Zenpep® is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP may help your body use fats, proteins and sugars from food.
Important Safety Information
• ZENPEP may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having fibrosing colonopathy may be reduced by following the dosing instructions your healthcare professional gave you. Call your healthcare professional right away if you have any unusual or severe: stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting or diarrhea.
• Tell your doctor about all 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), are pregnant or plan to become pregnant, are breast-feeding or plan to breast-feed.
• Take ZENPEP exactly as prescribed, and no more than what your doctor recommended for you. Consult your medication guide for how to take ZENPEP if you have trouble swallowing capsules.
• Do not crush or chew the ZENPEP capsules or its contents, and do not hold the capsule or contents in your mouth. This may cause irritation in your mouth or change the way ZENPEP works in your body.
• ZENPEP 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.
• The most common side effects of ZENPEP include pain in your belly, gas, and headache.
• Refer to your medication guide and full prescribing information every time you refill your prescription because information may change. Tell your healthcare professional if you have any symptom or side effect that bothers you or that does not go away.
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. If you cannot afford your medication, contact: www.pparx.org or call 1-888-4PPA-NOW for assistance.
Adverse Reactions
The most common adverse events (>6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. The most serious adverse reactions reported with different pancreatic enzyme preparations of the same active ingredient (pancrelipase) include fibrosing colonopathy, hyperuricemia and allergic reactions.
