For patients with CINV, RINV, or PONV*

ZUPLENZ IS Designed for a smoother treatment journey

Trusted ondansetron efficacy in a thin, minty film strip that dissolves in seconds1,2

A unique pill alternative with bioequivalence to ondansetron orally disintegrating tablet (ODT).1,2
  —Proven, nonsedating efficacy under fed and fasting conditions1,2
ZUPLENZ dissolves in seconds with or without water.1,2
  —Maximum concentration of ondansetron is seen between 1.3 and 1.7 hours post dose1,2

  • 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

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

How ZUPLENZ can help

ZUPLENZ provides a MINTY, non-gritty alternative TO HELP PREVENT NAUSEA
AND VOMITING

  • Much like a breath-freshening strip, flexible 100-micron ZUPLENZ strip is not gritty or chalky
  • ZUPLENZ film dissolves on the tongue within 4 to 20 seconds1

Discreet, "on-the-go" administration accommodates treatment schedules

Individually wrapped strips are portable and can go almost anywhere patients go.
ZUPLENZ may be taken with or without water or food.1,2
ZUPLENZ is for use before or after treatment per dosing guidelines.1

  • 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

References

  1. ZUPLENZ (package insert). Midatech Pharma US Inc. 2016.
  2. Dadey E. Bioequivalence of ondansetron oral soluble film 8 mg (ZUPLENZ) and ondansetron orally disintegrating tablets 8 mg (ZOFRAN) in healthy adults. Am J Ther. 2015;22(2):90-97.
  3. National Institutes of Health, National Cancer Institute. Treatment-related nausea and vomiting (PDQ®)–health professional version. https://www.cancer.gov/about-cancer/treatment/side-effects/nausea/nausea-hp-pdq#section/_11. Updated May 10, 2017. Accessed July 19, 2017.
  4. Nevidjon B, Chaudhary R. Controlling emesis: evolving challenges, novel strategies. J Support On col. 2010;8(4 suppl 2):1-10.
  5. Tageja N, Groninger H. Chemotherapy-induced nausea and vomiting: an overview and comparison of three consensus guidelines. Postgrad Med J. 2016;92(1083):34-40.
  6. American Cancer Society. Nutrition for the person with cancer during treatment: a guide for patients and families. https://contentlib.mckessonspecialtyhealth.com/resources/Nutrition%20Family%20Guide.pdf. Updated June 9, 2014. Accessed July 20, 2017.

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 Fortovia 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 Fortovia at 1-855-273-0468 for medical inquiries.

Please see full Prescribing Information.