Xpreza 100 Special Precautions

Anemia, Neutropenia and Thrombocytopenia: Treatment with azacitidine is associated with anemia, neutropenia and thrombocytopenia. Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response as described in posology and administration.
Severe Pre-existing Hepatic Impairment: Because azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease.
Patients with extensive tumor burden due to metastatic disease have been rarely reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline albumin <30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors. (See Contraindications.)
Safety and effectiveness of azacitidine in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials.
Renal Abnormalities: Renal abnormalities ranging from elevated serum creatinine to renal failure and death have been reported rarely in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non-MDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, the dosage should be reduced or held as described in posology and administration.
Patients with renal impairment should be closely monitored for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys. (See Dosage & Administration.)
Safety and effectiveness of azacitidine in patients with MDS and renal impairment have not been studied as these patients were excluded from the clinical trials.
Necrotising Fasciitis: Necrotising fasciitis, including fatal cases, have been reported in patients treated with azacitidine. Azacitidine for injection therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated.
Tumour lysis syndrome: The patients at risk of tumor lysis syndrome are those with high tumour burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
Information for Patients: Patients should inform their physician about any underlying liver and renal disease. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with azacitidine for injection. For nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother. Men should be advised to not father a child while receiving treatment with azacitidine.
Laboratory Tests: Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.
Drug Interactions: No formal assessments of drug-drug interactions between azacitidine and other agents have been conducted. (See Pharmacology under Actions.)
Effects on ability to drive and use machines: Azacitidine has minor or moderate influence on the ability to drive and use machines. Fatigue has been reported with the use of azacitidine. Therefore, caution is recommended when driving or operating machines.