|
|
|
|
|
Indication
|
|
|
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.
|
|
|
Important Safety Information
|
|
|
Contraindications
|
|
| • |
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components
|
|
|
|
Please see below for additional Important Safety Information.
|
|
|
Rates of nausea-free patients compared to ondansetron following MEC1
|
|
|
Nausea-free patients
|
|
|
|
| • |
Significantly more patients who received ALOXI experienced less nausea (secondary endpoint) on Days 2-4 following MEC than those who received ondansetron1
|
|
|
| • |
ALOXI helps prevent patients from developing this distressing side effect following moderately emetogenic chemotherapy2
|
|
|
| • |
Primary endpoint of this noninferiority trial was complete response (CR) in the acute phase (Day 1), ALOXI (81%) compared to ondansetron (68.6%) (p=0.0085)2
|
|
|
| |
- |
Complete response = no emetic episode and no use of rescue medication
|
|
| |
- |
Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase
|
|
|
| • |
Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI with ondansetron with a primary endpoint of CR during the acute phase 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% Cl2
|
|
|
| • |
The most common types of cancer were breast, lung, colon/rectal, and bladder (>5% of patients in any group)2
|
|
|
| • |
The most common chemotherapy regimens were cyclophosphamide, doxorubicin, cisplatin, methotrexate, and carboplatin (>10% of patients in any group)2
|
|
|
| |
- |
At the time of this study, anthracycline-cyclophosphamide (AC) was considered MEC3
|
|
|
|
|
|
CINV=chemotherapy-induced nausea and vomiting.
|
|
|
MEC=moderately emetogenic chemotherapy.
|
|
|
CI=confidence interval.
|
|
|
|
| * |
Intent-to-treat (ITT) cohort.
|
|
|
|
|
Important Safety Information (continued)
|
|
|
Warnings and Precautions
|
|
| • |
Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
|
|
|
| • |
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
|
|
|
|
Adverse Reactions
|
|
| • |
In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)
|
|
|
|
For more information about ALOXI, please see Full Prescribing Information.
|
|
|
References: 1. Data on file. Eisai Inc., Woodcliff Lake, NJ. 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. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update 2011. J Clin Oncol. 2011;29:4189-4198.
|
|
|
This is a post‑only mailing. Please do not reply to this email.
|
|
|
If you prefer not to receive further messages from this sender, please click here and confirm your request.
|
|
|
|
|
ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.
Distributed by Eisai Inc. under license of Helsinn Healthcare SA, Switzerland.
Marketed by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc.
Eisai, Inc. 100 Tice Boulevard, Woodcliff Lake, NJ 07677 - (USA).
Helsinn Therapeutics, 170 Wood Avenue South, 5th Floor, Iselin, NJ 06830 - (USA).
© 2016 Eisai Inc. All rights reserved. ALOX-US0132 06/16
|
|
|
|
|
|
