Pancrelipase DR caps approved for EPI

August 10, 2012

FDA has approved pancrelipase delayed-release capsules to treat exocrine pancreatic insufficiency resulting from cystic fibrosis or other conditions.

Pancrelipase delayed-release capsules(Pertzye, Digestive Care, Inc.)

Efficacy. The short-term efficacy of Pertzye was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 24 patients with EPI caused by cystic fibrosis. Subjects received an individually titrated dose of Pertzye (≤2,500 lipase units/kg/meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days. The mean coefficient of fat absorption was 83% with Pertzye compared to 46% with placebo (difference of 36%, 95% CI, 28%–45%; P<.001). The mean change in coefficient of nitrogen absorption also favored Pertzye, compared to placebo (difference of 32%; P<.05).

Dosing. The dosage of Pertzye should be individualized based on clinical symptoms, the degree of steatorrhea present, and fat content of the patient's diet. It should be initiated at the lowest recommended dose and gradually increased. Specific dosing guidance has been published by the Cystic Fibrosis Foundation. In general, for children >12 months and younger than 4 years of age and weighing ≥8 kg, dosing should begin at 1,000 lipase units/kg of body weight/meal to a maximum of 2,500 lipase units/kg/meal, ≤10,000 lipase units/kg/day, and <4,000 lipase units/g fat ingested/day. Adults and children ≥4 years of age and weighing ≥16 kg should begin with 500 lipase units/kg/meal with similar limits. Half of the prescribed dose given for an individual full meal should be taken with each snack. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended.