Garadacimab at a glance
Medicine class
Fully human IgG4 monoclonal antibody targeting activated factor XII.
Main role
Prevention of recurrent HAE attacks from age 12 years.
Administration
Injected under the skin using a single-use pre-filled pen; self-injection requires healthcare-professional training.
Acute attacks
Not a rescue treatment; breakthrough attacks require the prescribed acute-attack plan.
What is Garadacimab used for?
Garadacimab is licensed for preventive treatment.
Prevention of recurrent HAE attacks in adults and adolescents aged 12 years and over.
How does Garadacimab work?
Garadacimab binds to activated factor XII and blocks its activity. This interrupts the pathway that generates bradykinin, a key cause of swelling during HAE attacks.
Garadacimab preparations and strengths
Injection
Route: Parenteral
Strengths: 200 mg
How to take Garadacimab
Use the pre-filled pen only after injection training and follow its instructions for use.
Inject under the skin of the abdomen, thigh or upper outer arm, rotating sites.
An adult should supervise administration by an adolescent.
Allow a refrigerated pen to reach room temperature naturally before use; do not heat or shake it.
Do not use a damaged, leaking or dropped pen, or solution containing particles or abnormal discolouration.
Use each pen once and discard it in an appropriate sharps container.
Garadacimab side effects
Common or expected effects
- Injection-site reactions, including redness, bruising, itching or local hives
- Headache
- Abdominal pain
Get urgent medical advice
- Severe allergic reaction, which may include widespread hives, chest tightness, wheezing, breathing difficulty, low blood pressure or anaphylaxis
Garadacimab in pregnancy
Human pregnancy information is limited, so avoiding garadacimab during pregnancy is advised as a precaution. Discuss pregnancy or plans to conceive with the HAE specialist so individual risks and benefits can be reviewed.
Garadacimab while breastfeeding
It is unknown whether garadacimab enters human milk. The benefits of breastfeeding, the mother's need for preventive treatment and possible effects on the infant should be considered with the specialist team, particularly around the first days after birth.
Garadacimab interactions
No established direct medicine interactions are listed, but dedicated human interaction studies are limited.
Anticoagulants and antiplatelet medicines
Experience with combined use is very limited, and the clinical effect of combining garadacimab with some anticoagulants is unknown.
Other long-term preventive HAE treatments
Garadacimab has not been studied in combination with other products used for long-term HAE prevention.
C1-esterase inhibitor products or icatibant
Use as rescue treatment for breakthrough attacks did not affect garadacimab pharmacokinetics in available analyses.
Common questions about Garadacimab
Answers are fully visible for fast scanning and source review.
What is Garadacimab used for?
It prevents recurrent HAE attacks in adults and adolescents aged 12 years and over.
Can Garadacimab treat an HAE attack that has already started?
No. Use the prescribed rescue plan for a breakthrough attack and seek emergency help for breathing or throat symptoms.
Can Garadacimab be self-injected?
Yes, after training by a healthcare professional. A trained caregiver may also administer it, and adolescents require adult supervision.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.