Generic Name
Icatibant
Drug Description
Each prefilled syringe of 3 ml contains icatibant acetate equivalent to 30 mg icatibant. Each ml of the solution contains 10 mg of icatibant
Presentation
Solution for injection.The solution is a clear and colourless liquid.
Indications
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Adult Dosage
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.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.PosologyThe 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).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.Special populationsElderly patientsLimited information is available on patients older than 65 years of age.Elderly patients have been shown to have increased systemic exposure to icatibant. The relevance of this to the safety of Firazyr is unknown.Hepatic impairmentNo dosage adjustment is required in patients with hepatic impairment.Renal impairmentNo dosage adjustment is required in patients with renal impairment.Paediatric populationThe safety and efficacy of Firazyr in children aged 0-18 years has not been established.No pediatric data are available.
Child Dosage
The safety and efficacy of Firazyr in children aged 0-18 years has not been established.No pediatric data are available.
Elderly Dosage
Limited information is available on patients older than 65 years of age.Elderly patients have been shown to have increased systemic exposure to icatibant. The relevance of this to the safety of Firazyr is unknown.
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Self-administrationFor 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.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.Ischemic heart diseaseUnder ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2. Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris.StrokeAlthough 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.
Interactions
Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2)Co-administration of Firazyr with ACE inhibitors has not been studied. ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels
Adverse Reactions
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.The frequency of adverse reactions listed in Table 1 is defined using the following convention:Very common (1/10); common (1/100, <1/10); uncommon (1/1,000, <1/100); rare (1/10,000, <1/1,000); very rare (<1/10,000).Note: Due to the low number of patients, each of the uncommon events has only been reported in a single patient.Table 1: Adverse reactions reported with icatibant in the phase III clinical trials.Adverse reactionsVery commonCommonUncommonCongenital, familial and genetic disordersHereditary angioedema*Gastrointestinal disordersNausea, vomitingGeneral disorders and administration site conditionsInjections site reactions (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation)Asthenia, fatigue, pyrexiaInfections and infestationsHerpes zoster, pharyngitisInjury, poisoning and procedural complicationsContusionInvestigationsBlood creatinine phosphokinase increased, prothrombin time prolongedWeight increased, blood glucose increased, liver function test abnormalMetabolism and nutrition disordersHyperuricaemia, hyperglycaemiaMusculoskeletal and connective tissue disordersMuscle spasmNervous system disordersDizziness, headacheRenal and urinary disordersProteinuriaRespiratory, thoracic and mediastinal disordersAsthma, cough, nasal congestionSkin and subcutaneous tissue disordersRash, pruritus, erythemaGeneralised urticariaVascular disordersHot flush* HAE attacks were reported as adverse reactions, however based on time of occurrence, the majority were recurrent attacks and not related to treatment with Firazyr.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.
Manufacturer
Shire Human Genetic Therapies
Drug Availability
(POM)
Updated
22 November 2011
