FIRAZYR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG/3ML [SIN17516P]

Product Info

FIRAZYR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG/3ML

[SIN17516P]

Indication

4.1 Therapeutic indications

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

Dosing

4.2 Posology and method of administration

Firazyr is intended for use under the guidance of a healthcare professional.

Posology

Adults

The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg.

In the majority of cases a single injection of Firazyr is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Firazyr can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Firazyr can be administered after a further 6 hours. No more than 3 injections of Firazyr should be administered in a 24 hour period.

In the clinical trials, not more than 8 injections of Firazyr per month have been administered.

Paediatric population

The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.

In the clinical trial, not more than 1 injection of Firazyr per HAE attack has been administered.

No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established.

The recommended paediatric dosing regimen is based on population pharmacokinetic modelling using observed paediatric study data (see Section 5.2 Pharmacokinetic Properties: Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly

Limited information is available on patients older than 65 years of age.

Elderly people have been shown to have increased systemic exposure to icatibant. The relevance of this to the safety of Firazyr is unknown (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment.

Renal impairment

No dose adjustment is required in patients with renal impairment.

Method of administration

Firazyr is intended for subcutaneous administration preferably in the abdominal area.

Firazyr solution for injection should be injected slowly due to the volume to be administered.

Each Firazyr syringe is intended for single use only.

Refer to the patient information leaflet for instructions for use.

Caregiver/self-administration

The decision on initiating caregiver or self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults

Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.

Children and adolescents aged 2–17 years

Firazyr may be administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.