FAQs

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.

Yes. In the pivotal trial, patients with EPI due to CF achieved a near normal (≥85%) mean coefficient of fat absorption (CFA) of 88.3% with ZENPEP vs 62.8% with placebo (primary endpoint).^1,2

Signs and symptoms of maldigestion or malabsorption associated with EPI include steatorrhea, abdominal pain, bloating, flatulence, or weight loss. Symptoms include frequent, soft, watery, bulky, oily, foul-smelling stools, or diarrhea.²³

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 therapy.^3.4-7

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

Dosage

• ZENPEP is not interchangeable with any other pancrelipase product.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 diet.

Infants (up to 12 months)

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

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 day

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 fat ingested per day
• 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 day

Limitations on Dosing

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

For further information on dosing and administartion, 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.