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What is PANCREAZE?

PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes.

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. Fibrosing colonopathy has been reported with high dosages of pancreatic enzyme products, usually with use over a prolonged period of time and in pediatric patients with cystic fibrosis. Colonic stricture has been reported in pediatric patients less than 12 years of age.

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:

• are allergic to pork (pig) products
• have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy)
• have gout, kidney disease, or high blood uric acid (hyperuricemia)
• have trouble swallowing capsules
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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:

• A rare bowel disorder called fibrosing colonopathy
• Irritation of the inside of your mouth. This can happen if PANCREAZE is not swallowed completely
• Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels. This may occur if you have gout or renal impairment. Contact your healthcare provider if you experience pain, stiffness, redness or swelling of your joints.
• Allergic reactions including trouble with breathing, skin rashes, or swollen lips
• PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

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?

• Take PANCREAZE with meals or snacks.
• Swallow capsules whole.
• For adult and pediatric patients unable to swallow intact capsules, the capsule contents may be sprinkled on a small amount of acidic food with a pH of 4.5 or less (e.g., applesauce).
• For pediatric patients birth to 12 months of age, PANCREAZE capsules can also be opened, and the capsule contents sprinkled directly into the infant’s mouth.
• Consume sufficient liquids (juice, water, breast milk, or formula) and visually inspect an infant’s mouth to ensure complete swallowing of PANCREAZE capsules or capsule contents.
• Do not crush or chew PANCREAZE capsules or capsule contents.

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; 2024. 2. CREON^® Full Prescribing Information. Chicago, IL: AbbVie, Inc; 2024. 3. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2024. 4. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 5. ZENPEP^® Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2024. 6. 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. 7. Cleveland Clinic. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://my.clevelandclinic.org/health/diseases/21577-exocrine-pancreatic-insufficiency-epi 8. Othman MO, et al. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72:e13066. 9. Cleveland Clinic. (n.d.). Pancreas. Retrieved from https://my.clevelandclinic.org/health/body/21743-pancreas 10. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):29. 11. Lindkvist B. Diagnosis and treatment of pancreatic exocrine insufficiency. World J Gastroenterol. 2013;19(42):7258-7266. 12. The National Pancreas Foundation (n.d.). About Chronic Pancreatitis. Retrieved from https://pancreasfoundation.org/patient-information/chronic-pancreatitis/ 13. The Cystic Fibrosis Foundation (n.d.). About Cystic Fibrosis. Retrieved from https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/ 14. 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. 15. Mayo Clinic. (n.d.). Biliopancreatic diversion with duodenal switch (BPD/DS). Retrieved from https://www.mayoclinic.org/tests-procedures/biliopancreatic-diversion-with-duodenal-switch/about/pac-20385180 16. Mayo Clinic. (n.d.). Gastric bypass (Roux-en-Y). Retrieved from https://www.mayoclinic.org/tests-procedures/gastric-bypass-surgery/about/pac-20385189 17. Uribarri-Gonzalez L, et al. Exocrine pancreatic function and dynamic of digestion after restrictive and malabsorptive bariatric surgery: a prospective, cross-sectional, and comparative study. Surg Obes Relat Dis. 2021 Oct;17(10):1766-1772 18. Vujasinovic M, et al. Pancreatic Exocrine Insufficiency after Bariatric Surgery. Nutrients. 2017 Nov 13;9(11):1241. 19. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved March 3, 2022, from https://www.cff.org/phthalates