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Dacogen Generic Name & Formulations
Legal Class
Rx
General Description
Decitabine 50mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Nucleoside analogue.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
YES
Dacogen Indications
Indications
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.
Dacogen Dosage and Administration
Adult
May premedicate with antiemetics. 3-day regimen: give by continuous IV infusion over 3hrs. 15mg/m2 every 8hrs for 3 days, repeat every 6 weeks. 5-day regimen: give by continuous IV infusion over 1hr. 20mg/m2 once daily for 5 days, repeat every 4 weeks. Both regimens: give 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.
Children
Not established.
Dacogen Contraindications
Not Applicable
Dacogen Boxed Warnings
Not Applicable
Dacogen Warnings/Precautions
Warnings/Precautions
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. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Dacogen Pharmacokinetics
See Literature
Dacogen Interactions
Not Applicable
Dacogen Adverse Reactions
Adverse Reactions
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).
Dacogen Clinical Trials
See Literature
Dacogen Note
Not Applicable
Dacogen Patient Counseling
See Literature
