Important Safety Information Full Prescribing Information Medication Guide

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

Is your patient a candidate for
PANCREAZE 37,000?¹

PANCREAZE 37,000 can be a convenient, appropriate dose for many EPI patients
— minimizing the number of capsules they take daily.

The following guide highlights the minimum and
maximum range of 37,000 unit capsules by patient weight range:

Patient
Weight (lbs)

110-130

131-163

164-195

196-228

≥ 229

Minimum Dose
Per Snack

1

1

1

1

1

Capsules Per
Meal (min-max)

1-3

1-4

2-5

2-6

2-7

Patient
Weight
(lbs)

Capsules
Per Snack
(min)

Capsules
Per Meal
(min-max)

110-130

1

1-3

131-163

1

1-4

164-195

1

2-5

196-228

1

2-6

≥ 229

1

2-7

This chart is intended as a guide only.
PANCREAZE should be initiated at the lowest recommended dose and gradually increased.
For children 4 years and older and adults, dosing should begin with 500 lipase units/kg of body weight per meal up to a maximum of 2,500 lipase units/kg of body weight per meal.
The number of capsules represent nearest pill count within the recommended range.
Patients weighing <110 lbs may require a lower lipase unit starting dose.
Patients weighing >230 lbs may require a higher lipase unit starting dose and have a higher per-meal maximum dose.
Do not substitute other pancreatic enzyme products for PANCREAZE.
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.

PANCREAZE 37,000 Prescribing Scenario

PANCREAZE® (pancrelipase) 37,000 lipase units. 2 capsules p.o. during each meal. 1 capsule p.o. during each snack. 30-day total: 240 capsules. Note: Take during every meal and snack.

Prescribe PANCREAZE for both meals and snacks

SCENARIO: Initiating treatment of 175 lb patient

Patient initiated on treatment at 500 lipase units/kg/meal (39,690 USP lipase units per meal).
Based on the patient’s weight, this patient can take: 2-4 capsules per meal and 1-2 capsules per snack.
Mealtime dose can vary based on symptoms and the fat content and volume of the meal ingested.

Please review the appropriate doses for your patient’s individual dietary needs.

For all PANCREAZE strengths, prescriptions should be written to be dispensed in multiples of 100 capsules.

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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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