The safety of ORLADEYOTM (berotralstat) is supported
by data from patients across 2 clinical studies1

In APeX-2 (part 1), the most commona treatment-emergent adverse reactions were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease (GERD)1

ORLADEYO™ APeX-2 study adverse reaction summary ORLADEYO™ APeX-2 study adverse reaction summary

a≥10% and higher than placebo.1
bIncludes abdominal pain, abdominal discomfort, abdominal tenderness, and upper abdominal pain.1
cIncludes diarrhea and frequent bowel movements.1

Gastrointestinal (GI) adverse reactions generally occurred early after initiation of treatment, became less frequent with time, and typically self-resolved1

  • No patients in the ORLADEYO 150 mg dose group and 1 patient in the ORLADEYO 110 mg dose group discontinued treatment due to a GI adverse reaction in APeX-2 part 11
  • If GI reactions persist, a reduced dosage of 110 mg once daily with food may be considered1

Findings from the open-label, long-term safety study, APeX-S (interim
safety population, n=227), support the data observed in APeX-2 (part 1).1,2