Andembry (garadacimab)
An approved treatment for Hereditary Angioedema.
The same compound appears under different names depending on the context. Here is how to identify Garadacimab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Garadacimab
- Brand name
- Andembry
- Development code
- CSL312
- Drug class
- Activated Factor XII inhibitor (monoclonal antibody)
- Manufacturer
- CSL Behring
- How it's taken
- A loading dose of 400 mg, given as 2 subcutaneous injections of 200 mg on the first day, then 200 mg subcutaneously once a month.
A once-monthly self-injection that prevents hereditary angioedema attacks by blocking Factor XII, a target no earlier HAE drug used. Andembry reduced attacks by 89% versus placebo and its label lists no warnings or precautions.
Where Garadacimab fits
The newest antibody for HAE prevention and the first with a Factor XII target. Against Takhzyro it offers monthly rather than fortnightly dosing and a clean warnings section; against Orladeyo it offers a far larger attack reduction in exchange for an injection.
How Garadacimab works
The chain of events behind an HAE attack starts with Factor XII, which activates prekallikrein into plasma kallikrein, which in turn releases bradykinin and causes swelling. Earlier prophylactic drugs act on kallikrein, one step down. Garadacimab is an antibody that binds activated Factor XII and blocks it at the top of the cascade, so less kallikrein is activated and less bradykinin is made. Because the antibody persists for weeks, one injection a month is enough.
Mechanism: Monoclonal antibody that blocks activated Factor XII, the very first step of the cascade that produces bradykinin, preventing hereditary angioedema attacks with a once-monthly injection
Side effects and safety
- The label lists no warnings or precautions
The label lists no warnings and precautions, which is unusual. The most common reactions, in at least 7% of patients, were nasopharyngitis and abdominal pain. Suspected reactions can be reported to CSL Behring at 1-866-915-6958.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Garadacimab
A loading dose of 400 mg, given as 2 subcutaneous injections of 200 mg on the first day, then 200 mg subcutaneously once a month. Supplied as a prefilled autoinjector or prefilled syringe, and patients can self-administer at home.
Availability and cost
Only available as the brand-name product.
A monthly monoclonal antibody for a rare disease, in the same cost tier as other HAE biologics. Twelve injections a year is the lowest frequency of any HAE antibody, which matters for both convenience and for the drug quantity insurers see.
Help paying for Andembry
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
CSL Behring copay program may cover eligible out-of-pocket costs for commercially insured patients; subject to terms and conditions.
For: private insurance · source - Bridge or quick-start supply
QuickStart Program ships a 1-month supply at no cost; eligible patients may get up to 2 months free during insurance approval.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
Dedicated case manager helps with insurance navigation; nursing team offers injection training and product support.
The official page does not say who qualifies. Ask the program. · source
Good to know: The Andembry page also mentions help getting therapy at little to no cost and resources for government-insured patients, but does not give eligibility details. CSL Behring lists Andembry as part of its copay program.
- From a charity · The Assistance FundHereditary Angioedema (HAE) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.” - From a charity · US Hereditary Angioedema AssociationChris Whalen HAEA Compassion Fund fundApply directly
Pays for: Travel to care for HAE-related reasons (e.g. seeing a specialist).
The foundation says: “Status not shown on page”
Access and eligibility
Approved for prophylaxis in adults and children aged 12 and older. It is preventive only; patients keep an on-demand therapy for breakthrough attacks. The trial required at least 1 attack a month on average, so it targets patients who get attacks regularly.
Source: FDA Drugs@FDA (BLA 761367)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
The VANGUARD trial (NCT04656418) randomized 64 patients aged 12 and older with type I or II HAE, each with at least 2 attacks in the 2 months before treatment, 3 to 2 to garadacimab or placebo for 6 months. The monthly attack rate was 0.22 on garadacimab against 2.07 on placebo, a reduction of 89.2% (95% CI 75.6% to 95.2%). Attacks needing on-demand treatment fell 91.2% and moderate or severe attacks 93.6%. Most patients were adults with type I disease and a third had been on prophylaxis in the prior 3 months.
Development history
Developed by CSL Behring as CSL312 and approved by the FDA on June 16, 2025, the first HAE therapy to target Factor XII and the first of 3 new HAE approvals that summer, followed by Ekterly in July and Dawnzera in August.
Explore Hereditary Angioedema trials
Other Hereditary Angioedema treatments
Common questions about Garadacimab
▸What is Garadacimab (Andembry)?
A once-monthly self-injection that prevents hereditary angioedema attacks by blocking Factor XII, a target no earlier HAE drug used. Andembry reduced attacks by 89% versus placebo and its label lists no warnings or precautions.
▸How does Garadacimab work?
The chain of events behind an HAE attack starts with Factor XII, which activates prekallikrein into plasma kallikrein, which in turn releases bradykinin and causes swelling. Earlier prophylactic drugs act on kallikrein, one step down. Garadacimab is an antibody that binds activated Factor XII and blocks it at the top of the cascade, so less kallikrein is activated and less bradykinin is made. Because the antibody persists for weeks, one injection a month is enough.
▸What are the side effects of Garadacimab?
The label lists no warnings and precautions, which is unusual. The most common reactions, in at least 7% of patients, were nasopharyngitis and abdominal pain. Suspected reactions can be reported to CSL Behring at 1-866-915-6958.
▸How is Garadacimab taken?
A loading dose of 400 mg, given as 2 subcutaneous injections of 200 mg on the first day, then 200 mg subcutaneously once a month. Supplied as a prefilled autoinjector or prefilled syringe, and patients can self-administer at home.
▸Is Garadacimab FDA approved?
Yes, Garadacimab (Andembry) is FDA approved (2025) for the treatment of Hereditary Angioedema.
▸What is Andembry approved for?
Andembry (garadacimab) is approved to prevent hereditary angioedema attacks in adults and children aged 12 and older. The FDA approved it on June 16, 2025. It is the first HAE therapy that works by blocking activated Factor XII rather than plasma kallikrein.
▸How well does Andembry prevent attacks?
In the 6-month VANGUARD trial of 64 patients, attacks fell 89% compared with placebo, from about 2 a month to about 1 every 5 months. Attacks needing on-demand treatment fell 91% and moderate or severe attacks 94%.
▸How often is Andembry injected?
Once a month, after a first-day loading dose of 400 mg given as 2 injections. Patients can self-inject at home with a prefilled autoinjector or syringe. That is the least frequent dosing of any HAE antibody.
▸What are the side effects of Andembry?
The label lists no warnings or precautions. The most common side effects were nasopharyngitis and abdominal pain, each in at least 7% of patients.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- CSL Behring / FDA · 2025-06. ANDEMBRY (garadacimab-gxii) injection, for subcutaneous use: US Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=ANDEMBRY
- U.S. Food and Drug Administration · 2025-06-16. ANDEMBRY approval, BLA 761367, June 16 2025. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761367
- ClinicalTrials.gov. Efficacy and Safety Study of Garadacimab in the Prophylactic Treatment of HAE (VANGUARD). https://clinicaltrials.gov/study/NCT04656418