The US FDA has approved pancrealipase delayed-release capsules (Pertzye, Digestive Care Inc) for the treatment of children and adults with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF) or other conditions.
The unique pancreatic enzyme product contains bicarbonate-buffered enteric-coated microspheres and is protected by several US and international patents.
It has been marketed by the company under the trade name Pancrecarb MS-16 since 2004. This is the sixth such product for patients with CF.
Ultresa, Aptalis Pharma US Inc;
Viokace, Confab Laboratories Inc;
Creon (Abbot Labs);
Zenpep (Eurand SPA);
Pancreaze (Ortho-McNeil-Janssen Pharmaceuticals Inc).
This approval was based on data from a small, randomized, double-blind study of 21 patients aged 8 to 43 years (mean, 20 years) who were randomly assigned to receive the study drug at individually titrated doses or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days.
No differences were found between children and adults with respect to the severity of pancreatic insufficiency or response to the study medication.
The most commonly observed adverse events were diarrhea, dyspepsia, and cough (10% vs 4% for those receiving placebo, for each event).
Children aged from 1 to less than 4 years and weighing 8 kg or more should begin with a dose of 1000 lipase units/kg body weight per meal (maximum, 2500 units or ≤10,000 units/kg/day) or less than 4000 lipase units/g fat ingested daily.
Because ingestion of larger amounts is linked to a risk for fibrosing colonopathy, the FDA warns patients to contact their clinician immediately if they have unusual or severe abdominal pain, bloating, and trouble passing stool, nausea, vomiting, or diarrhea.
Capsules should be taken whole to avoid irritation of the oral mucosa, but contents may be mixed with applesauce for infants and others having difficulty swallowing.
Treatment is associated with a risk for hyperuricemia, so uric acid level monitoring should be considered in patients with gout or renal impairment. Caution is advised when prescribing pancrealipase delayed-release capsules for patients with a known allergy to proteins of porcine origin.
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