Efficacy

Help fuel your patients' nutritional health with significant improvement in CFA vs placebo1

For the treatment of EPI due to CF or other conditions ZENPEP helps fuel nutritional health, increasing coefficient of fat absorption (CFA) by 26 percentage points vs placebo1

Primary Endpoint: Mean difference in CFA1,2*

*A randomized, double-blind, placebo-controlled, 2-treatment, crossover study (ZENPEP Study 1) in patients with EPI due to CF aged 7 to 23 years. Patients were randomized to ZENPEP or placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for 6 to 7 days. All patients consumed ≥ 100 g fat per day. The primary efficacy endpoint was the mean difference in CFA between ZENPEP and placebo, which was measured from a 72-hour stool collection during both treatments. The use of enzymes other than ZENPEP and drugs affecting gastric pH or motility were not allowed during the trial.1,2
One patient did not have fecal fat and nitrogen readings while on placebo.2

In a non-inferiority study, ZENPEP was shown to have comparable efficacy to Creon®3

ZENPEP demonstrated both non-inferiority and equivalence to Creon in dietary fat absorption (ZENPEP 84.1% vs Creon 85.3%; difference in LS means: –1.3% [95% CI, –3.6 to 1.1] P=0.297)

A randomized, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged ≥12 years. Patients enrolled with an established PEP regimen and then a 100 g (± 15 g) fat/day diet was assigned and maintained throughout the study. Patients were randomized to 2 treatment sequences of 28 days each: ZENPEP/Creon or Creon/ZENPEP. The primary efficacy endpoint was CFA over 72 hours (CFA-72 hours).3

ZENPEP significantly improved CFA in patients with EPI due to CF2

  • In clinical trials, patients did not use agents that affect gastric motility or stomach pH

PPIs, H2 blockers, motility agents, buffering agents, laxatives, agents for gastric ulcers, and synthetic fat substitutes or fat-blocking nutritional supplements

EPI=exocrine pancreatic insufficiency; CF=cystic fibrosis; CFA=coefficient of fat absorption; PEP=pancreatic enzyme product; PPI=proton pump inhibitor.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Fibrosing Colonopathy
  • Fibrosing colonopathy is a rare serious adverse reaction associated with high-dose use of pancreatic enzyme replacement.
  • Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
Potential for Irritation to Oral Mucosa
  • To avoid irritation of oral mucosa, care should be taken to ensure the ZENPEP capsule or its contents are not crushed, chewed, or retained in the mouth. ZENPEP may be added to a small amount of acidic soft food.
Potential for Risk of Hyperuricemia
  • Exercise caution when prescribing ZENPEP to patients with gout, renal impairment or hyperuricemia.
Potential Viral Exposure from the Product Source
  • There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP; however, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Allergic Reactions
  • Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase).
  • Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
 Adverse Reactions
  • The most common adverse events (≥6% of patients treated with ZENPEP) were abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.
Additional Important Safety Information
  • ZENPEP is not interchangeable with any other pancrelipase product.
  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
INDICATIONS AND USAGE

ZENPEP® (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.

References

1. ZENPEP [package insert]. Irvine, CA: Allergan USA, Inc.; March 2017. 2. Wooldridge JL, Heubi JE, Amaro-Galvez R, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009;8(6):405-417. 3. Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016;15(5):675-680. 4. Data on file. Aptalis Pharma US, Inc.

IMPORTANT SAFETY INFORMATION and INDICATION More Less
Warnings and Precautions
Fibrosing Colonopathy
  • Fibrosing colonopathy is a rare serious adverse reaction associated with high-dose use of pancreatic enzyme replacement.
  • Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
Potential for Irritation to Oral Mucosa
  • To avoid irritation of oral mucosa, care should be taken to ensure the ZENPEP capsule or its contents are not crushed, chewed, or retained in the mouth. ZENPEP may be added to a small amount of acidic soft food.
Potential for Risk of Hyperuricemia
  • Exercise caution when prescribing ZENPEP to patients with gout, renal impairment or hyperuricemia.
Potential Viral Exposure from the Product Source
  • There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP; however, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Allergic Reactions
  • Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase).
  • Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
 Adverse Reactions
  • The most common adverse events (≥6% of patients treated with ZENPEP) were abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.
Additional Important Safety Information
  • ZENPEP is not interchangeable with any other pancrelipase product.
  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
INDICATIONS AND USAGE

ZENPEP® (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.