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.

WHAT SYMPTOM CONTROL CAN LOOK LIKE. Now with a 37,000 unit dose!

WHAT SYMPTOM CONTROL CAN LOOK LIKE. Now with a 37,000 unit dose!

What is EPI?

Other medical conditions
are typically the cause of EPI

The two most common conditions that lead to Exocrine Pancreatic Insufficiency (EPI) are:

1

Chronic pancreatitis (CP) is the leading cause of EPI. It is progressive and is often diagnosed later in adulthood (typically between 30-40 years of age). As many as 8 in 10 adults with CP develop EPI.^8,11,12

2

Cystic fibrosis (CF) is an inherited disease that affects approximately 30,000 people in the United States. Approximately 66% of CF patients develop EPI shortly after birth. This number jumps to 85% by one year of age.^8,9,10

Other conditions that may be associated with EPI include:¹¹

Irritable Bowel Syndrome (IBS)
Crohn’s disease
Ulcerative colitis
Celiac disease
Type 1 and 2 Diabetes

It’s important to share your complete medical history with your doctor when asking about your symptoms.

Download free resources from the Talking with Your Doctor About EPI section. These materials can help make the conversation easier.

DOWNLOAD A FREE GUIDE!

We’re here to help. Download, complete and share this Discussion Guide with your healthcare provider.

Certain other diseases and conditions can put you at risk for having EPI.^11,15

It is estimated that EPI affects up to:

14%

of people with Crohn’s disease

22%

of people with ulcerative colitis

44%

of people with type 1 diabetes

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.

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EPI symptoms

Let’s talk about the symptoms of EPI.

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Talking to your doctor

Download materials to make the conversation easier.

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*Managed Markets Insight & Technology, LLC, database as of October 2022. 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; 2021. 2. CREON^® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2022. 3. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2020. 4. ULTRESA^® Full Prescribing Information. Bridgewater, NJ: Aptalis Pharma US, Inc; 2014. 5. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 6. ZENPEP^® Full Prescribing Information. Bridgewater, NJ: Nestlé HealthCare Nutrition, Inc; 2020. 7. Pezilli R, et al. Exocrine pancreatic insufficiency in adults: A shared position statement of the Italian association for the study of the pancreas. World J Gastroenterol 2013;19 (44):7930-7946. 8. Lindkvist B. Diagnosis and treatment of pancreatic exocrine insufficiency. World J Gastroenterol. 2013;19(42):7258-7266. 9. The Cystic Fibrosis Foundation (n.d.). About Cystic Fibrosis. Retrieved from https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/ 10. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):29. 11. Othman MO, et al. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. .2018;72:e13066. 12. The National Pancreas Foundation (n.d.). About Chronic Pancreatitis. Retrieved from https://pancreasfoundation.org/patient-information/chronic-pancreatitis/ 13. 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 14. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved from https://www.cff.org/phthalates 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. Cleveland Clinic. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://my.clevelandclinic.org/health/diseases/21577-exocrine-pancreatic-insufficiency-epi 17. Everyday Health. January 2, 2020. 5 Symptoms of Exocrine Pancreatic Insufficiency. Retrieved from https://www.everydayhealth.com/hs/exocrine-pancreatic-insufficiency/know-the-symptoms-of-epi/ 18. Loma Linda University Health. (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://lluh.org/conditions/exocrine-pancreatic- insufficiency-epi

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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