PANCREAZE product and medical information
If you have any questions about PANCREAZE, please contact VIVUS Medical Information at the number below.
MEDICAL INFORMATION
Phone: 1 (888) 998-4887
If you have any questions about PANCREAZE, please contact VIVUS Medical Information at the number below.
MEDICAL INFORMATION
Phone: 1 (888) 998-4887
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*Managed Markets Insight & Technology, LLC, database as of October 2022. Certain plans may require prior authorization.
Indication
PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food.
Important Safety Information
What is the most important information I should know about PANCREAZE?
PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.
Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.
Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.
What should I tell my doctor before taking PANCREAZE?
Tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What are the possible side effects of PANCREAZE?
PANCREAZE may cause serious side effects, including:
The most common side effects include pain in your stomach (abdominal pain) and gas.
These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to VIVUS LLC at 1-888-998-4887.
How do I take PANCREAZE?
Please read the PANCREAZE Medication Guide and PANCREAZE Product Information and discuss any questions you have with your doctor.
References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS LLC; 2021. 2. CREON® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2022. 3. PERTZYE® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2020. 4. ULTRESA® Full Prescribing Information. Bridgewater, NJ: Aptalis Pharma US, Inc; 2014. 5. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 6. ZENPEP® Full Prescribing Information. Bridgewater, NJ: Nestlé HealthCare Nutrition, Inc; 2020. 7. Pezilli R, et al. Exocrine pancreatic insufficiency in adults: A shared position statement of the Italian association for the study of the pancreas. World J Gastroenterol 2013;19 (44):7930-7946. 8. Lindkvist B. Diagnosis and treatment of pancreatic exocrine insufficiency. World J Gastroenterol. 2013;19(42):7258-7266. 9. The Cystic Fibrosis Foundation (n.d.). About Cystic Fibrosis. Retrieved from https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/ 10. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):29. 11. Othman MO, et al. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. .2018;72:e13066. 12. The National Pancreas Foundation (n.d.). About Chronic Pancreatitis. Retrieved from https://pancreasfoundation.org/patient-information/chronic-pancreatitis/ 13. Trapnell BC, et al. Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2011;10(5):350-356 14. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved from https://www.cff.org/phthalates 15. Fousekis FS, Theopistos VI, Katsanos KH, Christodoulou DK. Pancreatic Involvement in Inflammatory Bowel Disease: A Review. J Clin Med Res. 2018;10(10):743-751. doi:10.14740/jocmr3561w. 16. Cleveland Clinic. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://my.clevelandclinic.org/health/diseases/21577-exocrine-pancreatic-insufficiency-epi 17. Everyday Health. January 2, 2020. 5 Symptoms of Exocrine Pancreatic Insufficiency. Retrieved from https://www.everydayhealth.com/hs/exocrine-pancreatic-insufficiency/know-the-symptoms-of-epi/ 18. Loma Linda University Health. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://lluh.org/conditions/exocrine-pancreatic- insufficiency-epi
Important Safety Information
PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.
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