Important Safety Information Full Prescribing Information


Powerful CINV prevention in the first 24 hours and up to 5 days following MEC

Significantly higher Complete Response (CR) rates vs ondansetron

  • 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, colon/rectal, and bladder (≥5% of patients in any group)2
  • The most common chemotherapy regimens for patients in this trial were cyclophosphamide, doxorubicin, cisplatin, and methotrexate (≥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 ondansetron following MEC with a primary endpoint of CR. p≤0.025 (adjusted post-hoc, 2-sided, Fisher’s exact test comparisons of ALOXI with ondansetron; 97.5% confidence interval [CI]).
ITT cohort

  • A single IV dose of ALOXI provided significantly higher response rates vs ondansetron in both the acute and delayed phases and during the overall study period (p=0.0085, p<0.001, and p<0.001)1,2
    • Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase1

Significantly longer time to treatment failure vs ondansetron

Kaplan-Meier plot of time to treatment failure2,3*

(First emetic episode or use of rescue medication)

Kaplan-Meier plot of time to treatment failure

* Double-blind, randomized Phase III noninferiority trial comparing single doses of ALOXI with ondansetron following MEC with a primary endpoint of CR and secondary endpoints that included time to treatment failure.
ITT cohort.

  • Time to treatment failure (secondary endpoint) was significantly longer following treatment with ALOXI than ondansetron (p<0.001)2,3
    • Median time to treatment failure was >120 hours in both treatment groups
    • Time to treatment failure in the first quartile was more than twice as long for ALOXI than ondansetron (46.5 hours vs 19.5 hours)
  • A separation in control rates appeared as early as Day 12,3

ALOXI lasts long against nausea

Nausea-free patients2,3†

Nausea-free patients

* Double-blind, randomized, Phase III noninferiority trial comparing single doses of ALOXI with ondansetron following MEC with a primary endpoint of CR and secondary endpoints that included incidence of nausea.
Patients reported nausea using a 4-point Likert scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Only patients reporting “0 = none” were considered nausea-free.
ITT cohort.

  • Significantly more patients who received ALOXI were nausea-free (secondary endpoint) on Days 2-4 following MEC than those who receive ondansetron2
  • Patients ranked nausea as one of the most distressing side effects of chemotherapy.4

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. 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. Data on file. Eisai Inc., Woodcliff Lake, NJ.
  4. de Boer-Dennert M, de Wit R, Schmitz PIM, et al. Patient perceptions of the side effects of chemotherapy: the influence of 5-HT3 antagonists. Br J Cancer. 1997;76:1055-1061.