Firazyr

/ Takeda

Firazyr is intended for use under the guidance of a healthcare professional.
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 prescribing information.
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. The relevance of this to the safety of Firazyr is unknown.
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.
Caregiver/self-administration: 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 prescribing information for full details.

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.

Hypersensitivity to the active substance or to any of the excipients.

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. Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris.
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.
Paediatric population: There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.
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. For adults, subsequent doses that may be required for the same attack should be administered within a medical institution. 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.
See prescribing information for full details.

Dizziness; headache; nausea; rash; erythema; pruritis, urticaria, injection site reactions, pyrexia, transaminases increased.
See prescribing information for full details.

Pharmacokinetic drug interactions involving CYP450 are not expected.
Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied. ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels.

Pregnancy: For icatibant, no clinical data on exposed pregnancies are available. Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life threatening laryngeal attacks).
Lactation: It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment.
See prescribing information for full details.

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.

Effects on ability to drive and use machines:
Firazyr has minor influence on the ability to drive and use machines. Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of Firazyr. These symptoms may occur as a result of an attack of HAE. Patients should be advised not to drive and use machines if they feel tired or dizzy.
Storage: Do not store above 25°C. Do not freeze.