Indication
FIRAZYR® (icatibant injection) is indicated for the treatment of acute attacks
of hereditary angioedema (HAE) in adults 18 years of age and older.
Important Safety Information
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 Takeda at 1-877-TAKEDA-7 (1-877-825-3327) or the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
