Hereditary Angioedema
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Posters
Key Publications
Timing of Onset of Garadacimab for Preventing Hereditary Angioedema Attacks
Staubach P, Tachdjian R, Li HH, et al.Clin Exp Allergy. 2024
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Hereditary angioedema with normal C1 esterase inhibitor: Current paradigms and clinical dilemmas
Radojicic C, Anderson J.Allergy Asthma Proc. 2024
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Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor
Longhurst H, Cicardi M, Craig T, et al.N Engl J Med 2017
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J Allergy Clin Immunol Pract 2019
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Important Safety Information for ANDEMBRY
ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
The most common adverse reactions in the pivotal trial (incidence =7%) were nasopharyngitis and abdominal pain. In the pivotal trial and the open-label extension study, injection-site reactions (eg, injection-site bruising, injection-site erythema, injection-site hematoma, injection-site pruritus, injection-site urticaria) were reported in 23 (14%) patients.
No dedicated drug interaction studies have been conducted, nor is there data concerning the use of ANDEMBRY in women who are pregnant or breastfeeding. The safety and efficacy of ANDEMBRY in patients under 12 years of age have not been established.
Drug Interference with Laboratory Test: ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.
Please see full prescribing information for ANDEMBRY.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Important Safety Information for HAEGARDA
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 patients 6 years of age and older. HAEGARDA is for subcutaneous use after reconstitution only.
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.
Please see full prescribing information for HAEGARDA.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
