Indication(s):

Exocrine pancreatic insufficiency (eg, cystic fibrosis).

Pharmacology:

Pancrelipase is a group of digestive enzymes including lipases, amylases, and proteases. These enzymes catalyze the hydrolysis of fats to monoglycerol, glycerol and fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars in the duodenum and proximal small intestine.

Zenpep is a pancrelipase product that is prepared from an extract of porcine pancreatic glands. The capsules contain enteric-coated beads that vary in diameter and activity levels. The coating is designed to protect the enzymes from gastric acids and to release the enzymes at a pH of 5.5 or greater.

Clinical Trials:

Study 1 involved 34 patients ages 7 to 23 years with exocrine pancreatic insufficiency associated with cystic fibrosis. In this double-blind crossover study, patients were randomized to either Zenpep or matching placebo for 6 or 7 days, followed by crossover to the alternative treatment for another 6 to 7 days. The mean dose ranged from 3900 to 5700 lipase units/kg per day. All patients consumed a high-fat diet during treatment. The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA) between Zenpep and placebo. Mean CFA for Zenpep was 88% compared to 63% with placebo treatment.

In study 2, an open-label, uncontrolled study in 19 patients 1 to 6 years of age, compared fat malabsorption before and after Zenpep administration with meals/snacks. Patients were switched to Zenpep from their usual treatment. Following a screening period on their usual treatment, patients were given Zenpep at individually titrated doses ranging from 2300 to 10000 lipase units/kg per day for 14 days. Patients showed similar control of fat malabsorption by spot fecal fat testing when switched to Zenpep treatment at similar doses.

Legal Classification:

Rx

Adults & Children:

Base dose on lipase units. Swallow whole (do not crush); may mix contents with applesauce or other acidic food, follow with water or juice; take with meals; do not let any drug remain in mouth. Infants: 2000–4000 units per 120mL formula or per breast-feeding (do not mix directly into formula or breast milk); 12mos–4yrs: 1000 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day); >4yrs: 500 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day), or <4000 units/g fat ingested per day. Adjust per diet and clinical response (eg, steatorrhea).

Warnings/Precautions:

Not interchangeable with similar products. Gout. Renal impairment. Hyperuricemia. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s):

Abdominal pain, flatulence, headache, cough, decreased weight, early satiety, contusion; fibrosing colonopathy, hyperuricemia, allergic reactions.

How Supplied:

Caps (5000, 10000, 15000 lipase units)—12, 100
20000 lipase units—12, 100, 500

Last Updated:

9/13/2010