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ZENPEP® and its design are registered trademarks of Aptalis Pharma Limited, an Allergan affiliate.
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ZEN42030
02/16
For U.S. audiences only.
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*Exocrine pancreatic insufficiency (EPI).
IMPORTANT RISK INFORMATION
What is the most important information I should know about ZENPEP?
- ZENPEP® (pancrelipase) 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 doctor gave you. Call your doctor right away if you have any unusual or severe: stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.
- Take ZENPEP exactly as prescribed. Do not take more or less ZENPEP than directed by your doctor.
Before you take ZENPEP, 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; are breastfeeding or plan to breastfeed.
- About all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
How should I take ZENPEP?
- Take ZENPEP exactly as your doctor tells you.
- Do not crush or chew the ZENPEP capsule 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. See Patient Medication Guide and talk to your doctor for additional directions.
Side Effects
- ZENPEP may cause serious side effects, including worsening of swollen, painful joints (gout) caused by an increase in blood uric acid levels and allergic reactions including trouble with breathing, skin rashes, or swollen lips. Call your doctor right away if you have any of these symptoms.
- The most common side effects of ZENPEP include belly pain, gas, and headache.
- 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.
- Tell your doctor if you have any side effect that bothers you or does not go away. These are
not all the possible side effects of ZENPEP.
For more information, ask your doctor or pharmacist.
What is ZENPEP?
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. ZENPEP contains a mixture of digestive enzymes (lipases, proteases, and amylases) from pig pancreas. ZENPEP is safe and effective in children.
Please also see Patient Medication Guide within the full Full Prescribing Information.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Fibrosing Colonopathy
- Fibrosing colonopathy is a rare serious adverse reaction associated with high-dose use of pancreatic enzyme replacement.
- Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
Potential for Irritation to Oral Mucosa
- To avoid irritation of oral mucosa, care should be taken to ensure the ZENPEP capsule or its contents are not crushed, chewed, or retained in the mouth. ZENPEP may be added to a small amount of acidic soft food.
Potential for Risk of Hyperuricemia
- Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia.
Potential Viral Exposure from the Product Source
- There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP; however, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Allergic Reactions
- Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase).
- Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
Adverse Reactions
- The most common adverse events (≥6% of patients treated with ZENPEP) were abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.
Additional Important Safety Information
- ZENPEP is not interchangeable with any other pancrelipase product.
- Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
INDICATIONS and USAGE
- ZENPEP® (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
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The health information described on this site is provided for educational purposes only and is not intended to substitute discussions with a healthcare provider.
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