"Since 2003, Multidata has been under a consent decree of permanent injunction that prohibits the company from designing, manufacturing, processing, and distributing medical devices, among other restrictions, according to the FDA.
In U.S. phase 1 trials, single doses of up to 345 mg/m² of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg/m² of irinotecan have been given in non-U.S. trials. The adverse events in these patients were similar to those reported with the recommended dosage and regimen. There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhea. There is no known antidote for overdosage of CAMPTOSAR. Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.
CAMPTOSAR Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/8/2016
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