Safety Profile

A tolerability profile in clinical trials with children and adults with EPI due to CF1

Treatment-emergent adverse events (AEs) occurring in at least 2 ZENPEP-treated patients (Study 1)1

This table depicts treatment-emergent AEs in patients with EPI due to CF aged ≥7 years that occurred in at least 2 patients (≥6%) during treament and crossover treatment periods with ZENPEP in Study 1.1

  • In the randomized trial (ZENPEP Study 1), the most common AEs (≥6% of patients treated with ZENPEP) were abdominal pain, flatulence, headache, contusion, decreased weight, cough, and early satiety1
  • No patient discontinued ZENPEP due to an AE or laboratory abnormality in the clinical trials2
  • No drug-related serious AEs were observed in the clinical trials2
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.

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.