PANCREAZE (pancrelipase (amylase)

Following oral administration, the lipases, proteases, and amylases released from PANCREAZE are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of PANCREAZE are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.

Studies 1 and 2 were conducted in 57 adult and pediatric patients, aged 6 months to 17 years, with exocrine pancreatic insufficiency due to cystic fibrosis.

Study 1Study 1 was a randomized, double-blind, placebo-controlled study of 40 patients, ages 8 to 57 years. In this study, patients received PANCREAZE at individually titrated doses (not to exceed 2,500 lipase units/kg/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 o...

The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] The data described below reflect exposure to PANCREAZE in 57 adult and pediatric patie...

None. None.

Fibrosing Colonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) Irritation of the Oral Mucosa : May occur due to loss of protective enteric coating on the capsule co...