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

Mechanism of Action

PANCREAZE replaces enzymes that are normally secreted by the pancreas¹

All doses of PANCREAZE are made up of 2mm diameter microtablets to assist with their mixing with stomach contents and absorption

PANCREAZE contains a mixture of lipases, proteases, and amylases that mimic the digestive enzymes normally secreted by the pancreas. The enteric-coated microtablets in PANCREAZE are formulated to protect their enzymes from the acidic stomach environment and to delay the release of enzymes until they reach the duodenum.

The lipases, proteases, and amylases in PANCREAZE catalyze:
- The hydrolysis of fats to monoglyceride, glycerol and free fatty acids
- Proteins into peptides and amino acids
- Starches into dextrins and short chain sugars such as maltose and maltriose
The enzymes in PANCREAZE catalyze in the duodenum and proximal small intestine thereby acting like the digestive enzymes normally secreted by the pancreas.

PANCREAZE Engage offers a comprehensive collection of savings and support.

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This tool can help with your PANCREAZE dosing considerations.

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Use our convenient, online lookup tool to check a patient’s coverage.

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Learn more and access the following:

PANCREAZE HCP Resource Center

Request materials, a rep call, or order samples of the 37,000 unit dose

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*Managed Markets Insight & Technology, LLC, database as of February 2023. Certain plans may require prior authorization.

^†Patient Co-Pay Eligibility, Terms, and Conditions

Eligible patients may pay a minimum of $0 and receive up to $100 off the patient’s co-pay or out-of-pocket expenses for a 30‑day supply or $300 off for a 90-day supply of PANCREAZE (pancrelipase) capsules. 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.

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. Trapnell BC, et al. Efficacy and safety of PANCREAZE for treatment of exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 011;10(5):350-356. 3. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 4. 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. 5. 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. 6. Crohn’s and Colitis Foundation (n.d). IBS vs IBD. Retrieved from https:/www.crohnscolitisfoundation.org/what-is-ibd/ibs-vs-ibd 7. Crohn’s and Colitis Foundation (n.d). Signs and Symptoms of Crohn’s Disease. Retrieved from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms 8. Kaitha S, Bashir M, Ali T. Iron deﬁciency anemia in inﬂammatory bowel disease. World J Gastrointest Pathophysiol. 2015 August 15; 6(3): 62-72. 9. Perler et al. Presenting symptoms in inﬂammatory bowel disease: descriptive analysis of a community-based inception cohort. BMC Gastroenterology (2019); 19:47. 10. 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. 11. Crohn’s and Colitis Foundation (n.d). Signs and Symptoms of Ulcerative Colitis. Retrieved from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms 12. Freeman HJ. Iron deficiency anemia in celiac disease. World J Gastroenterol. 2015 August 21; 21(31):9233-9238. 13. Zaidel O, Lin HC. Uninvited Guests: The Impact of Small Intestinal Bacterial Overgrowth on Nutritional Status. Practical Gastroenterology. 2003; Nutrition Issues in Gastroenterology, Series #7: 23-34. 14. Struyvenberg MR, Martin CR, Freedman SD. Practical guide to exocrine pancreatic insufficiency – Breaking the myths. BMC Med. 2017; 15(1): 29. 15. Al-Kaade S (2020, February 3). What causes anemia in exocrine pancreatic insufficiency (EPI)? Medscape. Retrieved from https://www.medscape.com/answers/2121028-18736/what-causes-anemia-in-exocrinepancreatic-insufficiency-epi 16. Vujasinovic M, Valente R, Thorell A, Rutkowski W, Haas SL, Arnelo U, Martin L, Löhr JM. Pancreatic Exocrine Insufficiency after Bariatric Surgery. Nutrients. 2017 Nov 13;9(11):1241. 17. Uribarri-Gonzalez L, Nieto-García L, Martis-Sueiro A, Dominguez-Muñoz JE. 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. 18. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI). Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 19. Cystic Fibrosis Foundation. (n.d.). Phthalates. Retrieved from https://www.cff.org/phthalates. 20. CREON^® Full Prescribing Information. Chicago, IL: AbbVie, Inc; 2024. 21. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2024. 22. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 23. ZENPEP^® Full Prescribing Information. Bridgewater, NJ: Aimmune Therapeutics, Inc; 2024.

Important Safety Information

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PANCREAZE replaces enzymes that are normally secreted by the pancreas¹

All doses of PANCREAZE are made up of 2mm diameter microtablets to assist with their mixing with stomach contents and absorption

Patient
Savings and
Support

PANCREAZE Dosing
Calculator

Check
PANCREAZE
insurance coverage

PANCREAZE HCP Resource Center

PANCREAZE replaces enzymes that are normally secreted by the pancreas1

All doses of PANCREAZE are made up of 2mm diameter microtablets to assist with their mixing with stomach contents and absorption

Patient Savings and Support

PANCREAZE Dosing Calculator

Check PANCREAZE insurance coverage

PANCREAZE HCP Resource Center

PANCREAZE replaces enzymes that are normally secreted by the pancreas¹

Patient
Savings and
Support

PANCREAZE Dosing
Calculator

Check
PANCREAZE
insurance coverage