Delayed-Release Pancreatic Enzyme Product Approved for G-Tube Administration
Digestive Care and Chiesi announced that the Food and Drug Administration (FDA) has approved a labeling update for Pertzye (pancrelipase) which is indicated for exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
The revised labeling now includes gastrostomy tube (G-tube) administration of the 4,000 USP lipase units capsule. Specifically for G-tube administration, the 4,000 lipase units capsule was created with smaller pancreatic enzyme microspheres to meet the requirements for its administration through a 14 french or larger G-tube.
The Pertzye labeling describes the required steps for administering the 4,000 lipase units capsule through the G-tube. Only the contents of the 4,000 lipase units capsule should be used for G-tube administration and no more than two capsules should be administered at a time.
This update marks the first approved G-tube administration of enteric-coated pancreatic enzyme microspheres through a G-tube, allowing physicians, dietitians, and patients with EPI who have G-tubes to determine the best route of administration of Pertzye.
The pancreatic enzymes contained in Pertzye catalyze the hydrolysis of fats to monoglyceride, glycerol, and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars (eg, maltose, maltotriose), mimicking the digestive enzmes physiologically secreted by the pancreas.
Pertzye is supplied as 4,000 USP delayed-release capsules in 100-count bottles; 8,000 USP delayed-release capsules in 100- and 250-count bottles; 16,000 USP delayed-release capsules in 100-count bottles; and 24,000 USP delayed-release capsules in 80- and 200-count bottles.
For more information call (877) 882-5950 or visit Pertzye.com.