From Ethics to Application: Integrating Generative AI into Health Informatics Graduate Training
December 17, 2025
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Brand Name :
Andembry, garadacimab-gxii
Synonyms :
Garadacimab
Class :
Monoclonal Antibodies
Brand Name :
Andembry, garadacimab-gxii
Synonyms :
Garadacimab
Class :
Monoclonal Antibodies
Dosage forms & Strengths:
Solution for SC injection
200mg/1.2mL as single-dose prefilled autoinjector or syringe
Administer initial dose of 400 mg (two 200-mg injections) through subcutaneous route, followed by maintenance dose 1 month later
Administered dose of 200 mg through subcutaneous route monthly
Dosage forms & Strengths:
Solution for SC injection
200mg/1.2mL as single-dose prefilled autoinjector or syringe
Hereditary Angioedema
<12 years: Safety and efficacy not established
For ≥12 years old:
Administer initial dose of 400 mg (two 200-mg injections) through subcutaneous route, followed by maintenance dose 1 month later
Administered dose of 200 mg through subcutaneous route monthly
<12 years: Safety and efficacy not established
For ≥12 years old:
Administer initial dose of 400 mg (two 200-mg injections) through subcutaneous route, followed by maintenance dose 1 month later
Administered dose of 200 mg through subcutaneous route monthly
Geriatric
Refer to the adult dosing
Actions and Spectrum
Activated Factor XII (FXIIa) is inhibited by monoclonal antibodies.
The inflammatory bradykinin-producing kallikrein-kinin system is started by FXII, the first factor to activate in the contact activation pathway.
FXIIa inhibition reduces the cascade of events that lead to a HAE attack by lowering the activation of prekallikrein to kallikrein and the production of bradykinin, which are linked to inflammation and edema in HAE attacks.
Frequency defined
>10%
Nasopharyngitis
Injection site reactions
1-10%
Abdominal pain
Prolonged aPTT, >1.4x ULN
Black Box Warning
None
Contraindication/Caution
Contraindication:
None
Caution:
It has the potential to extend the activated partial thromboplastin time (aPTT) because of its interaction with the aPTT test.
Garadacimab’s suppression of plasma FXIIa can prolong aPTT in the aPTT laboratory test because the reagents employed in this test cause intrinsic coagulation by activating FXII in the contact system.
Pregnancy/Lactation
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
Hereditary angioedema (HAE) prevention is the main goal of the development of garadacimab.
Bradykinin production is a major mediator of pain, increased vascular permeability, and vasodilation.
Garadacimab prevents downstream bradykinin production and kallikrein activation by inhibiting FXIIa.
Pharmacodynamics:
A more stable bradykinin milieu and fewer HAE attacks are the results of sustained FXIIa inhibition.
It provides a different mechanism of action than bradykinin receptor blockers or kallikrein inhibitors.
The reduced HAE attack frequency, duration, and severity are correlated with PD indicators.
Pharmacokinetics:
Absorption
It has absolute bioavailability of 39%.
The peak plasma time is achieved in 6 days.
Distribution
The volume of distribution is 11.8 L.
Metabolism
It is metabolized into small peptides by catabolic pathways.
Elimination and Excretion
The half-life is 17.4 days.
The systemic clearance rate is 0.02 L/hr.
Administration
Administered for one-time monthly subcutaneous route.
Administered in the abdomen or thigh, at least 1 inch away from the navel.
Physician should administer subcutaneously in upper arm.
Use the sharps disposal container to dispose of the used autoinjector or syringe.
Patient information leaflet
Generic Name: garadacimab
Pronounced: An-DEM-bree
Why do we use garadacimab?
On June 16, 2025, the FDA approved Andembry (aradacimab-gxii) after the placebo-controlled Phase 3 VANGUARD trial showed promising results.
Garadacimab is used to prevent attacks of Hereditary Angioedema (HAE).
It decreases the production of bradykinin and stops prekallikrein from activating to kallikrein.
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