Posted from: Monday, October 31, 2016 - 03:35 PM - Present

Infant-Specific Dose of Pertzye Approved

October 11, 2016 - The U.S. FDA approved Pertzye® (pancrelipase) in a 4,000 USP lipase units delayed-release capsule strength. Pertzye, manufactured by Digestive Care, Inc. and Chiesi USA is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The recommended dose for infants up to 12 months of age is 4,000 lipase units (one capsule) per 120mL of formula or per breast-feeding. Pertzye has been on the market since 2012 and is currently supplied as delayed-release capsules containing 8,000 USP lipase units and 16,000 USP lipase units. It is approved for use in patients of all ages; dosing varies depending on a patient’s weight and age.


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Last Updated Monday, October 21, 2019 - 10:54 AM.