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
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
30 mg injected subcutaneously in the abdominal area. (2.1)
If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. (2.1)
Do not administer more than 3 injections in 24 hours. (2.1)
Patients may self-administer upon recognition of an HAE attack. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg per mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Laryngeal attacks: Following treatment of laryngeal attacks with FIRAZYR, advise patients to seek immediate medical attention. (5.1)
ADVERSE REACTIONS
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
USE IN SPECIFIC POPULATIONS
Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 09/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Laryngeal Attacks
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Postmarketing experience
7 DRUG INTERACTIONS
7.1 ACE Inhibitors
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FIRAZYR® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
2 DOSAGE AND ADMINISTRATION
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