What is PERTZYE® (pancrelipase) DELAYED-RELEASE CAPSULES

• PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency (EPI) 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.

For more information, visit www.pertzye.com.


How does PERTZYE® (pancrelipase) Work?

See how PERTZYE works.

 



How to Take PERTZYE® (pancrelipase)

• 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.
• PERTZYE 4,000 lipase units capsule contents may be given through a gastrostomy tube. Click here or on the form to download a PDF of the Pertzye gastrostomy tube instructions.
• Take PERTZYE exactly as your doctor tells you.
• You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor.
• Do not 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 dose.
• Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
• 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. Crushing, chewing or holding the PERTZYE capsules in your mouth may cause irritation in your mouth or change the way PERTZYE works in your body.
• If you miss a dose of PERTZYE, wait until your next meal or snack and take your prescribed dose. Take your next dose at your usual time. Do not take two doses at one time.


IMPORTANT SAFETY INFORMATION

PERTZYE may increase the risk 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 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.

The most common side effects of PERTZYE include diarrhea, upset stomach (indigestion), and cough. Other possible side effects of PERTZYE 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.

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.

Please click here to read the full Prescribing Information and Medication Guide.