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Indication
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ALOXI® injection is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
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Important Safety Information
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CONTRAINDICATIONS
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ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components |
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Please see below for additional Important Safety Information.
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Why ALOXI?
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For over 13 years, ALOXI has offered some of your appropriate patients 5 days of CINV prevention following moderately emetogenic chemotherapy in a single, ready-to-use dose.1,2
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The only FDA-approved IV 5-HT3 RA indicated to prevent acute and delayed CINV in adult patients1*† |
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For additional assistance or clinical resources, please contact your ALOXI sales representative or visit ALOXI.com.
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If you have any questions about the information in this email, contact Eisai Medical Information at 1-888-274-2378, 8:30 AM to 5 PM ET, Monday through Friday.
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In adults receiving moderately emetogenic chemotherapy (MEC).
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Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI (n=189) with ondansetron (n=185) with a primary endpoint of complete response during the acute phase (Day 1) following MEC. ALOXI demonstrated significantly greater complete response in the acute phase (81.0% vs 68.6%, p=0.0085) and in the delayed phase (74.1% vs 55.1%, p<0.001). Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase.1,2
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Important Safety Information (continued)
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WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists |
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Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue ALOXI and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs |
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ADVERSE REACTIONS
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In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%) |
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For more information about ALOXI, please see Full Prescribing Information.
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References: 1. ALOXI® (palonosetron HCl) injection. Full Prescribing Information. 2. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577.
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