FAQs

Common Questions

ZENPEP (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF), or other conditions.
Yes. In the pivotal trial, patients with EPI due to CF achieved a near normal (≥85%) mean coefficient of fat absorption (CFA) of 88.3% with ZENPEP vs 62.8% with placebo (primary endpoint).1,2
Signs and symptoms of maldigestion or malabsorption associated with EPI include steatorrhea, abdominal pain, bloating, flatulence, or weight loss. Symptoms include frequent, soft, watery, bulky, oily, foul-smelling stools, or diarrhea.23
In addition to the treatment of causative factors, there are 2 key goals for managing EPI - improving digestion and absorption of nutrients and relieving GI signs and symptoms of EPI. Management includes lifestyle and dietary modifications, vitamin and nutrient supplementation, and pancreatic enzyme therapy.3.4-7
No. Concomitant agents such as proton pump inhibitors (PPIs), H2-antagonists, or motility agents were excluded from the trails.2
Dosage
  • ZENPEP is not interchangeable with any other pancrelipase product.Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of ZENPEP should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
Infants (up to 12 months)
  • Infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding
  • Do not mix ZENPEP capsule contents directly into formula or breast milk prior to administration
Children Older than 12 Months and Younger than 4 Years
  • Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤ 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day
Children 4 Years and Older and Adults
  • Enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤ 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day
  • Usually half of the prescribed ZENPEP dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately 3 meals plus 2 or 3 snacks per day
Limitations on Dosing
  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines

For further information on dosing and administartion, please see ZENPEP full Prescribing Information.

In an open-label, uncontrolled trial (N=19) in patients aged 1 to 6 years with EPI due to CF, patients showed similar control of fat malabsorption (spot fecal fat testing) and symptoms of malabsorption with ZENPEP as with their previous enzyme. ZENPEP is not interchangeable with any other pancrelipase product.
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;8:405-417. 3. Bruno MJ, Haverkort EB, Tytgat GNJ, van Leeuwen DJ. Maldigestion associated with exocrine pancreatic insufficiency: implications of gastrointestinal physiology and properties of enzyme preparations for a cause-related and patient-tailored treatment. Am J Gastroenterol. 1995;90:1383-1393. 4. Al-Kaade S. Exocrine pancreatic insufficiency. Medscape website. http://emedicine.medscape.com/article/2121028- overview. Accessed March 16, 2017. 5. Hardt PD, Ewald N. Exocrine pancreatic insufficiency in diabetes mellitus: a complication of diabetic neuropathy or a different type of diabetes? Exp Diabetes Res. 2011;2011:1-7. 6. Domínguez-Muñoz JE. Pancreatic exocrine insufficiency: diagnosis and treatment. J Gastroenterol Hepatol. 2011;26(suppl 2):12-16. 7. Domínguez-Muñoz JE. Chronic pancreatitis and persistent steatorrhea: what is the correct dose of enzymes? Clin Gastroenterol Hepatol. 2011;9:541-546. 8. Sikkens ECM, Cahen DL, Kuipers EJ, Bruno MJ. Pancreatic enzyme replacement therapy in chronic pancreatitis. Best Pract Res Clin Gastroenterol. 2010;24:337-347.

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.