Monograph Details
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Neoplasms
> Antimetabolites
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VIDAZA |
| Manufacturer |
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Celgene Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Cytidine analogue. |
| Generic Name |
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Azacitidine 100mg/vial; pwd for SC inj after reconstitution or IV inj after reconstitution and dilution; contains mannitol; preservative-free. |
| Indications |
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Myelodysplastic syndromes (refractory anemias, chronic myelomonocytic leukemia). |
| Children |
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Not recommended. |
| Adults |
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Premedicate for nausea & vomiting. Initially 75mg/m2 SC (doses >4mL divide equally into 2 syringes and inject into 2 separate sites) or IV (infuse over 10–40 minutes, must complete within 1 hour of reconstitution) daily for 7 days; repeat cycle every 4 weeks. May increase to 100mg/m2 after 2 cycles if no response and no toxicity. Treat for at least 4–6 cycles. Adjust subsequent doses on blood counts and toxicities (eg, neutropenia, thrombocytopenia, decreased serum bicarbonate). |
| Contraindications |
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Advanced malignant hepatic tumors. |
| Precautions |
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Renal or hepatic impairment. High tumor burden. Obtain CBC counts before each dosing cycle and as needed. Monitor serum bicarbonate and renal and hepatic function (do baseline liver chemistries and serum creatinine). Elderly. Pregnancy (Cat.D); use appropriate contraception (both men and women). Nursing mothers: not recommended. |
| Adverse Reactions |
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GI upset, blood dyscrasias (esp. anemia, thrombocytopenia, neutropenia, leukopenia), fever, fatigue, inj site reactions, constipation, ecchymosis, petechiae, rigors, dyspnea, arthralgia, headache, anorexia, renal failure/tubular acidosis, hypokalemia, hepatic coma, others (see literature). |
| How Supplied |
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Single-use vial—1 |
| Additional Resources |
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• Related Prescribing Note |
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