HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VIDAZA safely and effectively. See full prescribing information for VIDAZA.
VIDAZA (azacitidine for injection) for SC or IV use
Initial U.S. Approval: 2004
INDICATIONS AND USAGE
VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is VIDAZA 75 mg/m2 daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Premedicate for nausea and vomiting. (2.1)
Repeat cycles every 4weeks (2.2). After 2 cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred (2.2). Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles (2.2).
Continue treatment as long as the patient continues to benefit (2.2).
Patients should be monitored for hematologic response and renal toxicities, with dosage delay or reduction as appropriate (2.3, 2.4, 2.5).
DOSAGE FORMS AND STRENGTHS
Lyophilized powder in 100 mg single-use vials (3).
CONTRAINDICATIONS
Advanced malignant hepatic tumors (4.1).
Hypersensitivity to azacitidine or mannitol (4.2).
WARNINGS AND PRECAUTIONS
Anemia, neutropenia and thrombocytopenia. Perform complete blood counts (CBC) prior to each treatment cycle and as needed to monitor response and toxicity. (5.1).
Hepatotoxicity: Use with caution in patients with severe preexisting liver impairment (5.2).
Renal abnormalities. Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys (5.3).
Monitor liver chemistries and serum creatinine prior to initiation of therapy and with each cycle (5.4).
VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to a fetus. (5.5, 8.1).
Men should be advised not to father a child while receiving VIDAZA (5.6, 13).
ADVERSE REACTIONS
Most common adverse reactions (>30%) by SC route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
No formal assessments of drug-drug interactions between VIDAZA and other agents have been conducted (7).
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother (8.3).
Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function (8.5).