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Important Safety Information Full Prescribing Information


ALOXI® vs. Dolasetron in Moderately Emetogenic Chemotherapy

Significantly higher CR rates in delayed CINV vs dolasetron

  • Complete Response was the primary endpoint of this noninferiority trial1,2
  • The most common types of cancer for patients in this trial were breast, lung, and non-Hodgkin’s lymphoma (≥5% of patients in any group)3
  • The most common chemotherapy regimens for patients in this trial were cyclophosphamide, doxorubicin, epirubicin, and carboplatin (≥10% of patients in any
    group)2

Complete Response1,2†

(No emetic episode and no use of rescue medication)

Complete Response

* Double-blind, randomized, Phase III noninferiority trial comparing single doses of ALOXI with dolasetron following MEC with a primary endpoint of CR. p≤0.025 (adjusted post-hoc, 2-sided, Fisher's exact test comparisions of ALOXI with dolasetron; 97.5% CI).
† ITT cohort.

  • ALOXI was demonstrated to be noninferior to dolasetron in the acute phase1,2
    • Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase1
  • A single IV dose of ALOXI provided significantly higher response rates vs dolasetron in the delayed phase (p=0.004)1,2

Indication

In adults, ALOXI® (palonosetron HCl) injection 0.25 mg is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Important Safety Information

  • Aloxi is contraindicated in patients known to have hypersensitivity to the drug of any of its components
  • Most commonly reported adverse reactions in chemotherapy-induced nausea and vomiting include headache (9%) and constipation (5%)

For more information about ALOXI, please see Full Prescribing Information

References
  1. ALOXI® (palonosetron HCl) injection full prescribing information.
  2. Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98:2473-2482.
  3. Data on file. Eisai Inc., Woodcliff Lake, NJ.
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ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.
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