Berotralstat
Drugs Used In Hereditary Angioedema
Sold as ORLADEYO
- Drug class
- Drugs Used In Hereditary Angioedema
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Berotralstat is an active pharmaceutical ingredient in the Drugs Used In Hereditary Angioedema group (B06AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 1 | March 10, 2026 |
| EU European Union | EMA | 1 | February 18, 2026 |
| GB United Kingdom | MHRA | 1 | June 23, 2021 |
CACanada· Health Canada
1 product
Uses
ORLADEYO (berotralstat) is indicated for the routine prevention of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.
Limitations of Use:
The safety and efficacy of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the 150 mg once daily dose are not recommended due to the potential for QT prolongation (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
1 Pediatrics Pediatrics (≥12 years and weighing ≥40 kg) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ORLADEYO in pediatric patients in this age and weight group has been established. Therefore, Health Canada has authorized an indication for pediatric use in patients ≥12 years of age (see 14 CLINICAL TRIALS).
EUEuropean Union· EMA
1 product
Uses
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
How to take
GBUnited Kingdom· MHRA
1 product
Drug interactions
Known interactions involving Berotralstat. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02527693 · revised March 10, 2026
- [2]European Medicines Agency · EMEA/H/C/005138 · revised February 18, 2026
- [3]MHRA (UK) · PL506800001 · revised June 23, 2021
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.