Adbry® & atopic dermatitis:
What you should know
Whether you’re already on Adbry or are considering treatment, find answers to frequently asked questions.
About atopic dermatitis (eczema)
Atopic dermatitis is a type of eczema. In fact, it’s the most common type, affecting over 16 million adults in the United States.
Eczema is a chronic skin disease that’s caused by an overactive immune response. When the immune response is triggered, it causes inflammation, and your skin can become itchy, red, and dry.
With eczema, the overactive immune response causes inflammation. So even when symptoms aren’t present on your skin, inflammation can still be happening under your skin.
Common symptoms of moderate-to-severe eczema include:
- Dry or scaly skin
- Darkening of the skin
- Itching
- Thickening of the skin
- Reddening of the skin
- Small raised bumps
Eczema can be exhausting and often unpredictable—appearing on different parts of the body. For adults, eczema most commonly appears on the neck, hands, arms, back of the knees, and inside the elbows.
While the exact cause of eczema is unknown, we do know that people with eczema have an overactive immune response and a weakened skin barrier that causes damage to the skin. That overactive immune response produces a number of proteins in the body—one of which is IL-13 (interleukin-13). IL-13 is a protein that sends signals that lead to inflammation in the skin.
Studies have shown that people with eczema have more IL-13 in their skin than people without eczema. It’s also been shown that the more IL-13 people have, the more severe their eczema.
When too much IL-13 is present in the skin, it leads to continued inflammation and unbearable itch. When you scratch your skin, the skin barrier weakens and becomes more damaged, allowing substances such as bacteria, allergens, and viruses to enter.
When the immune system detects these substances, the body produces more IL-13 in the skin, starting the vicious cycle again.
About Adbry
- ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
- It is not known if ADBRY is safe and effective in children under 12 years of age.
Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.
Adbry is not a cream, an ointment, or a pill. And it’s not a topical corticosteroid. It’s a biologic treatment that helps calm the inflammation that leads to the symptoms of eczema.
Adbry works inside the body to help get clearer skin and control the unbearable itch.
Adbry is the first biologic injection that specifically targets IL-13, one of the proteins in the immune system that contributes to skin inflammation in eczema.
A biologic is a type of medicine that is made from living organisms or components of living organisms.
Adbry works by helping to target and neutralize IL-13. When IL-13 is neutralized, it is unable to send signals that lead to eczema-related inflammation.
Adbry was studied in 3 separate clinical trials of almost 2,000 adults aged 18 and older with moderate-to-severe atopic dermatitis (eczema). Adults in the trials injected 2 prefilled syringes every other week.
TRIAL 1: 601 adults used Adbry; 197 used placebo
TRIAL 2: 577 adults used Adbry; 193 used placebo
TRIAL 3: 243 adults used Adbry + topical corticosteroids; 123 used placebo + topical corticosteroids
The safety of Adbry was studied in 5 clinical trials.
Adbry was proven to help clear skin and reduce itching at 4 months.
Yes. The Adbry autoinjector is available for adult patients. The autoinjector comes prefilled with one 300-mg dose. By pushing it against your skin, the device delivers the whole dose. When you’re done injecting, you can dispose of the empty device in a sharps container.
The autoinjector is not FDA approved for adolescent patients (ages 12-17).
Before using ADBRY, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations.
- are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby.
Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. - are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Adbry can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using Adbry and tell your healthcare professional or get emergency help right away if you get any of the following symptoms:
- breathing problems
- itching
- skin rash
- swelling of the face, mouth, and tongue
- fainting, dizziness, feeling lightheaded (low blood pressure)
- hives
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
The most common side effects of Adbry include:
- Upper respiratory tract infections
- Eye and eyelid inflammation, including redness, swelling, and itching
- Injection site reactions
- High count of a certain white blood cell (eosinophilia)
These are not all of the possible side effects of Adbry. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Injecting Adbry
For adults on the first day of treatment with Adbry, your healthcare professional will give you your initial (or loading) dose of either 2 autoinjectors or 4 prefilled syringes. This dose helps start to build up the medicine in your body.
Then, your healthcare professional will show you or your caregiver how to inject Adbry, just under your skin.
After you learn to inject Adbry and receive your loading dose, you will inject either 1 autoinjector or 2 prefilled syringes at home every other week.
After 4 months, if you have clear or almost clear skin and weigh under 220 lbs, your healthcare professional may determine if you should continue taking your dose every 2 weeks or if you can decrease to every 4 weeks. Use Adbry exactly as told by your healthcare professional.
Adbry is an injection given under the skin (also known as a subcutaneous injection).
Watch Emma’s injection routine with Adbry. She breaks down the steps and shows you how to properly inject your full maintenance dose of Adbry every other week.
Prefilled Syringe Training Video (Adolescent)
Prefilled Syringe
Training Video (Adults)
See how to use prefilled syringes
Your healthcare professional will show you or your caregiver how to inject Adbry under your skin.
After you learn to inject Adbry and receive your loading dose of 4 prefilled syringes, you will inject 2 prefilled syringes at home every other week for your maintenance dose. (NOTE: Autoinjectors require one injection for your whole maintenance dose.)
Always read the Instructions for Use that comes with your Adbry carton before self-injecting.
Adbry is an injection given under the skin (also known as a subcutaneous injection). Below, you can watch how to use the autoinjector. You’ll see step-by-step how to properly inject your full maintenance dose of Adbry every other week.
Autoinjector Training Video (Adults)
See how to use the autoinjector
Your healthcare professional will show you how to use the autoinjector.
After you learn to inject Adbry and receive your loading dose of 2 autoinjectors, you will self-inject with 1 autoinjector at home every other week for your maintenance dose.
Always read the Instructions for Use that comes with your Adbry carton before self-injecting.
IMPORTANT: Only adult patients can use the autoinjector. It cannot be used for adolescent patients (ages 12-17), as it does not have the correct dose for children.
- Store ADBRY in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Store ADBRY in the original carton and protect from light until you are ready to use them.
- ADBRY can be stored in the original carton at room temperature up to 86°F (30°C) for up to 14 days. If removed from the refrigerator, write down the date of removal on the back of the carton, and use ADBRY within 14 days. Throw away (dispose of) ADBRY in a sharps disposal container if left out of the refrigerator for more than 14 days.
- Do not freeze ADBRY. Do not use if they have been frozen.
- Do not shake ADBRY.
- Do not heat ADBRY.
- Do not put ADBRY into direct sunlight.
Keep ADBRY and all medicines out of the reach of children.
All used autoinjectors, syringes, and syringe covers should be thrown away in a puncture-resistant sharps container.
When your container is almost full, follow your local guidelines for disposal. Depending on where you live, there may be state or local laws to follow.
For more information about safe sharps disposal, and for specific information about disposal in the state where you live, visit the FDA’s website.
Adbry is a biologic injection that requires special shipping and handling by a specialty pharmacy. Specialty pharmacies are similar to local pharmacies in a number of ways. The major difference between the two is that a specialty pharmacy manages medicines that require special handling (e.g., require refrigeration).
Once you’ve been prescribed Adbry, your specialty pharmacy will process your prescription, confirm your shipping address over the phone, and then deliver the medicine to your home by mail.
Ask your healthcare professional about which specialty pharmacies are located near you.
The Adbry® Advocate® Program is here to help you through the process. Call 844-MY-ADBRY (844-692-3279) for help coordinating your Adbry shipment.
For information on how to prepare and inject Adbry, and how to properly store and throw away used Adbry Autoinjectors or prefilled syringes, download the Instructions for Use.
You can also watch this step-by-step Self-Injection Video.
Have questions about Adbry or the self-injection process? Those enrolled in the Adbry® Advocate® Program can receive virtual injection training upon request. Call 844-MY-ADBRY (844-692-3279) for more information.