Safety

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

TREATMENT-EMERGENT ADVERSE EVENTS (Study 1)1*

Table showing the most common adverse events in Study 1: abdominal pain, flatulence, headache, contusion, weight decreased, cough, and early satiety.Table showing the most common adverse events in Study 1: abdominal pain, flatulence, headache, contusion, weight decreased, cough, and early satiety.

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

CF=cystic fibrosis; EPI=exocrine pancreatic insufficiency.

* 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 adverse events 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

References: 1. ZENPEP. Package insert. Aimmune Therapeutics, Inc. Bridgewater, NJ; October 2023. 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