Rx Product News Profile: A Closer Look at New FDA Actions: Eurand's Zenpep

Eurand Pharmaceuticals' Zenpep (pancrelipase) Delayed-Release Capsules have been approved by the FDA for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Eurand Pharmaceuticals’ Zenpep

The FDA has approved Eurand Pharmaceuticals’ Zenpep (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Zenpep is approved for use in both children and adults.

EPI occurs when the pancreas fails to manufacture an adequate amount of enzymes to digest food. It can be caused by disease such as CF, pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis. Complications of EPI include malnutrition, impaired growth in children, compromised immune response, and shortened life expectancy. It is estimated that 200,000 people in the United States are affected by EPI, and 30,000 people are affected by CF.¹

Zenpep cannot be interchanged with any other pancrelipase product.²

Mechanism of Action

Zenpep consists of porcine-derived pancreatic enzymes that catalyze the hydrolysis of fats to monoglycerol, glycerol, and fatty acids; protein into peptides and amino acids; and starch into dextrins and short chain sugars, thus exerting actions similar to those of the endogenous digestive enzymes that would normally be secreted by the pancreas.² Clinical Trials Zenpep was evaluated in 2 phase 3 multicenter clinical trials. A placebo-controlled, randomized, double-blind study included patients aged 8 to 23 with a primary efficacy end point of the mean coefficient of fat absorption (CFA). The CFA was found to be statistically higher in the Zenpep group than in the placebo group.

The other trial was an open-label, single-arm study that included children aged 1 through 6. Study participants switched from their regular pancreatic enzyme product to a comparable dose of Zenpep and still maintained symptom control. The overall safety and efficacy of Zenpep in this younger population was found to be similar to that of the older patients in the other trial.¹

Dosing

Zenpep is intended for oral administration only. Dosing should begin with the lowest recommended dose and increase gradually based on clinical symptoms, steatorrhea, and dietary fat content.

• Infants up to 12 months of age may be given 2000 to 4000 lipase units per 120 mL of formula or per breast-feeding. The contents should not be mixed into formula or breast milk, as this may result in a decrease in efficacy. The capsule may be opened and mixed into an acidic food with a pH of 4.5 or less, such as commercially prepared applesauce, bananas, or pears.

• Children over 12 months and under 4 years: 1000 to 2500 lipase units/kg of body weight per meal. Total daily dose should remain ≤10,000 lipase units/kg or <4000 lipase units/g of fat ingested.

• Children over 4 years and adults: 500 to 2500 lipase units/kg per meal. Total daily dose should remain ≤10,000 lipase units/kg or <4000 lipase units/g of fat ingested. Half of the meal dose should be given with each snack.²

Contraindications, Warnings, Precautions, and Adverse Reactions

There are no contraindications to the use of Zenpep.

High doses of pancreatic enzyme replacement have been associated with fibrosing colonopathy; caution should be used with Zenpep doses over 2500 lipase units/kg per meal or over 10,000 lipase units per day. Zenpep should be swallowed whole and immediately; it should not be chewed or retained in the mouth, as it may cause irritation to the oral mucosa. Porcine-derived enzyme products may increase blood uric acid levels; caution should be used when prescribed to patients with gout, renal impairment, or hyperuricemia. All pancreatic enzyme products, including Zenpep, present a theoretical risk for viral transmission. Use caution when administering Zenpep to patients with a known allergy to porcine proteins.

Zenpep is pregnancy category C. It is not known if Zenpep is excreted into breast milk.

In clinical trials, the most common adverse reactions were abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.² â– 

Dr. Holmberg is the pharmacy coordinator at Desert Vista Behavioral Health Center in Mesa, Arizona.

References

1.

Eurand Launches Zenpep (Pancrelipase) Delayed-Release Capsules. Available at http://ir.eurand.com/releasedetail.cfm?ReleaseID=426857. Accessed February 2010

2. Zenpep complete prescribing information. Available at http://www.zenpep.com/pdfs/zenpep_PI_09.pdf. Accessed February 2010.