ADBRY (Tralokinumab-ldrm) for Eczema

ADBRY is an injection available as a prescription used to treat adults with moderate-to-severe eczema that is not well controlled with prescription therapies used on the skin, or who cannot use topical therapies. It can be used with or without topical corticosteroids.

It is not known if ADBRY is safe to use in children.

ADBRY shouldn’t be used in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

The effectiveness of ADBRY was studied in 3 separate clinical trials of almost 2,000 adults.

In all 3 clinical trials where adults used Adbry every other week, more patients experienced relief at 4 months, and maintained relief through the end of the trials, either at 8 months or 12 months.

It also helped visibly improve the look and texture of skin at 4 months.

Before using ADBRY, tell your doctor about all your medical conditions, including if you:

• have eye problems

• have a parasitic (helminth) infection

• have received any vaccinations or planning to receive a vaccination. You shouldn’t receive a live vaccine if you are treated with ADBRY

• are pregnant or planning to become pregnant. It is not known if ADBRY can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known whether ADBRY can pass into your breast milk and if it can harm your baby.

• Tell your doctor about all of the medicines you take, including prescriptions, vitamins, over-the-counter medicines, and herbal supplements.

• Use ADBRY exactly as prescribed by your doctor.

• Your doctor will tell you how much ADBRY to inject and when to inject it.

• ADBRY comes as a single-dose (150 mg) prefilled syringe with a needle guard.

• ADBRY is given as an injection under the skin.

• If your doctor decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your doctor.

• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

• Your doctor may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your doctor tells you to.

• ADBRY can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

The recommended dosage of ADBRY is an initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks
may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment. Administer by subcutaneous injection.

The most common side effects of ADBRY include:

• eye and eyelid inflammation, including redness, swelling, and itching

• injection site reactions

• high count of a certain white blood cell (eosinophilia)

ADBRY can cause serious side effects, including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis: Stop using ADBRY and tell your doctor or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • swelling of the face, mouth, and tongue
  • hives
  • itching
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • skin rash

• Parasitic (Helminth) Infections: pre-existing helminth infections should be treated before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to anti-helminth treatment, discontinue treatment with ADBRY until the infection resolves.

• Eye problems: Tell your doctor if you have any worsening eye problems, including eye pain or changes in vision.

• Risk of Infection with Live Vaccines: Avoid the use of live vaccines

Active ingredient: tralokinumab-ldrm
Inactive ingredients: acetic acid, sodium acetate trihydrate, polysorbate 80, sodium chloride, and water for injection.