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In clinical studies, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m2 to patients with various cancers. The adverse reactions in these patients were similar to those reported with the recommended dose and regimen.
There have been reports of overdose with non-liposomal irinotecan at doses up to approximately twice the recommended therapeutic dose of irinotecan, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhoea.
There is no known antidote for overdose of ONIVYDE pegylated liposomal. Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.
