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HAEGARDA ®

C1 Esterase Inhibitor Subcutaneous (Human)
Full Prescribing Information for HAEGARDA®        Important Safety Information

HAEGARDA is the only C1 esterase inhibitor for subcutaneous injection for the prevention of HAE attacks in adolescents and adults.

Visit www.HAEGARDA.com to learn more.

Diagnostic Codes (ICD-10-CM)

Billing Codes (HCPCS, NDC, CPT)

Medicare Part B ASP Pricing Limits

Authorized Distributors

Safety Data Sheets

Important Safety Information for HAEGARDA

HAEGARDA® is contraindicated in patients with a history of life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or their excipients.

Severe hypersensitivity reactions to HAEGARDA could occur. In such cases, discontinue administration and institute appropriate treatment. Epinephrine should be immediately available to treat hypersensitivity reactions.

At the recommended subcutaneous dose of HAEGARDA, no causal relationship to thromboembolic events (TEs) has been established. However, TEs have been reported with intravenous administration of C1-INH products, usually at high doses.

In clinical trials, adverse reactions observed in more than 4% of subjects treated with HAEGARDA were injection-site reactions, hypersensitivity, nasopharyngitis, and dizziness.

HAEGARDA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

HAEGARDA, C1 Esterase Inhibitor Subcutaneous (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. HAEGARDA is for subcutaneous use after reconstitution only.

Please see full prescribing information for HAEGARDA.


CRP16-05-0001 05/2016
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