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Firazyr is a brand name for Icatibant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
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.
4 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.
Summary of the safety profile In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional. Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE.
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 6 sensation). These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Tabulated list of adverse reactions The frequency of adverse reactions listed in Table 2 is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).
All adverse reactions from post-marketing experience are italicised.
Table 2:
Adverse reactions reported with icatibant System Organ Class (incidence category) Preferred Term Nervous system disorders (Common, ≥ 1/100 to < 1/10) Dizziness Headache Gastrointestinal disorders (Common, ≥ 1/100 to < 1/10) Nausea Skin and subcutaneous tissue disorders (Common, ≥ 1/100 to < 1/10) Rash Erythema Pruritus (Unknown) Urticaria General disorders and administration site conditions (Very Common, ≥ 1/10) Injection site reactions* (Common, ≥ 1/100 to < 1/10) Pyrexia Investigations (Common, ≥ 1/100 to < 1/10) Transaminases increased * Injection site bruising, Injection site hematoma, Injection site burning, Injection site erythema, Injection site hypoesthesia, Injection site irritation, Injection site numbness, Injection site edema, Injection site pain, Injection site pressure sensation, Injection site pruritus, Injection site swelling, Injection site urticaria, and Injection site warmth.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric Population A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies. Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses).
4 mg/kg based on body weight to a maximum dose of 30 mg. The majority of paediatric patients who were treated with subcutaneous icatibant experienced injection site reactions such as erythema, swelling, burning sensation, skin pain and itching/pruritus; these were found to be mild to moderate in severity and consistent with reactions that have been reported in adults.
Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours. These reactions were erythema, swelling, burning and warm sensation. 7 No clinically significant changes in reproductive hormones were observed during clinical studies.
Description of selected adverse reactions Immunogenicity Across repeated treatment in adults in the controlled phase III trials, transient positivity to anti- icatibant antibodies was observed in rare cases. All patients maintained efficacy.
One Firazyr-treated patient tested positive for anti-icatibant antibodies before and after treatment with Firazyr. This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies. No hypersensitivity or anaphylactic reactions were reported with Firazyr.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.