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  4. Data on File. CSR04795/08-09. Portland, OR; Galena Biopharma, Inc.
  5. ZOFRAN Prescribing Information. GlaxoSmithKline. 2006.
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    double-blind, randomized comparison of oral ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with highly emetogenic chemotherapy. Support Care Cancer. 1999;7:347-353.
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  8. Priestman TJ, Roberts JT, Upadhyaya BK. A prospective randomized double-blind trial comparing ondansetron versus prochlorperazine for the prevention of nausea and vomiting in patients undergoing fractionated radiotherapy. Clin Oncol. 1993;5:358-363.
  9. Rust M, Cohen LA. Single oral dose ondansetron in the prevention of postoperative nausea and emesis. Anaesthesia. 1994;49(suppl):16-23.
  10. Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006;24(18):2932-2947.
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  17. Roila F, Hesketh PJ, Herrstedt J. The Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC). Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol. 2006;17:20-28.
  18. The Italian Group for Antiemetic Research in Radiotherapy. Radiation-induced emesis: a prospective observational multicenter Italian trial. Int J Radiat Oncol Biol Phys. 1999;44(3):619-625.
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For the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

ZUPLENZ (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron.

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Avoid ZUPLENZ in patients with congenital long QT syndrome. Monitor ECG in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

The most common adverse drug events (≥5%) in chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting were: headache, malaise/fatigue, constipation, and diarrhea. The most common adverse event (≥5%) in postoperative nausea and vomiting was headache.

ZUPLENZ is available by prescription only. Please click here for complete Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.

For more information about ZUPLENZ, call 1-855-636-5710.