
ZUPLENZ is comparable to ondansetron orally disintegrating tablets
| Comparable plasma concentrations under fasting conditions2 |
An open-label, randomized, single oral dose, 2-way crossover bioavailability study comparing ZUPLENZ 8 mg to Zofran® orally disintegrating tablet 8 mg administered with water in healthy adult study participants under fasting conditions (n=48). Bioequivalence was established if the 90% confidence intervals of the ratio estimates of Cmax, AUC0-t, and AUC0-∞ were all within the 80% to 125% range for ondansetron.
| Comparable plasma concentrations under fed conditions3 |
| Comparable plasma concentrations to ondansetron orally disintegrating tablets—with or without water4 |
Cmax = maximum observed plasma concentration.
AUC0-t = area under the plasma concentration vs time curve from time zero to last measurable concentration.
AUC0-∞ = area under the plasma concentration vs time curve from time zero to infinity.
In all 3 studies, under varying conditions, patients taking ZUPLENZ had comparable plasma concentrations to ondansetron orally disintegrating tablets.2-4
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 1-866-662-7199
