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  • Firazyr
    / Shire


    Active Ingredient
    Icatibant (as acetate) 30 mg / 3 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 X 3 ml

    partial basket chart 83863 6468

    Dosage

    The recommended dose 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.
    Special populations
    Older people: Limited information is available on patients older than 65 years of age. Older 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.
    Paediatric population: The safety and efficacy of Firazyr in children aged 0-18 years has not been established.
    No data are available.
    Method of administration: Firazyr is intended for subcutaneous administration preferably in the abdominal area.
    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.
    Each Firazyr syringe is intended for single use only.
    Firazyr solution for injection should be injected slowly due to the volume to be administered (3 ml).


    Indications

    Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase-inhibitor deficiency.


    Contra-Indications

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


    Special Precautions

    Caution in patients with acute ischemic heart disease or unstable angina pectoris. Caution in the administration to patients in the weeks following a stroke. See prescribing information for full details.
    Pregnancy and lactation: Should be used during pregnancy only if the potential benefit justifies the potential risk for the fetus. Breastfeeding women should not breastfeed for 12 hours after treatment.


    Side Effects

    GI disorders, erythema, swelling warm sensation, burning, itching, cutaneous pain. Increased blood creatinine phosphokinase, abnormal liver function test, nasal congestion, rash.
    See prescribing information for full details.


    Drug interactions

    Co-administration with ACE inhibitors has not been studied. ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels.


    Pregnancy and Lactation

    Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk for the fetus.
    Breastfeeding: Breastfeeding women should not breastfeed for 12 hours after treatment.


    Manufacturer
    Shire Orphan Therapies GmbH, Germany
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