CAL STUDIES, above, 62 percent were 65 years and older and 21 percent were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition there were no relevant differences in the frequency of adverse events observed in patients 65 years and older compared to younger patients.
Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION section).
ADVERSE REACTIONS
Overview
Adverse Reactions Described in Other Labeling Sections: neutropenia, thrombocytopenia, elevated serum creatinine, renal failure, renal tubular acidosis, hypokalemia, hepatic coma.
Most Commonly Occurring Adverse Reactions (SC Route): nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, fatigue, injection site erythema, constipation, neutropenia, ecchymosis.
Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC Route):
Discontinuation: leukopenia (5.0%), thrombocytopenia (3.6%), neutropenia (2.7%).
Dose Held: leukopenia (4.5%), neutropenia (4.5%), febrile neutropenia (2.7%).
Dose Reduced: leukopenia (4.5%), neutropenia (4.1%), thrombocytopenia (3.2%).
Discussion of Adverse Reactions Information
The data described below reflect exposure to Vidaza in 268 patients, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). Vidaza was studied primarily in supportive care-controlled and uncontrolled trials (n= 150 and n=118, respectively). The population in the subcutaneous studies (n = 220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML. The population in the IV study (n = 48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m2.
The following table presents the most common adverse events, whether or not considered drug related by investigators, occurring in at least 5% of patients treated with Vidaza in the supportive care-controlled trial and the uncontrolled subcutaneous trial combined. It is important to note that duration of exposure was longer for the Vidaza-treated group than for the observation group: patients received Vidaza for a mean of 11.4 months while mean time in the observation arm was 6.1 months.
Table 4: Most Frequently Observed Adverse Events (≥5% in All Vidaza)*
|
Preferred Term** |
All Vidaza‡
(N=220) |
Observation†
(N=92) |
|
At least 1 TEAE |
219 (99.5) |
89 (96.7) |
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