HAEGARDA for the prevention of HAE attacks
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About hereditary angioedema
Hereditary angioedema (HAE) is a rare and potentially life-threatening condition. HAE attacks are unpredictable and vary in frequency, severity, and location. Approximately half of patients with HAE will have at least 1 laryngeal attack in their lifetime.1
Patients with HAE are deficient in the C1 esterase inhibitor (C1-INH) protein or have malfunctioning C1-INH protein and can have several attacks per week, which can range from mild to severe.2-4 With HAE, almost all costs increase with disease severity. ln fact, emergency department and hospitalization costs are more than 100 times greater in severe attacks vs mild attacks.5
C1-INH replacement is currently a preferred long-term prophylaxis for the prevention of HAE attacks, including in pregnant and breastfeeding patients, as well as in children aged ≤12 years.6,7*
*The World Allergy Organization/European Academy of Allergy and Clinical Immunology (WAO/EAACI) 2021 guidelines state that plasma-derived C1-INH is currently a preferred long-term prophylaxis for the prevention of HAE attacks.6 The US Hereditary Angioedema Association (HAEA) Medical Advisory Board 2020 Guidelines state that C1-INH is the preferred therapy for pregnant or breastfeeding patients with HAE and long-term prophylaxis in children.7
What is HAEGARDA?
HAEGARDA, C1 esterase inhibitor subcutaneous (human), is a plasma-derived concentrate that replaces the missing or dysfunctional C1-INH. In the pivotal trial, HAEGARDA 60 IU/kg reduced the number of HAE attacks by a median of 95%. In an exploratory endpoint of the pivotal trial, patients on HAEGARDA experienced fewer severe attacks.8
HAEGARDA is the most cost-effective prophylaxis therapy that is safe and approved for use in patients aged ≥6 years.4,9,10
HAEGARDA provides attack-free days for the long term11
In a subgroup analysis of patients treated with HAEGARDA:
*In a subgroup analysis of 24 U.S. patients receiving 60 IU/kg of HAEGARDA eligible to continue the open-label extension study for >12 months.11
What are the key benefits?
HAEGARDA is indicated for routine prophylaxis to prevent HAE attacks in patients aged ≥6 years. HAEGARDA is for subcutaneous use after reconstitution only.
HAEGARDA is the only C1-INH subcutaneous therapy for the prevention of HAE attacks.
in HAE attacks
vs placebo8*
in use of
rescue medication8†
patients approved
for HAEGARDA use
of patient days were attack free for up to 2.7 years11‡
Please see full prescribing information for HAEGARDA.
The WAO 2021 guideline for the management of HAE states that patients should have HAE rescue medication available at all times.6
*Median reduction in number of attacks in patients receiving 60 IU/kg of HAEGARDA vs placebo.8
†Median reduction in rescue medication use in patients receiving 60 IU/kg of HAEGARDA vs placebo.8
‡In a subgroup analysis of 24 U.S. patients receiving 60 IU/kg of HAEGARDA eligible to continue the open-label extension study for >12 months.11
The value of HAEGARDA
VALUE
6% lower cost than fixed-dose subcutaneous monoclonal antibody prophylaxis therapies for the average patient10*
REDUCTION IN USE OF RESCUE MEDICATION
Additional drug cost savings may be achieved with >99%8† median reduction in rescue medication use compared with placebo
*The mean weight of a patient given HAEGARDA 60 IU/kg in clinical trials was 80 kg.8
†Median reduction in rescue medication use with HAEGARDA 60 IU/kg vs placebo.8
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