ULTRESA 13800
Pharmacological Class:
Pancreatic enzymes.
Active Ingredient(s):
Lipase 13800, protease 27600, amylase 27600; del-rel caps; e-c minitabs in caps.
Also:
ULTRESA 20700
Lipase 20700, protease 41400, amylase 41400; del-rel caps; e-c minitabs in caps.
ULTRESA 23000
Lipase 23000, protease 46000, amylase 46000; del-rel caps; e-c minitabs in caps.
Company
Aptalis Pharmaceutical Technologies
Indication(s):
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
Pharmacology:
Ultresa is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases. The pancreatic enzymes in Ultresa catalyze the hydrolysis of fats to monoglycerides, 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 efficacy and safety of Ultresa were assessed in two studies conducted in 40 patients with exocrine pancreatic insufficiency due to cystic fibrosis.
Study 1 was a double-blind, placebo-controlled, crossover study of 31 patients (ages 8–37) who were randomized to receive Ultresa (at a dose not to exceed 2,500 lipase units/kg per meal or snack) or matching placebo for 6–7 days of treatment followed by crossover to the alternate treatment for an additional 6–7 days. The mean dose during the controlled treatment periods was 6,270 lipase units/kg/day. All patients consumed a high-fat diet (2g of fat/kg of body weight/day) during the treatment periods. The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. Each patient’s CFA during placebo treatment was used as their no-treatment CFA value. Mean CFA was 89% with Ultresa compared to 56% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of Ultresa therapy with 95% CI: (25, 45) and p<0.0001.
Study 2 was an open-label study of 9 patients (ages 7–11) with exocrine pancreatic insufficiency due to cystic fibrosis. The final analysis population was limited to 7 patients who completed both the washout and treatment phases of the study. After a 15 day screening period on individually-titrated doses of Ultresa not to exceed 2,500 lipase units/kg/meal, patients entered a 7-day washout phase (no treatment) before returning to a 12-day treatment phase on the same individually-titrated dose of Ultresa. The mean daily dose of Ultresa during the treatment phase was 6,846 lipase units/kg/day. All patients consumed a high-fat diet (2g of fat/kg of body weight/day) during both the washout phase and treatment phase. The mean CFA was determined during the washout phase (no treatment) and during the Ultresa treatment phase. Mean CFA was 35% during the washout phase and was 83% during the Ultresa treatment phase.
Legal Classification:
Rx
Adults & Children:
See full labeling. 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. Do not crush or chew caps; swallow whole, or may open and sprinkle contents into small amount of acidic food (pH ≤4) and swallow mixture immediately. >12months–<4yrs (<14kg): not recommended. >12months–<4yrs (≥14kg): 1000 lipase units/kg per meal; ≥4yrs (<28kg): not recommended. ≥4yrs (≥28kg): 500 lipase units/kg per meal. Max: 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested/day.
Warnings/Precautions:
Not interchangeable with any other pancrelipase products. Fibrosing colonopathy (w. high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to mucosa. Pregnancy (Cat.C). Nursing mothers.
Adverse Reaction(s)
Headache, pharyngolaryngeal pain, epistaxis; fibrosing colonopathy, hyperuricemia, allergic reactions.
How Supplied:
Caps (13800, 20700)—100; 2300—100, 500
LAST UPDATED:
1/14/2013
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