"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).
Prevention of Chemotherapy-Induced Nausea and Vomiting
ALOXI (palonosetron hcl capsules) Capsules are indicated for:
- Moderately emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses
DOSAGE AND ADMINISTRATION
Dosage for Adults - one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. ALOXI (palonosetron hcl capsules) can be taken with or without food.
Dosage Forms And Strengths
Capsules, 0.5 mg
NDC #62856-799-05, ALOXI (palonosetron hcl capsules) Capsules, 0.5 mg (free base), are supplied as light beige opaque soft gelatin capsules, five capsules per bottle, each bottle packaged in a small carton.
- Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
- Protect from light.
Jointly manufactured by: Catalent Pharma Solutions, Somerset NJ and Philadelphia PA, USA, and Helsinn Birex Pharmaceuticals, Dublin, Ireland. HELSINN, Manufactured for Helsinn Healthcare SA, Switzerland. Distributed and marketed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised 08/2008. FDA Rev date: 8/22/2008
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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