Drugs List

Therapeutic Indications

Uses

Hereditary angioedema: prophylaxis

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

Contraindications

Children under 12 years
Weight below 40kg
Breastfeeding
Moderate hepatic impairment
Pregnancy

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

Pregnancy

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.

Lactation

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
Diarrhoea
Flatulence
Gastroesophageal reflux
Headache
Increase in serum ALT/AST
Rash
Vomiting

Presentation

Oral formulations of berotralstat.

Drugs List

Therapeutic Indications

Uses

Hereditary angioedema: prophylaxis

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

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Children under 12 years
Weight below 40kg
Breastfeeding
Moderate hepatic impairment
Pregnancy

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

Pregnancy

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.

Lactation

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
Diarrhoea
Flatulence
Gastroesophageal reflux
Headache
Increase in serum ALT/AST
Rash
Vomiting

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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: www.nice.org.uk Last accessed: 14 January 2022