For the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions

About PERTZYE® (pancrelipase)

PERTZYE microspheres are formulated to simulate normal pancreatic digestive function1-4

PERTZYE microspheres contain 3 types of pancreatic enzymes: lipase, amylase, and protease.3 These enzymes are buffered with bicarbonate, which may help to optimize the microenvironment pH.2

PERTZYE (pancrelipase) microspheres

Bicarbonate buffer

may help optimize enzyme activity5,6

Enteric-coated microspheres

to bypass gastric acid3

Varying sizes

to extend the window of enzyme release7,8

PERTZYE does not require concomitant use of acid-suppressing drugs.3

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

“Poor dissolution of the enteric coating and release of the enzymes all at once are factors contributing to a poor response to therapy.”9 — CF Foundation Consensus Conferences

Discover how PERTZYE works within the digestive system1-4

Stomach

Duodenum

Pancreas

Pancreatic
enzymes and
bicarbonate

Stomach

Duodenum

Pancreas

Pancreatic
enzymes and
bicarbonate

Stomach

Duodenum

Pancreas

Pancreatic
enzymes and
bicarbonate

Healthy digestive system The role of the exocrine
pancreas in healthy
individuals
CF patients with EPI Pancreatic function in patients with EPI
The PERTZYE difference How PERTZYE works

For illustrative purposes only.


Healthy digestive system The role of the exocrine pancreas in healthy individuals

CF patients with EPI Pancreatic function in patients with EPI

The PERTZYE difference How PERTZYE works

Play video to see how PERTZYE (pancrelipase) works in the digestive system

Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.

Pancreatic enzymes are affected by pH

Lipase, one of the key ingredients of PERT, requires a neutral to alkaline pH for optimal activity10

  • Lipase activity decreases as pH decreases, and is likely to be irreversibly inactivated below a pH of 411
  • The duodenal pH in people with EPI due to CF is more acidic than in healthy people9, 12, 13
A pH scale that shows the duodenal pH in people with EPI due to CF vs healthy people
Significant results in fat and protein absorption3, 14

Proton pump inhibitors (PPIs) may not be the right fit for all cystic fibrosis patients

PPIs are sometimes used in conjunction with PERTs to reduce gastric acidity and indirectly affect duodenal pH.9,15,16

PPIs lack sufficient evidence showing they affect the efficacy of PERTs

An analysis of clinical trial data suggests that concomitant use of PPIs with PERTs does not improve efficacy, as determined by fat absorption values at the end of treatment.17

PPIs are associated with increased risk of adverse consequences*

The adjunctive use of PPIs and H2 antagonists may be associated with:

  • Increased risk of community- and hospital-acquired pneumonia18
  • Increased risk of Clostridium difficile–associated diarrhea19
  • Osteoporosis-related bone fractures20
  • Risk of dementia21
  • Chronic kidney disease22

Adding a PPI increases pill burden and may affect patient compliance23

*Adverse consequences are not specific to patients with cystic fibrosis.

Important Safety Information

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

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

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

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

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

Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.

Indication

PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Please click here for Full Prescribing Information and Medication Guide.


References: 1. Borowitz D, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2002;35(3):246-259. 2. Manual of Clinical Enzyme Measurements. Freehold, NJ: Worthington Biochemical Corporation; 1972:1-56. 3. PERTZYE (pancrelipase) Prescribing Information. Digestive Care, Inc., Bethlehem, PA: July 2017. 4. Ishiguro H, Steward MC, Naruse S, et al. CFTR functions as a bicarbonate channel in pancreatic duct cells. J Gen Physiol. 2009;133(3):315-326. 5. Data on file. Digestive Care, Inc. 6. Rizwan AN, Criste R, Nebot N, et al. Use of a multilumen catheter to assess the bioavailability of an enteric-coated high-buffered pancrelipase formulation in patients with exocrine pancreatic insufficiency. J Bioequiv Availab. 2011;3(2):26-31. 7. Meyer JH, Elasho J, Porter-Fink V, Dressman J, Amidon GL. Human postprandial gastric emptying of 1-3 millimeter spheres. Gastroenterology. 1988;94(6):1315-1325. 8. Kim K, Pack DW. Microspheres for drug delivery. In: Ferrari M, Lee AP, Lee J, eds. BioMEMS and Biomedical Nanotechnology. New York, NY: Springer US; 2006:19-50. 9. Borowitz DS, Grand RJ, Durie PR. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Consensus Committee. J Pediatr. 1995;127(5):681-684. 10. Bergmeyer HU, ed. Methods of Enzymatic Analysis. Vol 2. 2nd ed. New York, NY: Academic Press, Inc.; 1974:814-823. 11. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 12. Youngberg CA, Berardi RR, Howatt WF, et al. Comparison of gastrointestinal pH in cystic fibrosis and healthy subjects. Dig Dis Sci. 1987;32(5):472-480. 13. Abrams CK, Hamosh M, Hubbard VS, Dutta SK, Hamosh P. Lingual lipase in cystic fibrosis. Quantitation of enzyme activity in the upper small intestine of patients with exocrine pancreatic insufficiency. J Clin Invest. 1984;73(2):374-382. 14. Konstan MW, Accurso FJ, Nasr SZ, Ahrens RC, Graff GR. Efficacy and safety of a unique enteric-coated bicarbonate-buffered pancreatic enzyme replacement therapy in children and adults with cystic fibrosis. Clin Invest. 2013;3(8):723-729. 15. Tran TMD, Van den Neucker A, Hendriks JJE, Forget P, Forget P-Ph. Effects of a proton-pump inhibitor in cystic fibrosis. Acta Paediatr. 1998;87(5):553-558. 16. Proesmans M, De Boeck K. Omeprazole, a proton pump inhibitor, improves residual steatorrhoea in cystic fibrosis patients treated with high dose pancreatic enzymes. Eur J Pediatr. 2003;162(11):760-763. 17. Sander-Struckmeier S, Beckmann K, Janssen-van Solingen G, Pollack P. Retrospective analysis to investigate the effect of concomitant use of gastric acid-suppressing drugs on the efficacy and safety of pancrelipase/pancreatin (CREON) in patients with pancreatic exocrine insufficiency. Pancreas. 2013;42:983-989. 18. Eom C-S, Jeon CY, Lim J-W, Cho E-G, Park SM. Use of acid suppressive drugs and risk of pneumonia: a systematic review and meta-analysis. CMAJ. 2011;183(3):310-319. 19. US Food and Drug Administration. FDA drug safety communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). February 8, 2012. http://www.fda.gov/drugs/drugsafety/ucm290510.htm. Accessed October 25, 2018. 20. Targownik LE, Lix LM, Metge CJ, Prior HJ, Leung S, Leslie WD. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008;179(4):319-332. 21. Gomm W, Von Holt K, Thome F, et al. Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological claims data analysis. JAMA Neurol. 2016;73(4):410-416. 22. Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016;176(2):238-246. 23. Sawicki GS, Sellers DE, Robinson WM. High treatment burden in adults with cystic fibrosis: challenges to disease self-management..J Cyst Fibros. 2009;8(2):91-96.