Etoposide Teva Warnings

Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur; therefore, patients being treated with etoposide must be frequently observed for myelosuppression both during and after therapy. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Therefore, the following laboratory studies should be obtained at the start of therapy and prior to each subsequent dose of etoposide: platelet count, hemoglobin and differential white blood cell count. The occurrence of a platelet count below 50,000/mm³ or an absolute neutrophil count below 500/mm³ is an indication to withhold further therapy until blood counts have sufficiently recovered. Etoposide should be given only by slow intravenous infusion (usually over a 30- to 60-minute period), since hypotension has been reported as a possible side effect of rapid intravenous injection. Anaphylaxis manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension may occur (see Adverse Reactions). Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of presser agents, corticosteroids, antihistamines or volume expanders, at the discretion of the physician.
Mutagenicity: The mutagenic and genotoxic potential of etoposide have been established in mammalian cells. Etoposide caused aberrations in chromosome number and structure in embryonic murine cells and human hematopoietic cells; gene mutations in Chinese hamster ovary cells and DNA damage by strand breakage and DNA-protein cross-links in mouse leukemia cells.
Carcinogenicity: Carcinogenicity tests with etoposide have not been conducted in laboratory animals. Etoposide should be considered a potential carcinogen in humans.
Teratogenicity: Etoposide is teratogenic and embryotoxic in rats and mice at doses of 1% to 3% of the recommended clinical dose based on body surface area.