"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
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: 8/22/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/19/2008
Additional Aloxi Capsules Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.