ALOXI® Phase III Clinical Trials

BETTER IN ACUTE, BETTER IN DELAYED,
BETTER OVERALL

  • Better Overall CINV Prevention* 1-3
      - Acute: ALOXI® 72.0% vs. ondansetron/dolasetron 60.6%
      - Delayed: ALOXI 64% vs. ondansetron/dolasetron 46.8%
  • Only 5-HT3 receptor antagonist indicated for the prevention of delayed CINV associated with moderately emetogenic chemotherapy.4-7
  • Highest receptor binding affinity† and longest half-life (~40 hrs) in the class.4-7,8,9
  • A single, 0.25 mg fixed IV dose administered over 30 seconds, 30 minutes prior to chemotherapy.4

Click here to review the results of ALOXI Phase III clinical trials.

* Pooled CR rates (no emesis, no rescue medications) from two identically designed phase III clinical trials involving moderately emetogenic chemoterapy: 97.5% CI and two-sided Fisher’s exact test (significance level=0.025) indicate a difference between ALOXI and ondansetron/dolasetron.

In vitro; clinical significance has not been established.

References
  1. 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.
  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. Rubenstein EB, Gralla RJ, Eisenberg P, et al. Palonosetron (PALO) compared with Ondansetron (OND) or dolasetron (DOL) for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV): combined results of two phase II trials. Proc Am Soc Clin Oncol. 2003;22:729.
  4. ALOXI® (palonosetron HCl) injection full prescribing information.
  5. Anzemet® (dolasetron mesylate) full prescribing information.
  6. Zofran® (ondansetron hydrochloride) full prescribing information.
  7. Kytril® (granisetron hydrochloride) full prescribing information.
  8. Wong EHF, Clark R, Leung E, et al. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol. 1995;114:851-859.

During initial and repeat courses of chemotherapy, ALOXI helps prevent and control nausea and vomiting the day following chemotherapy that is highly likely to cause nausea and vomiting, and for up to 5 days following chemotherapy that is likely to cause nausea and vomiting. The most frequent side effects of ALOXI include headache and constipation. If you have or may develop significant heart rhythm changes, talk with your healthcare professional before receiving ALOXI.

ALOXI is available by prescription only. Please see the important product information for ALOXI for more information.

This site does not contain everything that is known about ALOXI. If you would like to know more, talk to your healthcare professional.