥2xULN, active or uncontrolled infection).