Digestive Care, Inc.

Full Prescribing Information and Medication Guide
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Contact for Health Care Providers:

PHONE: xxx-xxx-xxxx

EMAIL: HealthCare@pertzye.com

Important Safety Information

PERTZYE® (pancrelipase) may increase the risk of having a rare bowel disorder called fibrosing colonopathy, especially if taken at a high dose in children with cystic fibrosis who are less than 12 years of age. This condition is serious and may require surgery. The risk of having fibrosing colonopathy 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.

Take PERTZYE capsules exactly as your doctor tells you. You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor. Don’t take more capsules in a day than the number your doctor tells you to take (total daily dose). Always take PERTZYE with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily enzyme dose. PERTZYE capsules should be swallowed whole. Do not crush or chew the PERTZYE capsules or their contents, and do not hold the capsule or capsule contents in your mouth. Read the Medication Guide for instructions on how to take PERTZYE if you have trouble swallowing capsules.

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, which may cause worsening of swollen, painful joints (gout); and allergic reactions, including trouble swallowing or breathing, skin rash, itching, or swelling of your face, eyes, lips, tongue, or throat. Call your doctor right away if you have any of these symptoms.

Tell your doctor about all of your medical conditions, including 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, 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 can’t digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

PERTZYE capsules contain a mixture of digestive enzymes, including lipases, proteases, and amylases, from pig pancreas. PERTZYE is safe and effective in children and adults when taken as prescribed by your doctor.

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) 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.

The most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.

Please click here for Full Prescribing Information and Medication Guide.

PERTZYE® is a registered trademark of Digestive Care, Inc.
PERTZYE® (pancrelipase) Delayed-Release Capsules are manufactured in the USA by Digestive Care, Inc.
©2023 Digestive Care, Inc. All rights reserved. Created in the USA. 23012 Rev 5 11/2023