PANCREAZE is a combination of porcine-derived lipases, proteases, amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Efficacy

PANCREAZE is proven to improve fat and protein absorption7

PANCREAZE is a prescription medication that treats Exocrine Pancreatic Insufficiency (EPI) — a condition characterized by deficiency of the exocrine pancreatic enzymes (lipase, protease and amylase), resulting in maldigestion of food.8

In clinical studies, PANCREAZE significantly improved fat absorption vs. placebo and also improved nitrogen absorption, a surrogate marker of protein absorption.7

Mean CFA and CNA Improvements (%)

Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001). Improvement of Fat Absorption (CFA)*. Mean difference in CFA was approximately 30% (P<0.001). Improvement of Nitrogen Absorption (CNA)*. Mean difference in CNA was approximately 24% (P<0.001).

See Study Design

PANCREAZE is proven to improve EPI symptoms7

(i.e.: abdominal pain, bloating, diarrhea, greasy stools) vs. placebo

EPI SYMPTOMS Placebo (N=20) PANCREAZE (N=20)
Any 11 (55%) 4 (20%)
Abdominal pain 6 (30%) 3 (15%)
Bloating 3 (15%) 1 (5%)
Diarrhea 4 (20%) 0 (0%)
Greasy stools 3 (15%) 0 (0%)
Vomiting 0 (0%) 1 (5%)

Study design

  • Randomized, double-blind, placebo-controlled study of 40 patients, ages 8 to 57 years, with EPI due to CF.
  • The study consisted of a 7-day screening phase, 14-day open-label run-in phase, and 7-day placebo controlled, double-blind, withdrawal phase. The duration of the double-blind phase ranged from 4 to 7 days, depending on patients’ gastrointestinal transit time. During the double-blind phase, participants with a CFA 80% were randomized (1:1) to continue their optimized dose of PANCREAZE (10.5 or 21) or switched to placebo.
  • The primary efficacy endpoint was change in percent CFA between the 72-hour stool collections at the end of the open- label phase and double-blind phase. A key secondary variable was change in coefficient of nitrogen absorption (CNA), a surrogate for protein absorption, from the open-label phase to the double-blind phase. Another key secondary variable was prevention of the clinical signs and symptoms of EPI (abdominal pain, bloating, diarrhea, greasy stools, vomiting) during the double-blind phase.
 

Primary and key secondary efficacy assessments of the study participants7

Primary and key secondary efficacy assessments of the study participants chart. Primary and key secondary efficacy assessments of the study participants chart.

CFA: coefficient of fat absorption; CNA: coefficient of nitrogen absorption. Intent-to-treat analyses set with 20 participants in Placebo (12 adults; 8 children), and 20 in PANCREAZE (14 adults; 6 children); The change in CFA and CNA from open-label to double-blind was analyzed using an analysis-of-covariance model with treatment as a factor and baseline values as covariates.

 

Healthcare Professional Resource Center

  • Order samples, request materials, or a rep call
  • Download product information and patient materials

Indication

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

To avoid irritation of oral mucosa, do not chew PANCREAZE or retain in the mouth.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PANCREAZE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Most common adverse reactions are: abdominal pain, flatulence, diarrhea, abnormal feces, and fatigue.

PANCREAZE is not interchangeable with any other pancrelipase products.

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

Please read the PANCREAZE Medication Guide and PANCREAZE Product Information.

References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2020. 2. CREON® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2015. 3. PERTZYE® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2017. 4. ULTRESA® Full Prescribing Information. Bridgewater, NJ: Aptalis Pharma US, Inc; 2011. 5. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 6. ZENPEP® Full Prescribing Information. Irvine, CA: Allergan USA, Inc; 2017. 7. Trapnell BC, et al. Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2011;10(5):350-35 6. 8. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI), Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 9. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):2 9. 10. Fiekere A, et al. Enzymatic replacement therapy for pancreatic insufficiency: present and future. Clin Exper Gastroenterol. 2011;4:55- 73. 11. Ferrone MF, et al. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-9 20. 12. Keller J and Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(Suppl VI):v i1-vi 28. 13. Van der Haak N, Kench A. Chapter 10: pancreatic enzyme replacement therapy. In: Saxby N, King S, Kench A. Nutrition Guidelines for Cystic Fibrosis in Australia and New Zealand Administration Report. 2018.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

VIEW ALL +