This site is intended for US healthcare professionals only.

For the treatment of exocrine pancreatic
insufficiency (EPI) due to cystic fibrosis (CF)
Mean dosage in a pivotal trial

Mean dosage of PERTZYE® (pancrelipase) was <1,600 USP lipase units/kg body weight per meal1

Pediatric subpopulation

 

Mean age: 12 years old

Mean weight: 40 kg (88 lb)

Mean dose:
1,593 USP lipase units/kg
body weight per meal2

Adult subpopulation

 

Mean age: 27 years old

Mean weight: 59 kg (130 lb)

Mean dose:
1,538 USP lipase units/kg
body weight per meal2

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. 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.1,3

Cystic Fibrosis Foundation Consensus Conferences recommendations for enzyme dosing4

AGE 0–12 months 1-4 years 4 years and older
RECOMMENDED
DOSING
4,000 USP lipase units
per 120 mL of formula
or per breastfeeding
1,000–2,500 USP
lipase units
per kg
body weight per meal
500–2,500 USP
lipase units
per kg
body weight per meal
“Patients currently on higher doses (>2,500 USP lipase units/kg body weight per meal or >4,000 USP lipase units/g fat ingested per day) should be evaluated and either immediately decreased, or titrated down to a lower dosage range.”4