About EPI in cystic fibrosis

What is cystic fibrosis?

Cystic Fibrosis or CF is an inherited genetic disease that mainly affects the lungs and digestive systems. CF causes the mucus that normally coats and protects the lungs and digestive system to become thick and sticky.

Did you know?
CF is a genetic disease that affects more than 30,000 people in the United States, including approximately 1 out of every 3,500 babies

How CF affects the lungs

  • The mucus causes coughing and trouble breathing. It often causes lung infections because microbes get stuck in the mucus. These infections can cause damage to the lungs that gets worse over time.

How CF affects the digestive system

  • The mucus can clog up an organ called the pancreas. The pancreas secretes substances that help digest food in the intestines. Without these substances, the body can’t break down food to be used as nutrients. When these substances can’t reach the intestines, it results in exocrine pancreatic insufficiency (EPI) .

Understanding exocrine pancreatic insufficiency or EPI

The problem in EPI is often thought to be the blockage of pancreatic ducts that secrete digestive substances called pancreatic enzymes .

  • Pancreatic enzymes help break down food into nutrients in the duodenum after the food has been partially digested in the stomach. The intestines then absorb the nutrients into the body where they are used as energy.

However, other substances that aid in digestion are also disrupted in EPI. Another important substance is bicarbonate .

  • Bicarbonate helps pancreatic enzymes work efficiently to digest food in the duodenum.

Without the digestive action of pancreatic enzymes and the aid of bicarbonate (as well as other digestive substances), people with EPI can’t get enough nutrition from the food they eat. As a result, they have trouble growing or maintaining a healthy weight. They may also have symptoms like gas, bloating, and having lots of bowel movements that seem to be oily.

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PERTZYE® (pancrelipase) works
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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 before you start taking PERTZYE. You should also read the insert that comes with each prescription refill because there may be new information.

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.

References available upon request.