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New or revised text is show in bold type:
- Section 4.2 (Posology and method of administration) was revised to include instructions for self administration. Special populations was revised.
Firazyr is intended for subcutaneous administration preferably in the abdominal area.
Firazyr is intended for use under the guidance of a healthcare professional.
Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
The decision on initiating self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4).
Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe.
Each Firazyr syringe is intended for single use only.
Posology
The recommended dose is a single subcutaneous injection of Firazyr 30 mg.
Firazyr solution for injection should be injected slowly due to the volume to be administered (3 ml).
Special populations
Paediatric population
The safety and efficacy of Firazyr in children aged 0-18 years has not been established.
No pediatric data are available.
- Section 4.4 (Special warnings and precautions for use) was revised to include self administration.
Self-administration
For patients who never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician.
In case of insufficient relief or recurrence of symptoms after self-treatment, it is recommended that the patient should seek medical advice and that subsequent doses are given in a medical institution (see section 4.2).
Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home.
- Section 4.6 (Fertility, pregnancy and lactation) was revised to add the subheaders Pregnancy, Breastfeeding, and Fertility.
- In section 4.8 (Undersirable effects) was revised to include information from a self administration study. The description of reactions at the site of injection was revised.
The safety of icatibant has been established in 1304 subjects treated with various doses, regimens and routes of administration during Phase I‑III studies in various indications.
Sixty three (HAE) patients received icatibant in two Phase III trials for treatment of an attack in the controlled phase and 126 patients were treated in the open label phase.
Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation). These reactions were generally mild in severity, transient, and resolved without further intervention.
Self-administration:
In an open-label study, the safety profile of the patients who self-administered Firazyr was similar to that administered by healthcare professionals.
- Section 5.1 (Parmacodynamic properties) was revised to include cardiac therapy.
Pharmacotherapeutic group: cardiac therapy, other cardiac preparations, ATC code: C01EB19.
- Minor editorial revisions were made to sections 5.2 (Pharmacokinetic properties) and 6.3 (Shelf life).
- Minor editoral revisions were made to the the titles of sections 6.5 (Nature and contents of container), and 6.6 (Special precautions for disposal)
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