Andembry

Andembry is used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years and older. It is administered once a month by subcutaneous injection, which patients or caregivers can be trained to self-administer at home.

Andembry (garadacimab) is an activated Factor XII (FXIIa) inhibitor that works by inhibiting activated Factor XII, the first step in the contact activation pathway, preventing prekallikrein from converting to kallikrein, reducing bradykinin generation, and stopping the inflammatory cascade responsible for HAE attacks.

Andembry (aradacimab-gxii) gained FDA approval on June 16, 2025, based on the Phase 3 VANGUARD clinical trial (NCT04656418), which showed 62% of patients remained completely attack-free, with overall attack rates reduced by 99% (median) and 89% (mean) compared with placebo, including attacks requiring on-demand therapy and moderate-to-severe episodes.

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 a 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 the 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 of the entire autoinjector in an FDA-cleared sharps container. Don't reuse.

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 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.

Dose of Andembry for Prevention of HAE Attacks (Adults and Children 12+)

• Initial loading dose: 400 mg (two 200 mg injections) subcutaneously (SC)
• Monthly thereafter: 200 mg subcutaneously once a month.

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.

Store prefilled syringes and autoinjectors in the refrigerator (36–46°F / 2–8°C) in the original carton to protect from light.

• Do not shake or freeze. If frozen, discard even if thawed.
• Refrigerated product may be used until the expiry date on the label.
• Remove from the refrigerator 30 minutes before use to reach room temperature; do not return to the refrigerator once warmed.

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.

Andembry is manufactured by CSL Behring LLC, King of Prussia, PA 19406, for CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany.