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.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.