Digestive Care, Inc.

Full Prescribing Information and Medication Guide
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Important Safety Information

PERTZYE may increase the risk of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gives you. Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stools (constipation), nausea, vomiting, or diarrhea.
Do not crush or chew the PERTZYE capsules or their contents and do not hold the capsule or capsule contents in your mouth. Always take Pertzye with a meal or snack and drink plenty of liquid to ensure complete swallowing of the PERTZYE capsules or PERTZYE capsule contents-food mixture. Take PERTZYE exactly as prescribed by your doctor. See the Instructions for Use at the end of the Medication Guide for detailed instructions about how to give PERTZYE by mouth and through a gastrostomy tube.
The most common side effects of PERTZYE include diarrhea, upset stomach (indigestion), and cough. Other potential serious side effects are irritation of the inside of your mouth; increase in blood uric acid levels (hyperuricemia); and severe allergic reactions, including trouble with breathing, skin rashes, swollen lips, or itching. Tell your doctor if you have any side effect that bothers you or that does not go away.
Tell your doctor if you are allergic to pork (pig) products, have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy), have gout, kidney disease, or high blood uric acid (hyperuricemia), have trouble swallowing capsules, have any other medical condition, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your doctor about all the medicines you take.
PERTZYE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Uses for PERTZYE Delayed-Release Capsules

PERTZYE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. PERTZYE capsules contain a mixture of digestive enzymes including lipases, proteases and amylases from pig pancreas. PERTZYE is safe and effective in adults and children.

Click here to read the Full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication (Healthcare Provider)

PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency (EPI) in adult and pediatric patients.

Important Safety Information

Fibrosing Colonopathy is associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.
Irritation of the Oral Mucosa may occur due to loss of protective enteric coating on the capsule contents. Do not crush or chew PERTZYE capsules or capsule contents.
Hyperuricemia has been reported with high dosages, consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.
The most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.
Do not substitute other pancreatic enzyme products for PERTZYE.

Please click here for Full Prescribing Information.

PERTZYE® is a registered trademark of Digestive Care, Inc.
PERTZYE® (pancrelipase) Delayed-Release Capsules are manufactured in the USA by Digestive Care, Inc.
©2024 Digestive Care, Inc. All rights reserved. Created in the USA. 23012 Rev 6 06/2024