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FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting
Date:8/23/2008

al and repeat courses of moderately emetogenic chemotherapy. One ALOXI 0.5 mg capsule is administered approximately one hour prior to the start of chemotherapy.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. There were no adverse reactions that occurred greater than or equal to 5 percent for the 0.5 mg oral dose. The most commonly reported adverse reactions were headache (3.7 percent) and constipation (0.6 percent).

Please see the ALOXI prescribing information, available at http://www.ALOXI.com, for important additional details.

About ALOXI Injection

ALOXI (palonosetron HCl) injection 0.25 mg is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist to be indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. ALOXI injection 0.075 mg is also approved as a single intravenous dose administered immediately before the induction of anesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence greater than or equal to 2 percent) in ALOXI CINV trials were headache (9 percent) and constipation (5 percent), and in PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent).

Please see the ALOXI prescribing information, available at http://www.ALOXI.com, for important additional details.

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