Frequently Asked Questions

ZENPEP (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF), or other conditions.1

Yes. In the pivotal trial, patients with EPI due to CF achieved a near-normal mean coefficient of fat absorption of 88.3% with ZENPEP vs 62.8% with placebo (primary endpoint).1-3

Signs and symptoms of maldigestion or malabsorption associated with EPI include: frequent soft, watery, bulky, oily, foul-smelling stools; diarrhea; abdominal pain; bloating; flatulence; or weight loss.2,4-6

In addition to the treatment of causative factors, there are 2 key goals for managing EPI: improving digestion and absorption of nutrients, and relieving GI signs and symptoms of EPI. Management includes lifestyle and dietary modifications, vitamin and nutrient supplementation, and pancreatic enzyme replacement therapy.6-8

No. Concomitant agents such as proton pump inhibitors, H2-antagonists, or motility agents were excluded from the trials.2

Dosage

  • ZENPEP is not interchangeable with any other pancrelipase product. ZENPEP is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of ZENPEP should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet1

Infants (up to 12 months)

  • Infants may be given 3,000 lipase units (1 capsule) per 120 mL of formula or per breastfeeding1
  • Do not mix ZENPEP capsule contents directly into formula or breast milk prior to administration1

Children Older Than 12 Months and Younger Than 4 Years

  • Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day1

Children 4 Years and Older and Adults

  • Enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g of fat ingested per day1
  • Usually half of the prescribed ZENPEP dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately 3 meals plus 2 or 3 snacks per day1

Limitations on Dosing

  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines1

For further information on dosing and administration, please see ZENPEP full Prescribing Information.

In an open-label, uncontrolled trial (N=19) in patients aged 1 to 6 years with EPI due to CF, patients showed similar control of fat malabsorption (spot fecal fat testing) and symptoms of malabsorption with ZENPEP as with their previous enzyme. ZENPEP is not interchangeable with any other pancrelipase product.1

CF=cystic fibrosis; EPI=exocrine pancreatic insufficiency; GI=gastrointestinal.

References: 1. ZENPEP. Package insert. Nestlé Health Science; 2020. 2. Wooldridge JL, Heubi JE, Amaro-Galvez R, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009;8(6):405-417. doi:10.1016/j.jcf.2009.07.006 3. Borowitz D, Konstan MW, O'Rourke A, Cohen M, Hendeles L, Murray FT. Coefficients of fat and nitrogen absorption in healthy subjects and individuals with cystic fibrosis. J Pediatr Pharmacol Ther. 2007;12(1):47-52. doi:10.5863/1551-6776-12.1.47 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(2):e13066. doi:10.1111/ijcp.13066 5. Domínguez-Muñoz JE. Chronic pancreatitis and persistent steatorrhea: what is the correct dose of enzymes? Clin Gastroenterol Hepatol. 2011;9(7):541-546. doi:10.1016/j.cgh.2011.02.027 6. Ockenga J. Importance of nutritional management in diseases with exocrine pancreatic insufficiency. HPB (Oxford). 2009;11(suppl 3):11-15. doi:10.1111/j.1477-2574.2009.00134.x 7. Alkaade S, Vareedayah AA. A primer on exocrine pancreatic insufficiency, fat malabsorption, and fatty acid abnormalities. Am J Manag Care. 2017;23(suppl 12):S203-S209. 8. Perbtani Y, Forsmark CE. Update on the diagnosis and management of exocrine pancreatic insufficiency. F1000Res. 2019;8:F1000 Faculty Rev-1991. doi:10.12688/f1000research.20779.1