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Icatibant Injection for Hereditary Angioedema (HAE)

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Important Safety Information

Laryngeal attacks: Following treatment of laryngeal attacks with Icatibant Injection, advise patients to seek immediate medical attention.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Icatibant Injection is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where Icatibant Injection may attenuate the antihypertensive effect of ACE inhibitors.

Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified.

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

This Important Safety Information does not include all the information needed to use Icatibant Injection safely and effectively. Please see the full Prescribing Information, including Patient Information.

Indications and Usage

Icatibant Injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of Hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

Laryngeal attacks: Following treatment of laryngeal attacks with Icatibant Injection, advise patients to seek immediate medical attention.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Icatibant Injection is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where Icatibant Injection may attenuate the antihypertensive effect of ACE inhibitors.

Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified.

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

This Important Safety Information does not include all the information needed to use Icatibant Injection safely and effectively. Please see the full Prescribing Information, including Patient Information.

Indications and Usage

Icatibant Injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of Hereditary angioedema (HAE) in adults 18 years of age and older.

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