The following section is provided to help you better evaluate the efficacy, safety, and benefits of ZUPLENZ® (ondansetron). For further details about ZUPLENZ, please see the complete Prescribing Information.
|What are the indications for ZUPLENZ?|
|What is the active ingredient in ZUPLENZ?|
|How is ZUPLENZ different from other antiemetics?|
|How does ZUPLENZ compare to ondansetron orally disintegrating tablets?|
|What is the recommended dosing for ZUPLENZ?|
|What are the most common side effects of ZUPLENZ?|
What are the indications for ZUPLENZ?
ZUPLENZ is indicated for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
What is the active ingredient in ZUPLENZ?
The active ingredient in ZUPLENZ is ondansetron, which has been shown to be effective in the prevention
of nausea and vomiting. ZUPLENZ is available in 4-mg and 8-mg doses.
How is ZUPLENZ different from other antiemetics?
ZUPLENZ is the first and only 5-HT3 receptor antagonist available in an oral soluble film that prevents nausea and vomiting. ZUPLENZ films dissolve rapidly in the mouth in about 10 seconds and can be taken with or without water. Each peppermint-flavored film is individually packaged for discreet, on-the-go use.
How does ZUPLENZ compare to ondansetron orally disintegrating tablets?
In 3 clinical studies, under varying conditions, ZUPLENZ was found to be comparable to ondansetron orally disintegrating tablets.
ZUPLENZ delivers the trusted efficacy of ondansetron in a quick-dissolving film. ZUPLENZ dissolves rapidly in the mouth in about 10 seconds and can be taken with or without water.
What is the recommended dosing for ZUPLENZ?
ZUPLENZ is available in 4-mg and 8-mg films, the same strength of oral ondansetron, with the same recommended dosing. Dosing varies according to indication. Please refer to the complete Prescribing Information for ZUPLENZ.
What are the most common side effects of ZUPLENZ?
The most common side effects of ZUPLENZ are headache, tiredness and body discomfort, constipation, and diarrhea.
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.