Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
Firazyr is intended for use under the guidance of a healthcare professional.
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.
The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.
Table 1. Dosage regimen for paediatric patients:
| Body Weight | Dose (Injection Volume) |
|---|---|
| 12 kg to 25 kg | 10 mg (1.0 ml) |
| 26 kg to 40 kg | 15 mg (1.5 ml) |
| 41 kg to 50 kg | 20 mg (2.0 ml) |
| 51 kg to 65 kg | 25 mg (2.5 ml) |
| >65 kg | 30 mg (3.0 ml) |
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.
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).
No dose adjustment is required in patients with hepatic impairment.
No dose adjustment is required in patients with renal impairment.
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.
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).
Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
Firazyr may be administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
No clinical information on overdose is available.
A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects. No therapeutic intervention was necessary.
2 years.
Do not store above 25°C.
Do not freeze.
3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer). A hypodermic needle (25 G; 16 mm) is included in the pack.
Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
The solution should be clear and colourless and free from visible particles.
Use in the paediatric population
The appropriate dose to be administered is based on body weight (see section 4.2). Where the required dose is less than 30 mg (3 ml), the following equipment is required to extract and administer the appropriate dose:
The pre-filled icatibant syringe and all other components are for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
All needles and syringes should be disposed of in a sharps container.
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