Indication

For the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. 

Important Safety Information

• Fibrosing colonopathy is a rare serious adverse reaction associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ZENPEP exceed 2500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day)
• To avoid irritation of oral mucosa or inactivation of enzymes, do not chew ZENPEP or retain in the mouth
• Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia
• There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP
• Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin
• The most common adverse events (≥6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion

    © 2012 Aptalis Pharma US, Inc., Birmingham, AL.     All rights reserved.     ZP085-1111