"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
There is no known antidote to ALOXI (palonosetron hcl capsules) . Overdose should be managed with supportive care.
Thirty-three adult cancer patients were administered oral palonosetron at a dose of 90 µg/kg (equivalent to 6 mg fixed dose) as part of a dose ranging study. This is approximately 12 times the recommended oral dose of 0.5 mg. This dose group had a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed.
Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single oral dose of palonosetron at 500 mg/kg in rats and 100 mg/kg in dogs (7673 and 5115 times the recommended human oral dose, respectively, based on body surface area) was lethal. The major signs of toxicity included convulsions, labored breathing, and salivation.
ALOXI (palonosetron hcl capsules) is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
Last reviewed on RxList: 9/19/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Aloxi Capsules Information
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