1. ZUPLENZ Prescribing Information. Praelia Pharmaceuticals, Inc. 2012.
  2. Data on File. CSR01905/08-09. Monosol Rx, LLC.
  3. Data on File. CSR01906/08-09. Monosol Rx, LLC.
  4. Data on File. CSR04795/08-09. Monosol Rx, LLC.
  5. ZOFRAN Prescribing Information. GlaxoSmithKline. 2006.
  6. Needles B, Miranda E, Rodriguez FMG, et al; for the S3AA3012 Study Group. A multicenter, 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.
  7. DiBenedetto J, Cubeddu LX, Ryan T, et al. Ondansetron for nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Clin Therapeutics. 1995;17(6):1091-1098.
  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.
  11. Antiemesis. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology. 2009;V.2.
  12. Antiemetic guidelines. Multinational Association of Supportive Care in Cancer (MASCC). March 2008.
  13. American Society of Health-System Pharmacists. ASHP therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health Syst Pharm. 1999;56(8):729-764.
  14. Data on File. CSR01905/08-09 (Dissolution). Monosol Rx, LLC.
  15. Data on File. CSR01906/08-09 (Dissolution). Monosol Rx, LLC.
  16. Data on File. CSR04795/08-09 (Dissolution). Monosol Rx, LLC.
  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.
  19. Enblom A, Axelsson BB, Steineck G, Hammer M, Börjeson S. One third of patients with radiotherapy-induced nausea consider their antiemetic treatment insufficient. Support Care Cancer. 2009;17(1):23-32.
  20. Apfel CC, Läärä E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91(3):693-700.
  21. Cohen MM, Duncan PG, DeBoer DP, Tweed WA. The postoperative interview: assessing risk factors for nausea and vomiting. Anesth Analg. 1994;78:7-16.
  22. Conway B. Prevention and management of postoperative nausea and vomiting in adults. AORN J. 2009;90(3):391-413.
  23. Quigley EM, Hasler WL, Parkman HP. AGA technical review on nausea and vomiting. Gastroenterology. 2001;120(1):263-286.
  24. American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002;96(3):742-752.

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 upon reports of profound hypotension and loss of consciousness.

Patients known to have hypersensitivity to ondansetron and to other selective 5-HT3 receptor antagonists should not take ZUPLENZ. Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported. Rarely and predominantly with intravenous ondansetron, transient electrocardiographic changes, including QT interval prolongation, have occurred.

The use of ZUPLENZ in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. ZUPLENZ does not stimulate gastric or intestinal peristalsis and should not be used instead of nasogastric suction.

The most common adverse drug reactions (≥5%) reported in clinical trials of patients receiving ondansetron for prevention of nausea and vomiting associated with cancer chemotherapy or radiotherapy were headache, malaise/fatigue, constipation, and diarrhea. For postoperative nausea and vomiting, headache occurred at a rate significantly different from placebo.

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 1-888-834-7800.