Important Safety Information Full Prescribing Information Medication Guide

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

Is PANCREAZE covered on your patient’s commercial insurance plan?

Check your patient’s commercial insurance coverage using our online lookup tool

PANCREAZE is a preferred brand on multiple plans^§

Preferred for Cigna Healthcare
Commercial Formularies^¶

No prior authorization or step requirements

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Powered by: Managed Markets Insight & Technology, LLC

^§Managed Markets Insight & Technology, LLC, database as of January 2026. Certain plans may require prior authorization.

^¶This is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. Nothing herein may be construed as an endorsement, approval, recommendation, representation or warranty of any kind by any plan or insurer referenced herein.

SELECT FROM THE FOLLOWING

PANCREAZE 37,000

Can be a convenient, appropriate dose for many EPI patients.

SEE DOSING GUIDE

PANCREAZE Engage

Offers your patients a comprehensive range of benefits.

*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. Out-of-pocket expenses may vary. 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.

^†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

^‡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.

Indication

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

Important Safety Information

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

Hyperuricemia has been reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.

Irritation of the oral mucosa may occur due to loss of protective enteric coating on the capsule contents.

The presence of porcine viruses that might infect humans cannot be definitely excluded.

Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.

Please read the PANCREAZE Medication Guide and PANCREAZE Product Information.

References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS LLC; 2024. 2. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved from https://www.cff.org/phthalates. 3. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 4. Othman MO, Harb D, Barkin JA. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72:e13066. 5. Whitcomb, DC, Buchner, AM, Forsmark, CE. AGA Clinical Practice Update on the Epidemiology, Evaluation, and Management of Exocrine Pancreatic Insuﬃciency: Expert Review. Gastroenterology. 2023;165:1292–1301. 6. 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. 7. 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. 8. Radlinger B, Ramoser, G and Kaser S. Exocrine Pancreatic Insufficiency in Type 1 and Type 2 Diabetes. Current Diabetes Reports. 2020;20:18. 9. Martin TCS, Scourfield A, Rockwood N, et al. Pancreatic insufficiency in patients with HIV infection: role of didanosine questioned. HIV Medicine (2013),14,161-166. 10. Price DA, Schmid ML, Ong ELC, et al. Pancreatic exocrine insufficiency in HIV-positive patients. HIV Medicine (2005),6,33–36. 11. Vujasinovic M, Valente R, Thorell A, et al. Pancreatic Exocrine Insufficiency after Bariatric Surgery. Nutrients. 2017 Nov 13;9(11):1241. 12. Uribarri-Gonzalez L, Nieto-García L, Martis-Sueiro A, 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. Struyvenberg MR, Martin CR, Freedman SD. Practical guide to exocrine pancreatic insufficiency – Breaking the myths. BMC Med. 2017; 15(1): 29. 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. 15. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 16. CREON^® Full Prescribing Information. Chicago, IL: AbbVie, Inc; 2024. 17. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2024. 18. VIOKACE™ Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2024. 19. ZENPEP^® Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2025. 20. Brennan GT, Saif MW. Pancreatic Enzyme Replacement Therapy: A Concise Review. JOP. 2019;20(5):121-125. 21. Barkin JA, Harb D, Kort J, Barkin J. Real-World Patient Experience With Pancreatic Enzyme Replacement Therapy in the Treatment of Exocrine Pancreatic Insufficiency. Pancreas. 2024 Jan 1;53(1). 22. Johns Hopkins Cystic Fibrosis Center. (n.d.). Effects of CF. Retrieved from https://hopkinscf.org/knowledge/effects-of-cf/ 23. Cystic Fibrosis Foundation. Cystic Fibrosis Foundation evidence-based guidelines for management of infants with cystic fibrosis. J Pediatr. 2009 Dec;155(6 Suppl):S73-93.

Important Safety Information

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

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