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

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

Silhoutte of a young boy

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

Silhoutte of a adult male
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

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. Data on file. Digestive Care, Inc. 3. PERTZYE (pancrelipase) Prescribing Information. Digestive Care, Inc., Bethlehem, PA: July 2017. 4. Borowitz DS, Grand RJ, Durie PR. Consensus Committee. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. J Pediatr. 1995;127(5):681-684.