Prevention of Chemotherapy-Induced Nausea and Vomiting

ALOXI (palonosetron hydrochloride) is indicated for:

• Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
• Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses

Recommended Dosing

Dosage for Adults - a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy

Instructions for Administration

ALOXI (palonosetron hydrochloride) is supplied ready for intravenous injection. ALOXI (palonosetron hydrochloride) should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of ALOXI (palonosetron hydrochloride) .

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

Dosage Form And Strengths

ALOXI (palonosetron hydrochloride) is supplied as a single-use sterile, clear, colorless solution in glass vials that provides 0.25 mg (free base) per 5 mL.

HOW SUPPLIED/STORAGE AND HANDLING

NDC # 58063-797-25, 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton

Storage

• Store at controlled temperature of 20-25°C (68°F-77°F). Excursions permitted to 15-30 °C (59-86°F).
• Protect from freezing.
• Protect from light.

Mfd by: Cardinal Health, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals, Dublin, Ireland
HELSINN, Mfd for Helsinn Healthcare SA, Switzerland
MGI PHARMA, INC. Distributed and marketed by MGI PHARMA, INC. Bloomington, MN. 55437 under license of Helsinn Healthcare SA, Switzerland. FDA rev date: 8/30/2007

Last reviewed on RxList: 9/27/2007
This monograph has been modified to include the generic and brand name in many instances.