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CINV, chemotherapy-induced nausea and vomiting; RINV, radiation-induced nausea and vomiting; PONV, postoperative nausea and vomiting.

Reference

  1. ZUPLENZ (package insert). Midatech Pharma US Inc. 2016.

IMPORTANT SAFETY INFORMATION

  • ZUPLENZ is contraindicated in patients who are concomitantly using apomorphine. Concomitant use of ZUPLENZ and apomorphine may result in profound hypotension and loss of consciousness.
  • ZUPLENZ is contraindicated in patients with a known hypersensitivity to ondansetron as anaphylactic reactions have been known to occur.
  • ZUPLENZ may mask a progressive ileus and/or gastric distention in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting.
  • Patients with severe hepatic impairment (Child-Pugh score of 10 or greater) should not receive more than 8mg of ZUPLENZ per day due to a reduction in drug clearance.
  • Patients receiving ondansetron have experienced ECG changes including QT interval prolongation, including cases of Torsade de Pointes. ZUPLENZ should be used with caution in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medications that can lead to QT interval prolongation. ZUPLENZ should not be used in patients with congenital long QT syndrome.
  • Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Discontinue using ZUPLENZ at the first sign of hypersensitivity.
  • Serotonin syndrome has been reported in patients taking 5-HT3 receptor agonists, with most cases being reported in patients taking serotonergic drugs concomitantly with ondansetron. Some of these cases were fatal. Some reported cases of serotonin syndrome occurred in patients who have overdosed on ondansetron alone.
  • ZUPLENZ is Pregnancy Category B and should only be used during pregnancy for the approved indications if clearly needed.
  • The most common adverse events occurring in clinical trials of ondansetron in CINV and RINV patients included: headache, malaise/fatigue, constipation and diarrhea. The most common adverse events occurring in a clinical trial of ondansetron in PONV included: headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus. In the PONV study, only headache was statistically more significant than adverse events seen in placebo patients.
  • ZUPLENZ has been shown to be safe and effective for use in pediatric patients 4 years of age and older who are undergoing moderately emetogenic cancer chemotherapy. It has not been proven safe and effective in any other pediatric indication.

You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, or call Midatech at 1-855-273-0468 for medical inquiries.

Please see full Prescribing Information.

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IMPORTANT SAFETY INFORMATION

  • ZUPLENZ is contraindicated in patients who are concomitantly using apomorphine. Concomitant use of ZUPLENZ and apomorphine may result in profound hypotension and loss of consciousness.
  • ZUPLENZ is contraindicated in patients with a known hypersensitivity to ondansetron as anaphylactic reactions have been known to occur.
  • ZUPLENZ may mask a progressive ileus and/or gastric distention in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting.
  • Patients with severe hepatic impairment (Child-Pugh score of 10 or greater) should not receive more than 8mg of ZUPLENZ per day due to a reduction in drug clearance.
  • Patients receiving ondansetron have experienced ECG changes including QT interval prolongation, including cases of Torsade de Pointes. ZUPLENZ should be used with caution in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medications that can lead to QT interval prolongation. ZUPLENZ should not be used in patients with congenital long QT syndrome.
  • Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Discontinue using ZUPLENZ at the first sign of hypersensitivity.
  • Serotonin syndrome has been reported in patients taking 5-HT3 receptor agonists, with most cases being reported in patients taking serotonergic drugs concomitantly with ondansetron. Some of these cases were fatal. Some reported cases of serotonin syndrome occurred in patients who have overdosed on ondansetron alone.
  • ZUPLENZ is Pregnancy Category B and should only be used during pregnancy for the approved indications if clearly needed.
  • The most common adverse events occurring in clinical trials of ondansetron in CINV and RINV patients included: headache, malaise/fatigue, constipation and diarrhea. The most common adverse events occurring in a clinical trial of ondansetron in PONV included: headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus. In the PONV study, only headache was statistically more significant than adverse events seen in placebo patients.
  • ZUPLENZ has been shown to be safe and effective for use in pediatric patients 4 years of age and older who are undergoing moderately emetogenic cancer chemotherapy. It has not been proven safe and effective in any other pediatric indication.

You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, or call Midatech at 1-855-273-0468 for medical inquiries.

Please see full Prescribing Information.