This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Berotralstat oral

Updated 2 Feb 2023 | Hereditary angioedema


Oral formulations of berotralstat.

Drugs List

  • berotralstat 150mg capsules
  • ORLADEYO 150mg capsules
  • Therapeutic Indications


    Hereditary angioedema: prophylaxis

    Indicated for the prevention of recurrent attacks of hereditary angioedema in adult and adolescent patients aged 12 years and older.



    Weight 40kg and above: 150mg once daily.


    Children aged 12 years and above
    Weight 40kg and above: 150mg once daily.

    Additional Dosage Information

    A missed dose should be taken as soon as possible without exceeding the recommended one dose per day.


    Children under 12 years
    Weight below 40kg
    Moderate hepatic impairment

    Precautions and Warnings

    Females of childbearing potential
    Predisposition to prolongation of QT interval
    Electrolyte imbalance
    End stage renal disease
    Severe renal impairment

    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products
    Advise patients to avoid green tea and green tea products
    Female: Contraception required during and for 1 month after treatment
    Female: Effect of hormonal contraceptive may be reduced

    Women using oral hormonal contraceptives particularly desogestrel, may be required to switch to an alternative method of effective contraceptive, such as barrier method, injectable progesterone or combination oral hormonal contraception.

    If treatment is required in patients with risk factors for QT prolongation, appropriate monitoring and dose adjustments should be considered.

    Pregnancy and Lactation


    Berotralstat is contraindicated during pregnancy.

    Use of berotralstat during pregnancy is contraindicated by the manufacturer. Animal studies and human data is limited and as such a potential risk to the foetus cannot be ruled out.


    Berotralstat is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues berotralstat or discontinues breastfeeding, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Animal data has shown excretion of berotralstat in milk. Effects on exposed infants are unknown.

    Side Effects

    Abdominal pain
    Gastroesophageal reflux
    Increase in serum ALT/AST


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2022

    Reference Sources

    Summary of Product Characteristics: Orladeyo 150mg hard capsules. BioCryst UK Ltd. Revised May 2021.

    NICE Evidence Services Available at: Last accessed: 14 January 2022

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.