Anemia, neutropenia & thrombocytopenia. Patients w/ liver disease. Reports of progressive hepatic coma & death during treatment in patients w/ extensive tumor burden due to metastatic disease, especially in those w/ baseline albumin <30 g/L; renal abnormalities ranging from elevated serum creatinine to renal failure & death in patients treated w/ IV azacitidine in combination w/ other chemotherapeutic agents for
non-MDS conditions. Perform CBC as needed to monitor response & toxicity, but at min, prior to each dosing cycle; & obtain liver chemistries & serum creatinine prior to initiation of therapy. Reduce/hold dose if unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur. May experience undesirable effects eg, fatigue when driving a car or operating machines. Renal & severe pre-existing hepatic impairment. Avoid pregnancy during treatment in women of childbearing potential. Female partners of male patients receiving treatment should not become pregnant. Pregnancy & lactation.