What is "pancrelipase"

n. A mixture of porcine-derived pancreatic amylase, pancreatic lipase, and chymotrypsin, used in the treatment of some digestive disorders.

Pancrelipases are commercial mixtures of pig-derived pancreatic amylase (a hydrolase acting on starch), pancreatic lipase, and chymotrypsin (a protease). They are used to improve food digestion in people who do not have enough pancreatic enzymes due to chronic pancreatitis, cystic fibrosis or obstruction of the pancreatic duct. The three components in the product are digestive enzymes akin to those normally produced by the human pancreas. Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006 FDA requirement that pharmaceutical companies with porcine-derived PERP products submit an NDA for each; Creon® (AbbVie Inc.) was the first of the commercial PERP products approved after the FDA directive, reaching market in 2009.

Pancrelipases are generally a first line approach in treatment of exocrine pancreatic insufficiency and other digestive disorders, accompanying cystic fibrosis, complicating surgical pancreatectomy, or resulting from chronic pancreatitis (see above). The formulations are generally hard capsules filled with gastro-resistant granules. Pancrelipases are similar to pancreatins, but with an increased lipase component.

The specific requirement and reasoning for the FDA directive was that manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide to ensure patients were adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theoretical risk of transmission of viral disease from pigs to patients", the risk of which (alongside other off-target effects) is reduced by patient adherence to label dosing instructions.