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Andembry (garadacimab-gxii) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help prevent hereditary angioedema (HAE) attacks in adults and children ages 12 years and older.
Andembry is an activated factor XII (12) inhibitor. It blocks activated factor XII, a protein involved in a chain reaction that can lead to swelling. This lowers the production of bradykinin, a substance linked to inflammation and swelling during HAE attacks.
Doctors prescribe Andembry to help prevent HAE attacks in adults and children aged 12 years and older.
Andembry is injected under the skin. After proper training, you or a caregiver may give the injection at home.
For self-injection, use the thigh or abdomen. Stay at least 1 inch, or 2 centimeters, away from the belly button. A caregiver may also inject it into the upper arm. Do not inject yourself in the upper arm.
Change the injection site each time. Do not inject into the belly button, moles, scars, bruises, or skin that is tender, red or discolored, hard, or injured.
The recommended loading dose is 400 milligrams on the first day of treatment. This is given as two 200-milligram injections under the skin.
After that, the recommended dose is 200 milligrams under the skin every month.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies, the most common side effects of Andembry occurred in about 8 percent to 21 percent of people. These include:
None are listed in the prescribing information.
Get medical help right away if you think you are having a serious reaction.
CSL Behring, the manufacturer of Andembry, offers Andembry Connect. Eligible people with commercial insurance may be able to receive copay support. The program also provides information about financial assistance options for eligible people with government insurance.
Andembry Connect also offers personalized support from a dedicated case manager, self-administration training from a dedicated nursing team, insurance navigation, access to the QuickStart Program, and the opportunity to connect with an Andembry advocate who has personal experience living with HAE.
To learn more, visit the Andembry Connect webpage or call 844-423-4273.
Tell your doctor if you have any allergies to garadacimab-gxii or any ingredients in Andembry.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
If you miss a dose of Andembry, take it as soon as possible.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Andembry, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Andembry for HAE?
In a six-month study of 64 people aged 12 years and older with type 1 or type 2 HAE, the monthly HAE attack rate was 0.22 with Andembry and 2.07 with placebo.
This was an 89.2 percent reduction in monthly HAE attacks compared with placebo. Andembry also reduced attacks needing on-demand treatment by 91.2 percent and reduced moderate or severe attacks by 93.6 percent.
How long does Andembry take to work for HAE?
Andembry began blocking its target pathway after the first dose. The clinical study does not say exactly when a person may begin to notice fewer HAE attacks.
What tests or monitoring are needed with Andembry for HAE?
The prescribing information does not require routine blood tests or a set monitoring schedule for Andembry.
Andembry can make the activated partial thromboplastin time (aPTT) test take longer because it can interfere with the laboratory test. The aPTT test measures how long it takes blood to clot through one part of the clotting process.
In the main clinical trial, some people also had longer prothrombin time (PT) and international normalized ratio (INR) results. PT measures how long it takes blood to clot through a different part of the clotting process. INR is a standardized way of reporting the PT result so it can be compared across laboratories.
These changes were not linked to bleeding events.
On myHAEteam, people share their experiences with HAE, get advice, and find support from others who understand.
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