Generic Name: ondansetron
Dosage Form: film, soluble
Indications and Usage for Zuplenz
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
Zuplenz (ondansetron) oral soluble film is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m 2[see Clinical Studies (14.1)]
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
Zuplenz is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy [see Clinical Studies (14.1)].
Prevention of Nausea and Vomiting Associated With Radiotherapy
Zuplenz is indicated for the prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen [see Clinical Studies (14.2)].
Prevention of Postoperative Nausea and/or Vomiting
Zuplenz is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Zuplenz is recommended even where the incidence of postoperative nausea and/or vomiting is low [see Clinical Studies (14.3)].
Zuplenz Dosage and Administration
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
Adults
The recommended adult oral dosage of Zuplenz (ondansetron) oral soluble film is 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m 2. Each Zuplenz oral soluble film should be allowed to dissolve completely before administering the next film. [see Dosage and Administration (2.6)]. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatrics
Safety and effectiveness of Zuplenz in pediatric patients have not been established for this indication.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
Adults
The recommended adult oral dosage is one 8 mg Zuplenz oral soluble film given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg Zuplenz oral soluble film should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].
Pediatrics
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg Zuplenz oral soluble film given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg Zuplenz oral soluble film should be administered three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].
Prevention of Nausea and Vomiting Associated With Radiotherapy
Adults
The recommended adult oral dosage of Zuplenz oral soluble film is one 8 mg film given three times a day