Important Safety Information Full Prescribing Information Medication Guide

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

PANCREAZE Engage offers a
comprehensive range of benefits

Members can save monthly on a range of nutritional products

PANCREAZE Engage offers monthly savings on a wide selection of vitamins and nutritional supplements formulated for EPI patients deficient in vitamins A, D, E and K.^†

Every month you will receive a new single-use savings code that you can redeem at the VIVUS Health Store. Simply order online at the VIVUS Health Store, redeem your savings code and the products will be shipped directly to your home for FREE — offering you peace of mind.

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Save on the cost of your medication
with the PANCREAZE Savings Card

PANCREAZE Engage members automatically receive a PANCREAZE savings card. This lets patients and caregivers save monthly on the cost of their medication.

Commercially-insured patients can pay as little as $0 on their co-pay for their PANCREAZE prescription.*
Save up to $2,000 per prescription fill with a maximum yearly benefit of $3,500. Out-of-pocket expenses may vary.*

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PANCREAZE Engage also offers help for eligible PANCREAZE patients unable to pay for their medication. Eligible patients can apply for assistance and receive their medication at no-cost.^‡

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*Patient Co-Pay Eligibility, Terms, and Conditions

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. Patient Instructions: In order to redeem the offer, you must have a valid prescription for PANCREAZE. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions below.

Terms and conditions: Offer is not transferable. Patients are not eligible if they are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE. Only valid in the United States, Puerto Rico, Guam and the U.S. Virgin Islands. Offer void where prohibited by law, taxed, or restricted. Other restrictions may apply. This program is not health insurance. VIVUS LLC has the right to rescind, revoke, or amend this program at any time without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage and that you will report the value received if required by your insurance provider. When you use this card, you are certifying that you understand and will comply with the program rules, terms, and conditions.

^†Online VIVUS Health Store and Program Terms

VIVUS provides eligible PANCREAZE patients or caregivers of eligible patients under the age of 18, a monthly discount. Eligible patients or caregivers of eligible patients will be issued Shopify single-use savings codes on a monthly basis that can be redeemed and applied to the purchase of products available in the VIVUS Health Store. VIVUS reserves the right to expire these savings codes at any time, delete or modify the amount of the benefit, and change the products offered in its store. By registering for the PANCREAZE Engage program, and by using this site, you are authorizing VIVUS or its designee to contact you by telephone, direct mail or email in order to receive the benefits and verify continued eligibility. VIVUS reserves the right to revoke eligibility and access to these monthly codes based upon proof of prescription and/or PANCREAZE use. Offer limited to one PANCREAZE Engage account per household.

^‡PANCREAZE Patient Assistance Program Requirements

The patient does not have insurance or their medication is not covered
- Please note, some patients with Medicare Prescription Drug Coverage (Part D) who cannot afford their medication and who meet certain financial criteria may also be eligible for assistance
  - In order to qualify for the program, the patient must spend 4% or more of their gross annual income on prescription drugs
The patient’s income level is equal to or less than 300% above the U.S. Federal Poverty Guidelines
The patient lives in the United States or a U.S. Territory
The patient is being treated for EPI by a U.S. licensed healthcare provider as an outpatient

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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