Drugs List

Therapeutic Indications

Uses

Hereditary angioedema

Icatibant is indicated for treatment of acute attacks of hereditary angioedema in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.

Administration

For subcutaneous injection only.

Self-administration may be considered after appropriate injection technique training and only if considered suitable by a physician experienced in the diagnosis and treatment of angioedema.

Contraindications

Children under 2 years

Precautions and Warnings

Patients over 65 years
Acute ischaemic heart disease
Breastfeeding
Pregnancy
Recent cerebrovascular accident
Unstable angina

Advise ability to drive/operate machinery may be affected by side effects
Laryngeal attacks: Assess patient in suitable facilities before discharge
Administer injection slowly
Treatment to be initiated by medically trained personnel
Breastfeeding: Do not breastfeed & discard milk for 12 hours after therapy
Patient should seek medical advice if usual relief is diminished

Pregnancy and Lactation

Pregnancy

Use icatibant with caution in pregnancy.

The manufacturer advises caution if icatibant is used during pregnancy. Although there is no clinical data on exposed pregnancies, animal studies have shown effects on uterine implantation and parturition, but the risk to humans is unknown.

In the event of an attack of hereditary angioedema in pregnant women, other treatments should be considered due to the lack of information regarding the effects of icatibant on pregnancy. (Briggs 2015)

Lactation

Use icatibant with caution in breastfeeding.

The manufacturer advises caution if icatibant is used during breastfeeding. It is unknown whether icatibant is excreted in human breast milk. However, animal studies have shown that icatibant is excreted in the milk of lactating rats as similar concentrations to in maternal blood. The molecular weight (around 1305) should limit excretion into mature breast milk but mean elimination half-life (1.4 hours). The lack of plasma protein binding may allow some excretion and the effect on a breastfed infant is unknown. As the drug is a peptide, it may be digested in the infant's gut but the infant should be monitored for the most common side effects: pyrexia, increased transaminases, dizziness and rash.

The manufacturer notes that breastfeeding women should not breastfeed for 12 hours after icatibant treatment.

Side Effects

Abnormal liver function tests
Bruising at injection site
Burning (injection site)
Dizziness
Erythema at injection site
Fatigue
Haematoma (injection site)
Headache
Hypoesthesia
Increases in serum transaminases (transient)
Irritation (injection site)
Itching (injection site)
Lethargy
Local pain (injection site)
Nausea
Numbness
Oedema
Pruritus
Pyrexia
Rash
Sensation of pressure
Sensation of warmth
Skin pain
Somnolence
Swelling (injection site)
Tiredness
Urticaria

Presentation

Injection of icatibant.

Drugs List

Therapeutic Indications

Uses

Hereditary angioedema

Icatibant is indicated for treatment of acute attacks of hereditary angioedema in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.

Dosage

Adults

Children

Administration

For subcutaneous injection only.

Self-administration may be considered after appropriate injection technique training and only if considered suitable by a physician experienced in the diagnosis and treatment of angioedema.

Contraindications

Children under 2 years

Precautions and Warnings

Patients over 65 years
Acute ischaemic heart disease
Breastfeeding
Pregnancy
Recent cerebrovascular accident
Unstable angina

Advise ability to drive/operate machinery may be affected by side effects
Laryngeal attacks: Assess patient in suitable facilities before discharge
Administer injection slowly
Treatment to be initiated by medically trained personnel
Breastfeeding: Do not breastfeed & discard milk for 12 hours after therapy
Patient should seek medical advice if usual relief is diminished

Pregnancy and Lactation

Pregnancy

Use icatibant with caution in pregnancy.

The manufacturer advises caution if icatibant is used during pregnancy. Although there is no clinical data on exposed pregnancies, animal studies have shown effects on uterine implantation and parturition, but the risk to humans is unknown.

In the event of an attack of hereditary angioedema in pregnant women, other treatments should be considered due to the lack of information regarding the effects of icatibant on pregnancy. (Briggs 2015)

Lactation

Use icatibant with caution in breastfeeding.

The manufacturer advises caution if icatibant is used during breastfeeding. It is unknown whether icatibant is excreted in human breast milk. However, animal studies have shown that icatibant is excreted in the milk of lactating rats as similar concentrations to in maternal blood. The molecular weight (around 1305) should limit excretion into mature breast milk but mean elimination half-life (1.4 hours). The lack of plasma protein binding may allow some excretion and the effect on a breastfed infant is unknown. As the drug is a peptide, it may be digested in the infant's gut but the infant should be monitored for the most common side effects: pyrexia, increased transaminases, dizziness and rash.

The manufacturer notes that breastfeeding women should not breastfeed for 12 hours after icatibant treatment.

Side Effects

Abnormal liver function tests
Bruising at injection site
Burning (injection site)
Dizziness
Erythema at injection site
Fatigue
Haematoma (injection site)
Headache
Hypoesthesia
Increases in serum transaminases (transient)
Irritation (injection site)
Itching (injection site)
Lethargy
Local pain (injection site)
Nausea
Numbness
Oedema
Pruritus
Pyrexia
Rash
Sensation of pressure
Sensation of warmth
Skin pain
Somnolence
Swelling (injection site)
Tiredness
Urticaria

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: August 2021

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Firazyr 30mg solution for injection pre-filled syringe. Shire Orphan Therapies GmbH. Revised October 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 August 2021