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Decitabine for injection
DACOGEN™
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FDA Approval: |
May 2006 |
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Indication: |
Myelodysplastic syndromes |
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Pharmacology: |
antineoplastic; 2-deoxycytidine analog |
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Usual Dose: |
15 mg/m2 by IV infusion over 3 hours, every 8 hours for 3
days; repeat cycle every 6 weeks
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Contraindications: |
Hypersensitivity to decitabine
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Warnings: |
May cause fetal harm; pregnancy should be avoided during treatment;
males should not father a child during treatment and for 2 months
after discontinuation Causes neutropenia and thrombocytopenia; CBC
and platelets should be monitored
Dosage should be adjusted based on hematologic response
Caution is recommended in renal and liver insufficiency
Baseline liver function tests and serum creatinine should be
measured
Safety and efficacy not established in pediatric patients
Lactation: Breastfeeding should be discontinued or the drug
should be discontinued
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Pregnancy Category: |
D |
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Side Effects: |
Most common: Neutropenia, thrombocytopenia, anemia, fatigue,
pyrexia, nausea, cough, petechiae, constipation, diarrhea,
hyperglycemia
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Drug Interactions: |
none known |
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