Indication

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

To avoid irritation of oral mucosa, do not chew PANCREAZE or retain in the mouth.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PANCREAZE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Most common adverse reactions are: abdominal pain, flatulence, diarrhea, abnormal feces, and fatigue.

PANCREAZE is not interchangeable with any other pancrelipase products.

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

Please read the PANCREAZE Medication Guide and PANCREAZE Product Information.

References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2020. 2. CREON^® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2015. 3. PERTZYE^® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2017. 4. ULTRESA^® Full Prescribing Information. Bridgewater, NJ: Aptalis Pharma US, Inc; 2011. 5. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 6. ZENPEP^® Full Prescribing Information. Irvine, CA: Allergan USA, Inc; 2017. 7. 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):350-35 6. 8. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI), Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 9. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):2 9. 10. Fiekere A, et al. Enzymatic replacement therapy for pancreatic insufficiency: present and future. Clin Exper Gastroenterol. 2011;4:55- 73. 11. Ferrone MF, et al. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-9 20. 12. Keller J and Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(Suppl VI):v i1-vi 28. 13. Van der Haak N, Kench A. Chapter 10: pancreatic enzyme replacement therapy. In: Saxby N, King S, Kench A. Nutrition Guidelines for Cystic Fibrosis in Australia and New Zealand Administration Report. 2018.