Digestive Care, Inc. Announces FDA Labeling Revision Approval for PERTZYE® (pancrelipase) Administering PERTZYE® through a gastrostomy tube
Revision Includes Administration Via G-Tube of the 4,000 USP Lipase Units Dosage of Delayed-Release Capsules to Treat Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis (CF) and Other Conditions
BETHLEHEM, Pa., (Marketwired — July 12, 2017) — Digestive Care, Inc. (DCI) and its marketing partner to support the U.S. cystic fibrosis (CF) community, Chiesi, today announced U.S. Food and Drug Administration (FDA) approval of a labeling revision to now include gastrostomy tube (G-tube) administration of the 4,000 USP lipase units capsule of PERTZYE® (pancrelipase), for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
To support administration via G-tube, the previously approved pediatric dosage of PERTZYE in a 4,000 lipase units capsule was developed featuring pancreatic enzyme microspheres of reduced size to meet the requirements necessary to administer them through a 14 french or larger G-tube. Today's FDA labeling revision approval is a milestone achievement in the development process of PERTZYE.
"We are pleased to offer the first FDA approved G-tube administration of enteric-coated pancreatic enzyme microspheres through a gastrostomy tube. This will allow physicians and dieticians to work together with EPI patients who have G-tubes and their caregivers to determine which method of administration of PERTZYE is most appropriate," said Tibor Sipos, Ph.D., President and Chief Scientific Officer, Digestive Care, Inc. "EPI is a complex condition for caregivers to manage, especially for infants and children who require tailored dosing and specialized administration."
The procedure required for effective administration of the 4,000 lipase units capsule of PERTZYE through a G-tube is now available in the FDA approved PERTZYE Prescribing Information and Patient Labeling (medication guide and instructions for use).
"Digestive Care, Inc. and Chiesi are committed to delivering therapeutic treatment options that meet the unique health needs of CF patients," said Alan Roberts, Senior Vice President of Scientific Affairs at Chiesi. "We continue to support patients and caregivers alike, through exploring treatment options that bring innovative solutions to CF patients and our various touch points within the CF community."
In addition, Chiesi serves CF patients' unique health needs with the Chiesi CareDirect program, a comprehensive patient program that can provide patients with prescription access, financial assistance, 1-on-1 support and much more. For more information, please visit www.pertzyecf.com/savings-support/chiesi-caredirect/.
ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES
PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
IMPORTANT SAFETY INFORMATION
Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).
To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth. Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.
There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.
Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
Most common adverse reactions (≥10%) are: diarrhea, dyspepsia, and cough.
PERTZYE® full Prescribing Information and Medication Guide are available at www.pertzyecf.com.
PERTZYE® (pancrelipase) is owned by Digestive Care, Inc. and is licensed to Chiesi USA for sales and marketing purposes in the United States.
About Digestive Care, Inc.
Digestive Care, Inc., headquartered in Bethlehem, PA, is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. For more information, visit www.digestivecare.com.
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Chiesi USA, Inc.
Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.chiesiusa.com.
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