1 INDICATIONS AND USAGE
1.1 Myelodysplastic Syndromes (MDS)
2 DOSAGE AND ADMINISTRATION
2.1 First Treatment Cycle
2.2 Subsequent Treatment Cycles
2.3 Dosage Adjustment Based on Hematology Laboratory Values
2.4 Dosage Adjustment Based on Renal Function and Serum Electrolytes
2.5 Use in Geriatric Patients
2.6 Preparation of VIDAZA
2.7 Instructions for Subcutaneous Administration
2.8 Instructions for Intravenous Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Advanced Malignant Hepatic Tumors
4.2 Hypersensitivity to Azacitidine or Mannitol
5 WARNINGS AND PRECAUTIONS
5.1 Anemia, Neutropenia and Thrombocytopenia
5.2 Severe Preexisting Hepatic Impairment
5.3 Renal Abnormalities
5.4 Monitoring Laboratory Tests
5.5 Pregnancy
5.6 Use in Males
6 ADVERSE REACTIONS
6.1 Overview
6.2 Adverse Reactions in Clinical Trials
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Gender
8.7 Race
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Myelodysplastic Syndromes (MDS)
VIDAZA® is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (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).

2 DOSAGE AND ADMINISTRATION
2.1 First Treatment Cycle
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7days. Patients should be premedicated for nausea and vomiting.

2.2 Subsequent Treatment Cycles
Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.

Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions (5.3)], and dosage delay or reduction as described below may be necessary.

2.3 Dosage Adjustment Based on Hematology Laboratory Values
For patients with baseline (start of treatment) WBC ≥3.0 x109/L, ANC ≥