PANCREAZE is a combination of porcine-derived lipases, proteases, amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

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37,000 unit dose available
Covered on the majority of commercial insurance plans.
37,000 unit dose available
Covered on the majority of commercial insurance plans.

What is EPI?

Could your chronic gastrointestinal issues be caused by EPI?

The most common symptoms of EPI are gastrointestinal — related to the stomach and digestion7,8

When you have Exocrine Pancreatic Insufficiency (EPI), your body is missing the enzymes it needs to properly digest food. This can cause important nutrients such as fats, proteins and carbohydrates to pass through the body unabsorbed and as a result, your body doesn’t get the nutrients it needs. In people with EPI, these undigested nutrients cause chronic gastrointestinal (GI) symptoms after eating.

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Could it be EPI?

Doctor Discussion Guide

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The most common symptoms of EPI7,8

Discuss with your doctor if you have one or more of the following chronic symptoms:

STOMACH PAIN: Gas and bloating resulting from poor digestion due to EPI can cause stomach pain.

DIARRHEA: Unabsorbed fats and nutrients in the small bowel draw in water and cause diarrhea.

GAS: Gas is made as the body breaks down food. Improper digestion can cause increased gas and flatulence.

UNEXPLAINED WEIGHT LOSS: This can occur when the body can’t absorb enough nutrients and fats.

BLOATING: Excess gas can cause the uncomfortable feeling of fullness in the abdomen.

GREASY STOOLS: Fat that isn’t digested can cause greasy, foul-smelling stools that float.

Real patient perspectives†

 

In a recent online survey, patients reported that before being diagnosed with EPI, their most troublesome symptoms were: diarrhea, stomach pain, oily stools and gas. Prior to their EPI diagnosis:

38%

Worried about interruptions from
urgent, unpredictable symptoms

39%

Reported being upset not knowing
what was causing their symptoms

†PANCREAZE Patient Survey: Online survey conducted in January 2023. Responses from 133 EPI patients and caregivers of patients with EPI. Respondents were not remunerated for their participation in the survey.

Download a FREE doctor discussion guide

We know it can be uncomfortable talking about gastrointestinal issues and subjects like bowel movements. We can help make the conversation easier. This document provides helpful tips to support you when speaking with your doctor about your chronic gastrointestinal issues and whether EPI could be the cause.

Download the free Could it Be EPI? doctor discussion guide

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The good news is that EPI is treatable. We’re here to help. Explore the following:

The causes
of EPI

Learn who's at risk
for having EPI.
 

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Free Discussion
Guide

We can help make the
conversation easier.
 

Download pdf

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available lookup tool.
 

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*Managed Markets Insight & Technology, LLC, database as of February 2024. Certain plans may require prior authorization.

Indication

PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food.

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. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.

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
  • 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?

  • Do not crush or chew the PANCREAZE capsules or their contents, and do not hold the capsule or contents in your mouth. Take PANCREAZE exactly as your doctor tells you. Read the Medication Guide for directions on how to give PANCREAZE to adults and children (children older than 12 months).
  • Read the Medication Guide for directions on how to give PANCREAZE to infants (children up to 12 months).

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; 2022. 2. CREON® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2023. 3. PERTZYE® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2022. 4. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 5. ZENPEP® Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2023. 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. 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 15. 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. doi:10.14740/jocmr3561w. 16. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved March 3, 2022, from https://www.cff.org/phthalates

Important Safety Information

PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.

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