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Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).
Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.
To avoid irritation of oral mucosa, do not chew PANCREAZE or retain in the mouth.
There is theoretical risk of viral transmission with all pancreatic enzyme products including PANCREAZE.
Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
Most common adverse reactions (≥ 10%) are: abdominal pain, flatulence, diarrhea, abnormal feces, and fatigue.
PANCREAZE is not interchangeable with any other pancrelipase products.
Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
References: 1. VIVUS, Inc. PANCREAZE®: Highlights of prescribing information. 2010.