Andembry (garadacimab-gxii) for hereditary angioedema

Last updated June 23, 2025, by Marisa Wexler, MS
Fact-checked by Joana Carvalho, PhD

What is Andembry for hereditary angioedema?

Andembry (garadacimab-gxii) is an antibody therapy for people with hereditary angioedema (HAE) that’s approved as a prophylactic treatment to prevent swelling attacks.

The therapy is designed to inhibit activated factor XII (FXIIa), a clotting protein that, when active, sets off a chain of events that triggers swelling attacks in HAE patients. By blocking FXIIa, Andembry aims to stop this signaling chain of events and prevent swelling. Andembry is the first approved HAE treatment that works by specifically targeting FXIIa.

Developed by CSL Behring, the treatment is given via subcutaneous, or under-the-skin, injections that can be self-administered by patients or given by a caregiver after proper training.

Therapy snapshot

Who can take Andembry?

A prophylactic therapy, Andembry is approved in the U.S. to prevent swelling attacks in adult and pediatric patients, ages 12 and older, with HAE. The therapy is also approved for the same indication in the European Union and other regions and countries worldwide.

Andembry’s U.S. prescribing information lists no contraindications to its use.

How is Andembry administered?

Andembry is administered by subcutaneous injections given every month. Injections may be self-administered by patients or given by caregivers who have received appropriate training from medical experts.

The therapy is available as a single-dose prefilled autoinjector or a single-dose prefilled syringe, each of which contains 200 mg of the Andembry’s active ingredient. On the first day of treatment, patients receive a loading dose of 400 mg, given as two injections of 200 mg each, with subsequent injections being given every month at a maintenance dose of 200 mg.

These subcutaneous injections can be administered into the thigh, abdomen, and upper arm; injections in the abdomen must be at least one inch away from the navel.

Andembry in clinical trials

Andembry’s U.S. approval was based on data from the Phase 3 VANGUARD clinical trial (NCT04656418), which tested the therapy against a placebo in 64 people with HAE types 1 or 2, ages 12 and older, who had experienced at least three swelling attacks in the three months before entering the trial. The results showed that, after six months:

• the monthly HAE attack rate was 89.2% lower with Andembry compared with the placebo
• monthly rates for attacks requiring on-demand treatment and for moderate or severe attacks were lower for patients on Andembry than for those on the placebo
• nearly two-thirds (62%) of patients on Andembry were free from swelling attacks, whereas all patients on the placebo experienced swelling attacks during the study.

Most patients who completed VANGUARD joined others in an extension study (NCT04739059) that is assessing the long-term safety and efficacy of Andembry. Available data from the extension study showed Andembry had a favorable safety profile and continued providing protection against swelling attacks after a year or longer.

CSL also is sponsoring a Phase 3 trial (NCT05819775) to test Andembry in children ages 2-11 with HAE. The goal of this study is to evaluate the therapy’s safety, efficacy, and pharmacological properties in younger patients.

Common side effects of Andembry

The most common side effects of Andembry include:

• cold-like symptoms (nasopharyngitis)
• abdominal pain.

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