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?

Understanding Exocrine Pancreatic Insufficiency (EPI)

People with EPI can’t properly digest food7

EPI 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.

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The pancreas and its role in the digestive system9

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 EPI8,10

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.

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

What is
EPI?

A condition where the
body can’t properly
digest food.7

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The causes
of EPI

Learn who's at risk
for having EPI.
 

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GI Specialist

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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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