Monograph Details
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Neoplasms
> Antimetabolites
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DACOGEN |
| Manufacturer |
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MGI Pharma, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue. |
| Generic Name |
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Decitabine 50mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution. |
| Indications |
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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. |
| Children |
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Not recommended. |
| Adults |
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Give by continuous IV infusion over 3 hours. May premedicate with anti-emetics. First cycle: 15mg/m2 every 8 hours for 3 days. Subsequent cycles: repeat every 6 weeks for a minimum of 4 cycles; continue until disease progression. Dose adjustment based on hematology values: see literature. Non-hematologic toxicities (eg, serum creatinine ≥2mg/dL; SGPT, total bilirubin ≥ 2 X ULN; active or uncontrolled infection): do not restart until toxicity resolved. |
| Precautions |
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Renal or hepatic impairment. Obtain CBC counts before each dosing cycle and as needed. Monitor hepatic function (do baseline liver chemistries and serum creatinine). Pregnancy (Cat.D); use appropriate contraception (both men and women). Nursing mothers: not recommended. |
| Adverse Reactions |
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Neutropenia, thrombocytopenia, anemia, leukopenia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, hyperglycemia. |
| How Supplied |
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Single-use vial—1 |
| Additional Resources |
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• Related Prescribing Note |
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