Andembry
Pronunciation: An-DEM-bree
Generic name: garadacimab-gxii
Brand name: Andembry
Dosage form: single-dose prefilled autoinjector for subcutaneous use (200 mg/1.2mL), single-dose prefilled syringe for subcutaneous use (200 mg/1.2 mL)
What is Andembry?
Andembry is used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years and older. It is given by subcutaneous injection once a month. You can be taught how to self-administer it yourself or a caregiver can give it to you.
Andembry works by inhibiting activated Factor XII, the first factor in the contact activation pathway that triggers bradykinin production. By blocking FXIIa, it prevents prekallikrein activation to kallikrein and reduces bradykinin generation, thereby preventing the inflammatory cascade causing HAE attacks. Andembry belongs to the drug class called activated Factor XII (FXIIa) inhibitors. It is also a monoclonal antibody.
Andembry (aradacimab-gxii) gained FDA approval on June 16, 2025, based on positive results from the placebo-controlled Phase 3 VANGUARD trial (NCT04656418), which demonstrated:
- 62% of patients remained completely attack-free during treatment
- Overall attack rates were reduced by 99% (median) and 89% (mean) compared to placebo
- Similar reductions were seen for attacks requiring on-demand therapy and moderate-to-severe attacks compared to placebo.
Side effects
The most common side effects of Andembry include:
- redness, itchiness, and bruising (injection site reactions)
- stomach (abdominal) pain
- runny or stuffy nose, sneezing, watery eyes (nasopharyngitis).
It is not known if Andembry is safe and effective in children under 12 years of age
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Andembry. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before use
Before you use Andembry, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or planning to become pregnant. It is not known if Andembry can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Andembry passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while using Andembry.
How should I use Andembry?
See the detailed Instructions for Use that come with this Andembry Package Insert about the right way to prepare and inject Andembry. Use it exactly as your healthcare provider tells you to use it.
- Andembry is given as an injection under your skin (subcutaneous) by you or a caregiver once a month.
- It can be injected into the thigh or belly (abdomen) area, but stay 1 inch (2 cm) away from the belly button (navel).
- If somebody else (like a caregiver) gives you the injection, you can also use the upper arm.
- Rotate your injection sites. Do not inject in the same injection site multiple times if you see that the skin is damaged.
- Do not inject into the belly button, moles, scars, or bruises, or areas where the skin is tender, red, hard, or injured.
Your healthcare provider should show you or your caregiver how to prepare and inject your dose of Andembry before you inject yourself for the first time.
- Do not try to inject Andembry unless you have been trained by your healthcare provider.
- Children should inject Andembry under the supervision of an adult.
Before using the prefilled syringe or autoinjector
- Remove the prefilled syringe from the carton box and place it on a clean, flat surface.
- Do not remove the prefilled syringe from the carton box by holding onto the needle cap or plunger. Do not move or pull on the plunger.
- Wait 30 minutes for the medicine to reach room temperature after taking it out of the refrigerator
- Injecting the medicine cold could cause you some discomfort. Do not try to speed up the warming process in any way. Do not microwave the prefilled syringe, run hot water over it, or leave it in direct sunlight.
- Check the expiration date. Do not use if the date has passed.
- Inspect before use.
Andembry prefilled syringe
This prefilled syringe works differently from other injection devices. Read the Instructions for Use carefully before using it, and each time you get a new prefilled syringe. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Make sure you have been trained by your healthcare provider before you use this prefilled syringe for the first time.
- Gently pinch the area of cleaned skin around the injection site and hold that area firmly until the injection is complete.
- Fully insert the needle at an angle between 45˚ and 90˚. Do not change the angle during the injection.
- Do not hold or push on the plunger while inserting the needle into the skin.
- Hold the prefilled syringe in place and inject all of the medicine by firmly pushing the plunger all the way down.
- Press the plunger all the way down until it stops to get the full dose. Push firmly on the plunger until the end of the injection.
- After the plunger has been fully pushed down and the full dose injected, slowly remove the thumb from the plunger before removing the syringe from the skin (see Figure N). This will make the needle retract inside the syringe.
- Caution: Do not remove the syringe from the skin before removing the thumb, as this could result in a needle stick injury.
- Dispose of the syringe in an FDA-approved sharps disposal container.
Andembry autoinjector
The autoinjector contains 1 dose and is for one-time use only. Do not try to reuse the same autoinjector.
Do not use the autoinjector if it has dropped, looks damaged, has cracks, or is leaking medicine. Throw away the autoinjector in an FDA-approved sharps bin.
To use the autoinjector:
- Remove the clear cap by pulling straight off (don't twist) and dispose in sharps container. Don't touch the gray needle shield or replace the cap.
- Immediately pinch cleaned skin at the injection site and place the autoinjector at a 90° angle.
- Press down firmly to start injection (first click), keep pressing as the yellow plunger moves through the viewing window (second click), then continue pressing for 5 more seconds after the second click to ensure the full dose.
- Remove at a 90° angle - the gray shield will lock over the needle. Dispose entire autoinjector in an FDA-cleared sharps container. Don't reuse.
Dosing information
Dose of Andembry for HAE in patients 12 years and older
- Initial loading dose: 400 mg (two 200 mg injections) subcutaneously (SC)
- Monthly thereafter: 200 mg SC
What other drugs will affect Andembry?
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Andembry can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.
These are not all the possible drug interactions reported with Andembry. Talk to your healthcare provider about drug interactions.
Storage
Store Andembry prefilled syringes and autoinjectors in a refrigerator, between 36˚F to 46˚F (2˚C to 8˚C), in its original carton box until use, to protect it from light.
- Do not shake
- Do not freeze. If the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed.
- The refrigerated prefilled syringe may be used until the expiration date (EXP) printed on the label.
- Take the prefilled syringe out of the refrigerator 30 minutes before use, allowing it to reach room temperature.
- Do not put the prefilled syringe back in the refrigerator after it has reached room temperature.
What are the ingredients in Andembry?
Active ingredient: garadacimab-gxii
Inactive ingredients: arginine monohydrochloride, histidine, polysorbate 80, proline, water for injection.
Andembry injection is available as:
- 200 mg/1.2 mL solution in a single-dose prefilled autoinjector
- 200 mg/1.2 mL (167 mg/mL) solution in a single-dose prefilled syringe with a needle safety device.
Company
Andembry is manufactured by CSL Behring LLC, King of Prussia, PA 19406, for CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany.
References
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.