Safety Profile

ZENPEP® safety profile in clinical trials with children and
adults with EPI due to CF1

TREATMENT-EMERGENT ADVERSE EVENTS (Study 1)1*

Treatment chart Treatment chart

The most commonly reported AEs in Study 1 (≥6% of patients treated with ZENPEP) were abdominal pain, flatulence, headache, contusion, decreased weight, cough, and early satiety.1,2

  • No patient discontinued ZENPEP due to an AE or laboratory abnormality
  • No drug-related serious AEs were observed

*The short-term safety of ZENPEP was assessed in 2 clinical trials. In Study 1, AEs were defined as occurring in at least 2 patients treated with ZENPEP (≥6%) during treatment and crossover treatment periods with ZENPEP. Study 2 was an open-label, uncontrolled, 14-day study of 19 patients, ages 1 to 6 years, with EPI due to CF. The most commonly reported AEs were gastrointestinal, including abdominal pain and steatorrhea, and were similar in type and frequency to those reported in the double-blind, placebo-controlled trial (Study 1).1

CF=cystic fibrosis; EPI=exocrine pancreatic insufficiency; PERT=pancreatic enzyme replacement therapy.

References: 1. ZENPEP. Package insert. Nestlé Health Science; 2020. 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. doi:10.1016/j.jcf.2009.07.006