Hereditary Angioedema

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HAE Information	Educational Materials	Key Publications	CSL HAE Products

Posters

Being Attack-Free With Garadacimab Improves Quality of Life in Patients With Hereditary Angioedema - ACAAI 2024

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Characterization Of Injection Site-Related Adverse Events With Garadacimab In Patients With Hereditary Angioedema - ACAAI 2024

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Clinical Evidence With Garadacimab Demonstrates No Impact on Hemostasis - ACAAI 2024

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Pharmacometric Analysis Supports Early Onset of Protection With Garadacimab Against Hereditary Angioedema Attacks - ACAAI 2024

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Low Incidence of Garadacimab Immunogenicity With No Impact on Efficacy, Safety, or Pharmacokinetics: Integrated Analysis - ACAAI 2024

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Long-term efﬁcacy and safety of subcutaneous garadacimab for prophylaxis of HAE attacks: Results from a multicenter phase 3 study (VANGUARD) and open-label extension - EAACI 2023

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Garadacimab provides early onset of protection against HAE attacks from Week 1 after first administration- EAACI 2024

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Being attack-free is associated with improved quality of life for patients with hereditary angioedema treated with garadacimab: Post hoc analysis from the pivotal Phase 3 (VANGUARD) study - EAACI 2024

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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

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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

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Population pharmacokinetic/pharmacodynamic analysis of garadacimab in patients with hereditary angioedema - AAAAI 2024

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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

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Long-term safety and efficacy with garadacimab for hereditary angioedema prophylaxis in an open-label extension study (second interim analysis) - WSAAI 2024

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Long-term quality-of-life and patient-reported improvements with garadacimab for hereditary angioedema: Phase 3 open-label extension study (NCT04739059) - ACAAI 2023

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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

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Garadacimab for hereditary angioedema prophylaxis in adolescents: efficacy and safety from the VANGUARD Phase 3 and 3b open-label extension trial (first interim analysis)

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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

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Exploring Patient Treatment Experience with Subcutaneous C1INH Prophylaxis for Hereditary Angioedema: Impact on Breakthrough Attacks, Quality of Life, and Rescue Medication Use

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Please see full prescribing information for HAEGARDA

Retrospective Analysis of Patient Outcomes Associated with Subcutaneous C1INH Prophylaxis for Hereditary Angioedema

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Please see full prescribing information for HAEGARDA

Exploring the Quality of Life Benefits of Subcutaneous C1-Inhibitor (C1-INH) Replacement Therapy Using Qualitative Research Methods

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Please see full prescribing information for HAEGARDA

Weight-based Dosing of Subcutaneous C1-Inhibitor Facilitates Management of Hereditary Angioedema in Obese Patients

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Please see full prescribing information for HAEGARDA

Durability of Symptom Control with Long-term Prophylactic Therapy With Subcutaneous C1-Inhibitor in Patients With Hereditary Angioedema

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Please see full prescribing information for HAEGARDA

Burden of Autoimmune Disorder - 2020 AAAAI poster

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Please see full prescribing information for HAEGARDA

Key Publications

Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open-label extension study

Reshef A, Hsu C, Katelaris CH, et al.
Allergy. 2024
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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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Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Craig TJ, Reshef A, Li HH, et al.
Lancet. 2023
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Garadacimab for the prevention of hereditary angioedema attacks: a plain language summary of the VANGUARD study

Craig TJ, Reshef A, Li HH, et al.
Future Rare Dis. 2023
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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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Long-term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks

Craig T, Zuraw B, Longhurst H, et al.
J Allergy Clin Immunol Pract 2019
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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.