berotralstat dihydrochloride at a glance
Medicine class
Plasma kallikrein inhibitor
Main role
Routine prevention of recurrent HAE attacks
How it is taken
Swallow the capsule with food and a glass of water.
Important limitation
Keep prescribed rescue treatment available because berotralstat does not treat acute HAE attacks.
What is berotralstat dihydrochloride used for?
This product is licensed for:
Routine prevention of recurrent hereditary angioedema attacks in adults and adolescents aged 12 years and over.
How does berotralstat dihydrochloride work?
In HAE caused by deficient or poorly functioning C1 inhibitor, uncontrolled plasma kallikrein can release excess bradykinin, making blood vessels leak fluid into tissues. Berotralstat inhibits plasma kallikrein, reducing this pathway and helping prevent swelling attacks.
berotralstat dihydrochloride preparations and strengths
Capsule
Route: Oral
Strengths: 150 mg
How to take berotralstat dihydrochloride
The capsule is taken by mouth with food, which helps reduce gastrointestinal effects.
Swallow the capsule with a glass of water.
berotralstat dihydrochloride side effects
Common or expected effects
- Headache
- Abdominal pain or discomfort
- Diarrhoea or frequent bowel movements
- Vomiting, nausea, heartburn or wind
- Rash
- Raised ALT or AST liver enzymes on blood tests
berotralstat dihydrochloride in pregnancy
Human pregnancy information is limited, and berotralstat is not recommended during pregnancy. Discuss pregnancy, pregnancy plans and effective contraception with the specialist team.
berotralstat dihydrochloride while breastfeeding
It is unknown whether berotralstat enters human milk, and a risk to a breastfed child cannot be excluded. Continuing breastfeeding or treatment requires an individual benefit–risk discussion with the specialist.
berotralstat dihydrochloride interactions
Check prescribed, over-the-counter and herbal products with the specialist or pharmacist. Important examples include:
Rifampicin and St John’s wort
These induce P-gp and BCRP and may lower berotralstat exposure, reducing its preventive effect; combined use is not recommended.
CYP3A4 substrates such as fentanyl, ciclosporin, amlodipine and midazolam
Berotralstat can increase their concentrations, so medicine-specific review, monitoring or adjustment may be needed.
CYP2D6 substrates such as tricyclic antidepressants, pimozide and thioridazine
Exposure may increase, particularly for medicines with a narrow therapeutic range or monitoring requirements.
Common questions about berotralstat dihydrochloride
Answers are fully visible for fast scanning and source review.
Is berotralstat dihydrochloride the same as Orladeyo?
Berotralstat is the active substance; Orladeyo is the brand name of the capsule product.
Can it stop an HAE attack that has already started?
No. It is preventive treatment, not rescue treatment. Follow the prescribed acute-treatment plan for a breakthrough attack.
Can HAE attacks still happen during treatment?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.