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ANDEMBRY is the first and only prophylaxis
treatment that inhibits the hereditary angioedema
(HAE) cascade at the top

ANDEMBRY is the first and only prophylaxis treatment that inhibits the hereditary angioedema(HAE) cascade at the top

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About hereditary angioedema

Hereditary angioedema (HAE) is a rare, chronic, and potentially life-threatening genetic disorder that involves recurrent, unpredictable attacks of severe swelling (angioedema) throughout the body.1

HAE affects an estimated 1 in 50,000 people in the United States, with attacks often beginning around age 10 years.2,3 Patients with HAE are deficient in the C1 esterase inhibitor (C1-INH) protein or have malfunctioning C1-INH protein, which regulates the complement, contact, and coagulation cascades.2

HAE attacks can vary in number and severity, from several times per week to a few attacks per year.4,5 These attacks can affect multiple points of the body, with laryngeal attacks being especially risky.1,6 Severe laryngeal attacks may be fatal if untreated.2

Attacks may lead to emergency department (ED) visits or hospitalizations. Severe attacks are more than 100 times higher in cost for ED visits and hospitalizations than mild attacks.7

What is 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.

Please see full prescribing information for ANDEMBRY.
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What are the key benefits?

ANDEMBRY is the first and only prophylaxis treatment that inhibits the HAE cascade at the top.

Median reduction icon

Median reduction in monthly HAE attacks vs placebo (P<0.001)8*†

Mean reduction icon

LS mean reduction in the number of HAE attacks vs placebo (P<0.001)8*†

Sustain protection icon

Rapid onset of action from week 1* with sustained protection through 2 years—and counting9,10†

Dosing icon

Once-monthly dosing from the start for all patients

*Data are from a 6-month, randomized, double-blind, placebo-controlled, parallel-group study (VANGUARD) of 64 patients aged 12 years and older with confirmed C1- INH HAE. The primary endpoint was the monthly HAE attack rate at 6 months.
One patient receiving placebo with <30 days of treatment was excluded from analysis as per CSP (n=24).

C1-INH, C1 esterase inhibitor; CSP, clinical study protocol; LS, least squares.

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Important Safety Information

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.

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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.

References:1. Banerji A, Davis KH, Brown TM, et al. Patient-reported burden of hereditary angioedema: findings from a patient survey in the United States. Ann Allergy Asthma Immunol. 2020;124(6):600-607. 2. Lumry WR. Overview of epidemiology, pathophysiology, and disease progression in hereditary angioedema. Am J Manag Care. 2013;19(7)(suppl):s103-s110. 3. Christiansen SC, Davis DK, Castaldo AJ, Zuraw BL.Pediatric hereditary angioedema: onset, diagnostic delay, and disease severity.Clin Pediatr(Phila). 2016; 55(10):935-942. 4. Bernstein JA.HAE update: epidemiology and burden of disease. Allergy Asthma Proc. 2013; 34(1):3-6. 5. Zuraw BL.Clinical practice. Hereditary angioedema. N Engl J Med. 2008; 359(10):1027-1036. 6. Bork K, Meng G, Staubach P, Hardt J. Hereditary angioedema: new findings concerning symptoms, affected organs, and course. Am J Med. 2006; 119(3):267-274. 7. Wilson DA, Bork K, Shea EP, Rentz AM, Blaustein MB, Pullman WE. Economic costs associated with acute attacks and long-term management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010; 104(4):314-320. 8. .Craig TJ, Reshef A, LiHH, et al.Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention(VANGUARD): a global, multicentre, randomised, doubleblind, placebo - controlled, phase 3 trial. [Published correction appears in Lancet. 2023; 401(10384):1266.] Lancet. 2023; 401(10382):1079-1090.doi:10.1016 / S0140 - 6736(23)00350 - 1 9. Staubach P, Tachdjian R, Li HH, et al. Timing of onset of garadacimab for preventing hereditary angioedema attacks.Clin Exp Allergy. 2024; 54(12):1020-1023 10. Magerl M, Reshef A, Farkas H, et al. 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.Poster presented at: European Academy of Allergy and Clinical Immunology(EAACI) Hybrid Congress 2023; June 9-11, 2023; Hamburg, Germany.

ANDEMBRY is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
ANDEMBRY® is a registered trademark of CSL Behring GmbH.

All other trademarks are property of their respective owners.

©2025 CSL Behring LLC.. The product information presented on this page is intended for US residents only.
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