Date: May 18, 2012 Author: Formulary staff Source: Formulary Journal (
click here to go to the source)
On May 18, 2012, FDA approved pancrelipase delayed-release capsules (Pertzye, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI ) due to cystic fibrosis or other conditions. Pertzye, which is a combination of porcine-derived lipases, proteases, and amylases, is the sixth pancrelipase product to be approved by FDA. It is not interchangeable with other pancrelipase products.
Efficacy. The short-term efficacy of pancrelipase delayed-release capsules was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 24 patients with EPI due to cystic fibrosis. Subjects received an individually titrated dose of pancrelipase delayed-release capsules (≤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 pancrelipase delayed-release capsules compared to 46% with placebo (difference of 36%, 95% CI, 28%--45%; P<.001). The mean change in coefficient of nitrogen absorption also favored pancrelipase delayed-release capsules as compared to placebo (difference of 32%; P<.05).
Safety. The short-term safety of pancrelipase delayed-release capsules was assessed in the same crossover study. The most common adverse reactions (occurring in ≥10% of subjects) observed in the clinical trial were diarrhea, dyspepsia, and cough. Delayed- and immediate-release pancreatic enzyme products with the same active ingredient (pancrelipase) have been used for the treatment of patients with EPI due to cystic fibrosis and other conditions. Prior longer-term safety concerns seen with these products include: fibrosing colonopathy (a rare adverse event most commonly seen in children or when administering >2,500 lipase units/kg/meal (or >10,000 lipase units/kg/day) and hyperuricemia (due to the purines found in porcine-derived pancreatic enzyme products).
Dosing. The dosage of pancrelipase delayed-release capsules should be individualized based on clinical symptoms, the degree of steatorrhea present, and fat content of the patient's diet. Moreover, 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.
