FIRAZYR

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.

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.

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. 2). 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. 4). 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.

Laryngeal attacks Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe. Ischemic heart disease Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2.

3). Stroke Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin.

Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke. Caregiver/self-administration For patients who have 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 or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice. 2). There are no data on administering subsequent doses for the same attack in adolescents or children.

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. ’ Paediatric population There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.

1.