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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use FIRAZYR® (icatibant) safely and effectively. See full prescribing information for FIRAZYR.
FIRAZYR (icatibant) Injection, for subcutaneous use
Initial U.S. Approval: 2011
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INDICATIONS AND USAGE
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FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1)
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DOSAGE AND ADMINISTRATION
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30 mg injected subcutaneously in the abdominal area. (2.1)
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If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. (2.1)
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Do not administer more than 3 injections in 24 hours. (2.1)
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Patients may self-administer upon recognition of an HAE attack. (2.2)
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DOSAGE FORMS AND STRENGTHS
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Injection: 10 mg per mL (3)
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CONTRAINDICATIONS
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None (4)
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WARNINGS AND PRECAUTIONS
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Laryngeal attacks: Following treatment of laryngeal attacks with FIRAZYR, advise patients to seek immediate medical attention. (5.1)
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ADVERSE REACTIONS
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The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Shire Human Genetic Therapies at the OnePath® phone # 1-866-888-0660 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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USE IN SPECIFIC POPULATIONS
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Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. (8.5)
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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling |
Revised: 09/2011 |
