Garadacimab is a prescription medicine indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. It is available as injection for subcutaneous use. MedsAcross supplies Garadacimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY 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.
Source: US FDA prescribing information
Garadacimab-gxii is an inhibitor of activated FXII that binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. FXII is the first factor activated in the contact activation pathway and initiates the inflammatory bradykinin-producing kallikrein-kinin system. The inhibition of FXIIa decreases the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks, thus reducing the cascade of events leading to an HAE attack.
Source: US FDA prescribing information
Recommended Dosage: Initial loading dose of 400 mg (two 200 mg injections) administered subcutaneously followed by maintenance dosage of 200 mg once monthly. Subcutaneous use only. Patients may self-administer. See full prescribing information for preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Most common adverse reactions (incidence ≥ 7%) are nasopharyngitis and abdominal pain.
Source: US FDA prescribing information
Drug Interference with Laboratory Test: ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.
Source: US FDA prescribing information
Store the prefilled autoinjector and prefilled syringe with needle safety device refrigerated at 36°F to 46°F (2°C - 8°C).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Garadacimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Andembry 200 mg/1.2 mL injectionSubcutaneous Cold chain | Csl | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Garadacimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Garadacimab, including Andembry.
Yes. The US FDA first approved Garadacimab on 16 June 2025, according to Drugs@FDA.
Yes. Garadacimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Garadacimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Garadacimab is classified under ATC code B06AC07 (Garadacimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.