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Hereditary Angioedema
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Posters
Integrated safety and efficacy of garadacimab for hereditary angioedema prophylaxis across 3 clinical trials: Phase 2, pivotal Phase 3, and open-label extension studies - AAAAI 2024
A Phase 1, Randomized, Open-Label, Parallel-Group Study Comparing Pharmacokinetic Properties of Garadacimab Administered by Subcutaneous Pre-filled Syringe Assembled to Autoinjector/Pre-filled Pen versus Pre-filled Syringe Assembled to Needle Safety Device in Healthy Adults - AAAAI 2024
Population pharmacokinetic/pharmacodynamic analysis of garadacimab in patients with hereditary angioedema - AAAAI 2024
Garadacimab For Hereditary Angioedema Prophylaxis In Adolescents: Efficacy And Safety From The Phase 3 (VANGUARD) Study And Open-Label Extension (Second Interim Analysis) - AAAAI 2024
Long-term safety and efficacy with garadacimab for hereditary angioedema prophylaxis in an open-label extension study (second interim analysis) - WSAAI 2024
Early onset of protection against hereditary angioedema attacks from Week 1 with garadacimab in pivotal Phase 3 (VANGUARD) study - ACAAI 2023
Long-term quality-of-life and patient-reported improvements with garadacimab for hereditary angioedema: Phase 3 open-label extension study (NCT04739059) - ACAAI 2023
Garadacimab for hereditary angioedema (HAE) prophylaxis: long-term efficacy and safety from the Phase 3 VANGUARD trial and first interim analysis of the open-label extension trial
Garadacimab for hereditary angioedema prophylaxis in adolescents: efficacy and safety from the VANGUARD Phase 3 and 3b open-label extension trial (first interim analysis)
Efficacy and safety of subcutaneous garadacimab for the prophylaxis of hereditary angioedema (HAE) attacks in adult and adolescent patients with HAE: results from a multicenter, placebo-controlled Phase 3 trial
Exploring Patient Treatment Experience with Subcutaneous C1INH Prophylaxis for Hereditary Angioedema:
Impact on Breakthrough Attacks, Quality of Life, and Rescue Medication Use
Retrospective Analysis of Patient Outcomes Associated with Subcutaneous C1INH Prophylaxis for Hereditary Angioedema
Exploring the Quality of Life Benefits of Subcutaneous C1-Inhibitor (C1-INH) Replacement Therapy Using Qualitative Research Methods
Weight-based Dosing of Subcutaneous C1-Inhibitor Facilitates Management of Hereditary Angioedema in Obese Patients
Retrospective Analysis of Patient Outcomes Associated with Subcutaneous C1INH Prophylaxis for Hereditary Angioedema
Burden of Autoimmune Disorder - 2020 AAAAI poster
Key Publications
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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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.
