General Information

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.

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.

Side Effects

Adverse events associated with the use of Pancreaze may include, but are not limited to, the following:

• Abdominal pain
• Abdominal pain upper
• Flatulence
• Diarrhea
• Abnormal feces
• Fatigue

Dosing/Administration

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 younger 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.

Clinical Trial Results

FDA Approval
The FDA approval of Pancreaze was based on two studies conducted in 57 subjects with exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
 

Study One
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 seven days of treatment (double-blind withdrawal period). Only patients with coefficient of fat absorption (CFA) >80 percent 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 end point 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 periods. 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 percent with Pancreaze treatment compared to -34 percent with placebo treatment.
 

Study Two
This randomized, investigator-blinded, dose-ranging study consisted 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 six-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 five 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 (percent) Day 6 to Day 11: -2 , 1, -1 and -2, respectively.