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Pertyze (Pancrelipase delayed-release capsules): A combination of porcine-derived lipases, proteases, and amylases for the treatment of exocrine pancreatic insufficiency (EPI)
New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
On May 18, 2012, FDA approved pancrelipase delayed-release capsules (Pertzye, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI ) due to cystic fibrosis or other conditions. Pertzye, which is a combination of porcine-derived lipases, proteases, and amylases, is the sixth pancrelipase product to be approved by FDA. It is not interchangeable with other pancrelipase products.
Efficacy. The short-term efficacy of pancrelipase delayed-release capsules was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 24 patients with EPI due to cystic fibrosis. Subjects received an individually titrated dose of pancrelipase delayed-release capsules (≤2,500 lipase units/kg/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 mean coefficient of fat absorption was 83% with pancrelipase delayed-release capsules compared to 46% with placebo (difference of 36%, 95% CI, 28%–45%; P<.001). The mean change in coefficient of nitrogen absorption also favored pancrelipase delayed-release capsules as compared to placebo (difference of 32%; P<.05).
Safety. The short-term safety of pancrelipase delayed-release capsules was assessed in the same crossover study. The most common adverse reactions (occurring in ≥10% of subjects) observed in the clinical trial were diarrhea, dyspepsia, and cough. Delayed- and immediate-release pancreatic enzyme products with the same active ingredient (pancrelipase) have been used for the treatment of patients with EPI due to cystic fibrosis and other conditions. Prior longer-term safety concerns seen with these products include: fibrosing colonopathy (a rare adverse event most commonly seen in children or when administering >2,500 lipase units/kg/meal (or >10,000 lipase units/kg/day) and hyperuricemia (due to the purines found in porcine-derived pancreatic enzyme products).
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
