ORLADEYO™ (berotralstat) has established safety

The safety of ORLADEYO was established in the first clinical study

  • The most common side effects that occurred in people taking ORLADEYO and more frequently than in those taking placebo were abdominal pain, vomiting, diarrhea, back pain, and heartburn
  • In people taking ORLADEYO, gastrointestinal (GI) events (including abdominal pain, vomiting, and diarrhea) generally occurred early after starting treatment, became less frequent with time, and typically got better on their own
    • If you experience GI side effects that don’t go away, your doctor may prescribe a reduced dosage of ORLADEYO 110 mg once daily with food

What to avoid when taking ORLADEYO

  • It is not known if ORLADEYO is safe and effective to treat an acute HAE attack, therefore ORLADEYO should not be used to treat an acute HAE attack
  • Do not take additional doses of ORLADEYO to treat an acute swelling attack
  • Do not take more than 1 capsule of ORLADEYO per day because extra doses can cause heart rhythm problems. If you do, call your healthcare provider right away
  • Do not start taking ORLADEYO without telling your healthcare provider about all the medicines you take. Taking ORLADEYO with certain other medicines may affect the way those medicines work and other medicines may affect how ORLADEYO works

Talk to your healthcare provider if you experience any side effects.