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![HELP YOUR PATIENTS WEATHER CHEMOTHERAPY BETTER[1]](http://email.hs-digital.com/email/ALX-65498/RNSights/images/help_your.jpg)
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![LEARN MORE ABOUT ALOXI: 5 DAYS STRONG[2]](http://email.hs-digital.com/email/ALX-65498/RNSights/images/header_learn.jpg)
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Moderately emetogenic chemotherapy (MEC). Anthracycline-cyclophosphamide (AC).
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In a trial versus ondansetron in adults receiving 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).2
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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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Continuous power in a single dose
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Significantly greater complete response rates compared to ondansetron2‡
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Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI with ondansetron with a primary endpoint of complete response during the acute phase (Day 1) following MEC. P values represent adjusted post hoc, 2-sided Fisher's exact test comparison of ALOXI with ondansetron. Significance level=0.025, 97.5% CI.2 |
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In adults receiving MEC. |
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Intent-to-treat (ITT) cohort. |
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52.4% of patients received AC-based chemotherapies, which were considered MEC at the time of the study3,4 |
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A single IV dose of ALOXI provided significantly higher complete response rates vs ondansetron in both the acute and delayed phases (p=0.0085 and p<0.001)2 |
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Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase1 |
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Significantly fewer patients who received ALOXI experienced nausea (secondary endpoint) on Days 2-4 following MEC than those who received ondansetron4|| |
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Pairwise testing revealed differences between the treatment groups on Day 2 (p=0.003), Day 3 (p=0.003), and Day 4 (p=0.009). There was no difference between treatment groups on Days 1 and 5 (p=NS).4
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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. 3. Hesketh PJ. Defining the emetogenicity of cancer chemotherapy regimens: relevance to clinical practice. The Oncologist. 1999;4:191-196. 4. Data on file. Eisai, Inc.
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