Important Safety Information Full Prescribing Information Medication Guide

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

Dosing based on your specific needs

PANCREAZE is available in 6 strengths, including a 37,000 unit dose¹

All 6 doses of PANCREAZE use a phthalate-free formulation.² PANCREAZE’s flexible dosing options ensure targeted dosing for each patient’s unique needs. Your doctor will individualize your dose based on age, weight, and symptoms — making sure you get the dose that’s right for you.

2,600-37,000 USP

2,600-37,000 USP

The 37,000 unit dose may be a convenient, appropriate option for many EPI patients. Ask your healthcare provider if this dose could be right for you.

PANCREAZE should be taken with
every meal and snack¹

Effective dosing strategies will vary by patient. Your doctor will advise you on how to take PANCREAZE — this may be the entire dose at once or divided throughout your meal. Always take PANCREAZE exactly as recommended by your doctor. For some patients, splitting the dose over the course of a meal may be an optimal strategy for effective digestion.⁶

Taking or administering
PANCREAZE correctly¹

FOR CHILDREN OVER 12 MONTHS AND ADULTS:

Take PANCREAZE with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.
Do not crush or chew the capsules or their contents or hold the capsule or contents in your mouth. Crushing, chewing or holding the PANCREAZE capsules in your mouth may cause irritation in your mouth or change the way PANCREAZE works in your body.

FOR CAREGIVERS OF INFANTS (CHILDREN UP TO 12 MONTHS):

Administer immediately prior to each feeding
Do not mix directly with formula or breast milk as this may diminish eﬃcacy
Sprinkle on a small amount of acidic soft food with a pH of 4.5 or less. Sprinkle the capsule contents directly into the infant’s mouth.

UNABLE TO SWALLOW THE CAPSULES?

If you or your child is unable to swallow the capsules, you can sprinkle the contents on soft acidic food (e.g., applesauce, orange juice, crushed blueberries).
Drink water or juice immediately after to ensure complete ingestion. Care should be taken to ensure no drug is retained in the mouth.

For additional information about PANCREAZE, please see our FAQs

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*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.

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. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved March 3, 2022, from https://www.cff.org/phthalates 3. Cleveland Clinic. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://my.clevelandclinic.org/health/diseases/21577-exocrine-pancreatic-insufficiency-epi 4. Othman MO, et al. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72:e13066. 5. Cleveland Clinic. (n.d.). Pancreas. Retrieved from https://my.clevelandclinic.org/health/body/21743-pancreas 6. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):29. 7. The National Pancreas Foundation (n.d.). About Chronic Pancreatitis. Retrieved from https://pancreasfoundation.org/patient-information/chronic-pancreatitis/ 8. 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. 9. 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. 10. Singh VK, Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol. 2017 Oct 21;23(39):7059-7076. 11. Mayo Clinic. (n.d.). Gastric bypass (Roux-en-Y). Retrieved from https://www.mayoclinic.org/tests-procedures/gastric-bypass-surgery/about/pac-20385189 12. 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 13. Vujasinovic M, et al. Pancreatic Exocrine Insufficiency after Bariatric Surgery. Nutrients. 2017 Nov 13;9(11):1241. 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

Important Safety Information

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.

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