Berotralstat
Brand names: Orladeyo
Berotralstat is an oral plasma kallikrein inhibitor used for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
It selectively inhibits plasma kallikrein, reducing the generation of bradykinin, the mediator responsible for the increased vascular permeability and swelling of hereditary angioedema attacks.
Prescribing in practice
- It is a prophylactic agent and does not treat acute attacks, so patients must retain access to a separate on-demand treatment for breakthrough episodes.
- It can prolong the QT interval at higher exposures and inhibits certain CYP enzymes, so review concomitant drugs for interactions and QT effects.
- Use is restricted to prevention of recurrent attacks and should follow specialist assessment of attack frequency and severity.
Monitoring
Monitor attack frequency and severity to assess response, and consider ECG monitoring where there is additional risk of QT prolongation or interacting drugs.
Counselling the patient
- This medicine is taken regularly to prevent attacks, not to treat one that has already started.
- Keep using your separate rescue treatment for any acute attack.
- Tell your clinician about all other medicines you take, including new ones.
Evidence & guidelines
NICE has appraised berotralstat for preventing recurrent attacks of hereditary angioedema, supported by the APeX-2 trial.
Reference: NICE TA738; UK PIN HAE; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
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