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Myelosuppression: Bone marrow suppression is the dose limiting toxicity of etoposide therapy. Therefore, patients being treated with etoposide must be frequently observed for myelosuppression both during and after therapy. Regular monitoring of blood counts should be done at the start of therapy and prior to each subsequent course of etoposide. If the platelet count is below 50,000/mm3 or an absolute neutrophil count below 500/mm3 therapy should either be withheld or the dosage be reduced, as the case may be.
Secondary Leukemias: Secondary leukemias have occurred with long term use of etoposide.
Hypersensitivity Reactions: Etoposide can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. If hypersensitivity reactions occur, immediately interrupt etoposide and institute supportive management. Permanently discontinue etoposide in patients who experience a severe hypersensitivity reaction.
Embryo-Fetal Toxicity: Females: Based on animal studies and its mechanism of action, etoposide can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential hazard to the fetus.
Advise females of reproductive potential to use effective contraception during treatment with etoposide and for at least 6 months after the final dose.
Males: Etoposide may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during treatment with etoposide and for 4 months after the final dose.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Etoposide was embryotoxic and teratogenic in animal experiments. Etoposide was genotoxic in in vitro and in vivo tests. No conventional carcinogenicity studies have been conducted, but based on its genotoxic properties, etoposide is considered to be a potential carcinogen. In rats, an oral dose of etoposide at 86.0 mg/kg/day (about 10 times the human dose on a mg/m2 basis) or above administered for 5 consecutive days resulted in irreversible testicular atrophy. Irreversible testicular atrophy was also present in rats treated with etoposide intravenously for 30 days at 5.11 mg/kg/day (about 0.5 times the 50 mg/m2 human dose based on BSA).
Infertility: Females: In females of reproductive potential, etoposide may cause infertility and result in amenorrhea. Premature menopause can occur with etoposide. Recovery of menses and ovulation is related to age at treatment.
Males: In male patients, etoposide may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men, and in some cases, have occurred several years after the end of therapy.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Etoposide Injection contains polysorbate 80. In premature infants a life threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia and ascites has been associated with an injectable vitamin E product containing polysorbate 80.
This product contains benzyl alcohol, which has been associated with a fatal "gasping syndrome" in premature infants.
Use in the Elderly: In elderly patients taking etoposide, a small dose reduction and careful monitoring has thus been advised, even in those with normal renal and hepatic function.
