DRUG INTERACTIONS
No studies of interactions with other drugs have been conducted in humans.
Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. No metabolic-based drug interactions are therefore anticipated with these agents in patients.
In preclinical in vivo studies, rasburicase did not affect the activity of isoenzymes CYP1A, CYP2A, CYP2B, CYP2C, CYP2E, and CYP3A, suggesting no induction nor inhibition potential. Clinically relevant P450-mediated drug-drug interactions are therefore not anticipated in patients treated with the recommended ELITEK dose and dosing schedule.
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OVERDOSAGE
No cases of overdosage with ELITEK have been reported. The maximum dose of ELITEK that has been administered as a single dose is 0.20 mg/kg; the maximum daily dose that has been administered is 0.40 mg/kg/day. According to the mechanism of action of ELITEK, an overdose will lead to low or undetectable plasma uric acid concentration, which has no known clinical consequences. Patients suspected of receiving an overdose should be monitored, and general supportive measures should be initiated as no specific antidote for ELITEK has been identified.
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CONTRAINDICATIONS
ELITEK is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) (see BOX WARNINGS, Hemolysis and WARNINGS, Hemolysis).
ELITEK is contraindicated in patients with a known history of anaphylaxis or hypersensitivity reactions, hemolytic reactions or methemoglobinemia reactions to ELITEK or any of the excipients (see BOX WARNINGS and WARNINGS).
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