Important Safety Information Full Prescribing Information Medication Guide

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

Understanding EPI³

EPI (Exocrine Pancreatic Insufficiency) is a condition that occurs when the pancreas is unable to provide the enzymes needed to digest food. When you have exocrine pancreatic insufficiency the body can’t properly digest and absorb fats, proteins, and carbohydrates from the food you eat.

This means that after you eat, food passes through your system without being fully digested and can cause troublesome gastrointestinal symptoms. Additional complications that can result from EPI include muscle loss, skin problems, brittle nails and hair loss.

The pancreas and its role in the digestive system⁵

The pancreas is a pear-shaped organ in the back of the abdomen (belly) behind the stomach. It is about 6 inches long and is part of the digestive system. It produces enzymes that help with digestion and sends out hormones that control the amount of sugar in the bloodstream.

Digestive system diagram

PANCREAS

The gland that produces digestive enzymes runs the length of the pancreas.

When food enters the stomach, the pancreas releases the enzymes into small tubes that flow into the main pancreatic duct.

The pancreas produces three types of enzymes to help digest food:

Lipase: Works with bile (a fluid produced by the liver) to break down fats.
Amylase: Breaks down carbohydrates for energy.
Protease: Breaks down proteins

Treating and managing EPI^4,6

EPI is diagnosed based on a combination of patient history, symptoms and specific laboratory tests. The symptoms of EPI can be similar to other digestive conditions — which can complicate the process of diagnosing it. The primary treatment for EPI is called pancreatic enzyme replacement therapy (PERT). This is a therapy that replaces the enzymes your pancreas isn't making — a prescription medication taken every time you eat.

There’s no one-size-fits-all approach to treating EPI. In addition to enzyme replacement therapy, EPI patients can benefit from working with their doctor or a registered dietitian to manage their diet. This ensures they are receiving the right nutrients and their chronic symptoms are controlled.

Get a free Discussion Guide

We can help make the conversation easier

This document provides helpful tips to support you when speaking with your doctor about your chronic stomach and digestive issues — and whether EPI could be the cause.

SELECT FROM THE FOLLOWING

Taking PANCREAZE

Taken with every meal and snack, effective dosing strategies will vary by patient.

HOW TO TAKE PANCREAZE

Save on PANCREAZE!

Sign up and get a PANCREAZE Savings Card and explore other savings offers!

*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.

VIEW ALL +