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

Improvements in fat and protein absorption

PERTZYE® (pancrelipase) significantly increased fat absorption1,2

Bar graph comparing fat absorption with PERTZYE (pancrelipase) vs placebo
  • Mean coefficient of fat absorption was 83% with PERTZYE vs 46% with placebo (P<0.001)1,2
  • 78% improvement in fat absorption compared with placebo1,2
  • Response to treatment was similar in children (n=10) and adults (n=11) for all efficacy end points1,2
  • Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day)

PERTZYE does not require the concomitant use of acid-suppressing drugs2

PERTZYE significantly increased protein absorption*1,2

Bar graph comparing nitrogen absorption with PERTZYE (pancrelipase) vs placebo
  • Mean coefficient of nitrogen absorption was 79% with PERTZYE vs 47% with placebo (P<0.001)1,2
  • 68% improvement in nitrogen absorption compared with placebo1,2
Study design

A randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the efficacy and safety of PERTZYE in 24 patients aged 8 to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis. Patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units/kg body weight per meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days.1,2 The efficacy analysis included a total of 21 patients who completed both double-blind treatment periods. The primary efficacy end point was the mean difference in coefficient of fat absorption between PERTZYE and placebo.1 Secondary end points were mean difference in coefficient of nitrogen absorption, stool frequency, and stool weight.1,2


*Protein absorption assessed by the coefficient of nitrogen absorption.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth.

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough.

Indication

PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Please click here for Full Prescribing Information and Medication Guide.



References: 1. Konstan MW, Accurso FJ, Nasr SZ, Ahrens RC, Graff GR. Efficacy and safety of a unique enteric-coated bicarbonate-buffered pancreatic enzyme replacement therapy in children and adults with cystic fibrosis. Clin Invest. 2013;3(8):723-729. 2. PERTZYE (pancrelipase) Prescribing Information. Digestive Care, Inc., Bethlehem, PA: July 2017.