There have been five ELOXATIN overdoses reported. One patient received two 130 mg/m² doses of ELOXATIN (cumulative dose of 260 mg/m²) within a 24-hour period. The patient experienced Grade 4 thrombocytopenia ( < 25,000/mm³) without any bleeding, which resolved. Two other patients were mistakenly administered ELOXATIN instead of carboplatin. One patient received a total ELOXATIN dose of 500 mg and the other received 650 mg. The first patient experienced dyspnea, wheezing, paresthesia, profuse vomiting and chest pain on the day of administration. She developed respiratory failure and severe bradycardia, and subsequently did not respond to resuscitation efforts. The other patient also experienced dyspnea, wheezing, paresthesia, and vomiting. Her symptoms resolved with supportive care. Another patient who was mistakenly administered a 700 mg dose experienced rapid onset of dysesthesia. Inpatient supportive care was given, including hydration, electrolyte support, and platelet transfusion. Recovery occurred 15 days after the overdose. The last patient received an overdose of oxaliplatin at 360 mg instead of 120 mg over a 1-hour infusion by mistake. At the end of the infusion, the patient experienced 2 episodes of vomiting, laryngospasm, and paresthesia. The patient fully recovered fromthe laryngospasmwithin half an hour. At the time of reporting, 1 hour after onset of the event, the patient was recovering fromparesthesia.

There is no known antidote for ELOXATIN overdose. In addition to thrombocytopenia, the anticipated complications of an ELOXATIN overdose include myelosuppression, nausea and vomiting, diarrhea, and neurotoxicity. Patients suspected of receiving an overdose should be monitored, and supportive treatment should be administered.

ELOXATIN should not be administered to patients with a history of known allergy to ELOXATIN or other platinumcompounds [see WARNINGS and PRECAUTIONS].

Bookmark this page: