Warnings and precautions: Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with FIRAZYR.
Adverse reactions: The most commonly reported adverse reactions were injection-site reactions, which occurred in almost all patients (97%) in clinical trials. These injection-site reactions included bruising, hematoma, burning, erythema, hypoesthesia, irritation, numbness, edema, pain, pressure sensation, pruritus, swelling, urticaria, and warmth.
Other common adverse reactions included pyrexia (4%), transaminase increase (4%), and dizziness (3%), as well as rash, nausea, and headache.
Drug interactions: FIRAZYR is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.
Use in specific populations:
Clinical studies of FIRAZYR included a limited number of subjects aged 65 and over. Elderly patients are likely to have increased systemic exposure. Reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients.
Safety and effectiveness in patients below 18 years of age have not been established.
Please see the full Prescribing Information.
To report suspected adverse events, please contact Shire at 1-800-828-2088 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
FIRAZYR® (icatibant injection) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.