Important Safety Information Full Prescribing Information Medication Guide

PANCREAZE is indicated for the treatment of EPI (exocrine pancreatic insufficiency) in adult and pediatric patients.

PANCREAZE is available in six strengths, including a 37,000 lipase unit dose¹

PANCREAZE is available in 2,600, 4,200, 10,500, 16,800, 21,000 and 37,000 lipase unit capsules.
Prescribe PANCREAZE for both meals and snacks — make sure to specify the number of capsules that should be taken per meal and per snack.
PANCREAZE is the only approved PERT capsules that do not use phthalates as an additive.²

2,600, 4,200, 10,500, 16,800, 21,000 and 37,000 lipase unit capsules

2,600, 4,200, 10,500, 16,800, 21,000 and 37,000 lipase unit capsules

PANCREAZE should be initiated at the lowest recommended dose and gradually increased.
At lower doses, PANCREAZE has smaller increments than any other PERT available, for more individualized dosing options.^16-19
Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of ﬁbrosing colonopathy, in children with cystic ﬁbrosis less than 12 years of age.
Exercise caution when doses of PANCREAZE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
Do not substitute other pancreatic enzyme products for PANCREAZE.
Dose should be individualized based on age, weight, clinical symptoms, degree of steatorrhea and fat content of diet.

Optimizing PERT dosing when treating EPI

Effective initial dosing and titration is essential^5,20,21

Studies show that patients receiving pancreatic enzyme replacement therapy are frequently underdosed and demonstrate gaps in compliance — with many taking their enzymes solely before or after eating. This can result in complications related to fat malabsorption and malnutrition, having a negative impact on quality of life.

Clinical best practice advice^5,20

DOSING BEST PRACTICE ADVICE

PERT should be taken during the meal, with the initial treatment of at least 30,000 - 40,000 USP units of lipase during each meal in adults and one-half of that with snacks. The subsequent dosage can be adjusted based on the meal size and fat content.

WERE YOU AWARE?

A normal pancreas makes approximately 900,000 USP units of lipase during an average meal, with approximately 90,000 units of lipase needed to prevent steatorrhea.

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Dosing Calculator

An online tool to help you calculate PANCREAZE patient dosing.

Savings & Support

As of Feb 1, 2026, the PANCREAZE Savings Card now offers enhanced benefits.

SEE THE SAVINGS

*Eligible patients may pay a minimum of $0 and receive up to $2,000 off the patient’s co-pay or out-of-pocket expenses per prescription fill of PANCREAZE (pancrelipase) capsules with a maximum yearly benefit of $3,500. Out-of-pocket expenses may vary. Click here for more information.

Indication

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Important Safety Information

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

Hyperuricemia has been reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.

Irritation of the oral mucosa may occur due to loss of protective enteric coating on the capsule contents.

The presence of porcine viruses that might infect humans cannot be definitely excluded.

Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.

Please read the PANCREAZE Medication Guide and PANCREAZE Product Information.

References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS LLC; 2024. 2. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved from https://www.cff.org/phthalates. 3. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 4. Othman MO, Harb D, Barkin JA. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72:e13066. 5. Whitcomb, DC, Buchner, AM, Forsmark, CE. AGA Clinical Practice Update on the Epidemiology, Evaluation, and Management of Exocrine Pancreatic Insuﬃciency: Expert Review. Gastroenterology. 2023;165:1292–1301. 6. 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. 7. Dominguez-Muñoz JE, et al. European PEI Multidisciplinary Group. European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations. United European Gastroenterol J. 2025 Feb;13(1):125-172. 8. Radlinger B, Ramoser, G and Kaser S. Exocrine Pancreatic Insufficiency in Type 1 and Type 2 Diabetes. Current Diabetes Reports. 2020;20:18. 9. Martin TCS, Scourfield A, Rockwood N, et al. Pancreatic insufficiency in patients with HIV infection: role of didanosine questioned. HIV Medicine (2013),14,161-166. 10. Price DA, Schmid ML, Ong ELC, et al. Pancreatic exocrine insufficiency in HIV-positive patients. HIV Medicine (2005),6,33–36. 11. Vujasinovic M, Valente R, Thorell A, et al. Pancreatic Exocrine Insufficiency after Bariatric Surgery. Nutrients. 2017 Nov 13;9(11):1241. 12. Uribarri-Gonzalez L, Nieto-García L, Martis-Sueiro A, 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. 13. Struyvenberg MR, Martin CR, Freedman SD. Practical guide to exocrine pancreatic insufficiency – Breaking the myths. BMC Med. 2017; 15(1): 29. 14. Trapnell BC, Strausbaugh SD, Woo MS, 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. 15. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 16. CREON^® Full Prescribing Information. Chicago, IL: AbbVie, Inc; 2024. 17. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2024. 18. VIOKACE™ Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2024. 19. ZENPEP^® Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2025. 20. Brennan GT, Saif MW. Pancreatic Enzyme Replacement Therapy: A Concise Review. JOP. 2019;20(5):121-125. 21. Barkin JA, Harb D, Kort J, Barkin J. Real-World Patient Experience With Pancreatic Enzyme Replacement Therapy in the Treatment of Exocrine Pancreatic Insufficiency. Pancreas. 2024 Jan 1;53(1). 22. Johns Hopkins Cystic Fibrosis Center. (n.d.). Effects of CF. Retrieved from https://hopkinscf.org/knowledge/effects-of-cf/ 23. Cystic Fibrosis Foundation. Cystic Fibrosis Foundation evidence-based guidelines for management of infants with cystic fibrosis. J Pediatr. 2009 Dec;155(6 Suppl):S73-93.

Important Safety Information

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

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