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Medical Areas: Gastroenterology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Johnson & Johnson
Approval Status: Approved April of 2010
Treatment Area: exocrine pancreatic insufficiency
Pancreaze is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands, as well as other enzyme classes, including porcine-derived lipases, proteases, and amylases. The pancreatic enzymes in Pancreaze act like digestive enzymes physiologically secreted by the pancreas.
Pancreaze is specifically indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Pancreaze is supplied as a capsule for oral administration. The dosing of Pancreaze should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. The recommendations are as follows:
Infants (up to 12 months)
Infants may be given 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Do not mix Pancreaze 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 for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 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 for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.
The FDA approval of Pancreaze was based on two studies conducted in 57 subjects with exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
This randomized, double-blind, placebo-controlled study enrolled 40 subjects, ages 8 to 57 years. The subjects received Pancreaze at individually titrated doses (not to exceed 2,500 lipase units per kilogram per meal) for 14 days (open label period) followed by randomization to Pancreaze or matching placebo for 7 days of treatment (double-blind withdrawal period). Only patients with coefficient of fat absorption (CFA) >80% in the open label period were randomized to the double-blind withdrawal period. All subjects consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period. The primary efficacy endpoint was the change in CFA from the open label period to the end of the double-blind withdrawal period. The CFA was determined by a 72-hour stool collection period during both treatment period. At the end of the double-blind withdrawal period, the mean change in CFA from the open label period to the end of the double-blind withdrawal period was -2% with Pancreaze treatment compared to -34% with placebo treatment.
This randomized, investigator-blinded, dose-ranging study of 17 patients, ages 6
months to 30 months. All subjects were transitioned from their usual PEP treatment to Pancreaze at 375 lipase units per kilogram body weight per meal for a 6 day run-in period. Patients were then randomized to receive Pancreaze at one of four doses (375, 750, 1,125, and 1,500 lipase units per kilogram body weight per meal) for 5 days. The CFA was measured at the end of the run-in period and at the end of the randomized period. Overall, patients showed similar CFA at the end of the run-in period (mean Pancreaze dose of 1,600 lipase units per kilogram body weight per day) as at the end of the study across the four treatment arms. Change in CFA (%) Day 6 to Day 11: -2 , 1, -1, -2, respectively.
Adverse events associated with the use of Pancreaze may include, but are not limited to, the following:
- abdominal pain
- abdominal pain upper
- abnormal feces
Mechanism of Action
Pancreaze is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. The pancreatic enzymes in PANCREAZE catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clinical Therapeutics 2010 Jan;32(1):89-103
For additional information regarding Pancreaze or exocrine pancreatic insufficiency, please visit the Pancreaze web page.