PERTZYE 8000 Rx

Indication(s):

Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Pharmacology:

Pertzye is a pancreatic enzyme preparation for oral administration consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. The pancreatic enzymes in Pertzye catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Clinical Trials:

The short-term safety and efficacy of Pertzye were evaluated in a randomized, double-blind, placebo-controlled, crossover study conducted in 24 patients ages 8–43 years (mean age = 20 years) with exocrine pancreatic insufficiency due to cystic fibrosis. The efficacy analysis population included 21 patients who completed both double-blind treatment periods. Patients were randomized to receive Pertzye at individually titrated doses (not to exceed 2500 lipase units per kilogram per meal) or matching placebo for 6–8 days of treatment, followed by crossover to the alternate treatment for an additional 6–8 days.

The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between Pertzye and placebo treatment. The CFA was determined by a 72 hour stool collection during both treatments, when both fat ingestion and excretion were measured. Mean CFA was 83% with Pertzye treatment compared to 46% with placebo treatment. The mean difference in CFA was 36 percentage points in favor of Pertzye treatment with 95% CI: (28, 45) and P<0.001.

The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient’s CNA during placebo treatment was used as their no-treatment CNA value. Mean CNA was 79% with Pertzye treatment compared to 47% with placebo treatment. The mean difference in CNA was 32 percentage points in favor of Pertzye treatment and this was a statistically significant change.

Legal Classification:

Rx

Adults & Children:

See literature. Start at the lowest recommended dose and increase gradually. Individualize based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Swallow whole; do not crush or chew caps. May mix contents with applesauce or other acidic soft food (pH≤ 4.5); swallow mixture immediately, follow with water or juice; take with meals; do not let any drug remain in mouth. 12mos–<4yrs and ≥8kg: initially 1000 lipase units/kg per meal. ≥4yrs and ≥16kg: initially 500 lipase units/kg per meal. Both: max 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested per day.

Warnings/Precautions:

Not interchangeable with other pancrelipase products. Fibrosing colonopathy (with high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia; consider monitoring uric acid levels. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s)

Diarrhea, dyspepsia, cough; allergic reactions.

How Supplied:

Caps—100, 250

LAST UPDATED:

12/17/2012