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INDICATIONS AND IMPORTANT
SAFETY INFORMATION

INDICATIONS AND USAGE

ZENPEP^® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Fibrosing Colonopathy

Fibrosing colonopathy is a rare serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis.
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 or 4,000 lipase units/g fat ingested/day).

Irritation of the Oral Mucosa

Crushing or chewing ZENPEP capsules or mixing the capsule contents in foods having a pH greater than 4.5 can cause irritation of the oral mucosa. Do not crush or chew capsules or capsule contents.

Hyperuricemia

Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia.

Risk of Viral Transmission

There is theoretical risk for transmission of viral disease. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Hypersensitivity Reactions

Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products.
Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with ZENPEP.

Adverse Reactions

The most common adverse reactions (≥6% of patients treated with ZENPEP) were headache, contusion, cough, and early satiety.

Additional Important Safety Information

Please see the full Prescribing Information for ZENPEP.

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ZP-PM-USA-0081 03/25

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