Adbry

Adbry is used to treat moderate-to-severe atopic dermatitis (eczema) in adults and children 12 and older whose condition is not adequately controlled with topical prescription treatments or those treatments are not advisable. Adbry is administered subcutaneously every 2 weeks initially and can be used with or without topical corticosteroids.

Adbry (tralokinumab-ldrm) gained FDA approval on December 27, 2021. There is no generic or biosimilar.

See the detailed “Instructions for Use” that comes with Adbry for information on how to prepare and inject Adbry and how to properly store and throw away (dispose of) used Adbry prefilled syringes and autoinjectors.

• Use Adbry exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much Adbry to inject and when to inject it.
• Adbry comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
• Adbry is given as an injection under the skin (subcutaneous injection).

If your healthcare provider 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 healthcare provider.
• In children 12 years of age and older, it is recommended that Adbry be given by or under the supervision of an adult.

Your healthcare provider may prescribe other medicines to use with Adbry. Use the other prescribed medicines exactly as your healthcare provider tells you to.

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
• are breastfeeding or plan to breastfeed.

Pregnancy

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 duringpregnancy. 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/

Breastfeeding

It is not known whether Adbry passes into your breast milk and if it can harm your baby.

Common Side Effects

The most common side effects of Adbry are:

• 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).

Serious Side Effects and Warnings

Adbry can cause the following serious side effects.

Allergic reactions

Allergic reactions, including anaphylaxis and angioedema, have occurred after administration of Adbry. Do not use Adbry if you are allergic to tralokinumab, Adbry, or any of the ingredients in the injections. Stop taking Adbry and call your doctor immediately if you develop symptoms of an allergic reaction, such as:

• Breathing problems
• Swelling of the face, mouth, and tongue
• Hives
• Itching
• Fainting, dizziness, feeling lightheaded (low blood pressure)
• Skin rash.

Eye problems

Adbry may cause eye problems, such as conjunctivitis (an inflammation of the membrane that lines the eyelid and eyeball) or keratitis (corneal inflammation or ulcers). Tell your healthcare provider if you experience any new or worsening eye problems, such as eye pain or changes in vision.

Notes:

These are not all the possible side effects of Adbry. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Adbry (tralokinumab) works by targeting a specific protein in your immune system that plays a key role in allergic and inflammatory responses, called interleukin-13. Adbry binds directly to IL-13 and prevents it from attaching to its receptors on cells, which prevents activation of inflammatory pathways. This reduces atopic dermatitis symptoms, such as itching, redness, and skin thickening.

Adbry (tralokinumab-ldrm) belongs to the drug class called interleukin-13 inhibitors.

Adult Dose of Adbry for AD

Prefilled Syringe:

• Initial Loading Dose: 600 mg subcutaneously (4 x 150 mg injections)
• Every other week (every 2 weeks): 300 mg subcutaneously (2 x 150 mg injections)

Autoinjector:

• Initial Loading Dose: 600 mg subcutaneously (2 x 300 mg injections)
• Every other week (every 2 weeks): 300 mg subcutaneously (1 x 300 mg injection)

Note:

A dosage of 300 mg subcutaneously every 4 weeks may be considered for adults <100 kg who achieve clear or almost clear skin after 16 weeks of treatment.

Child 12+ Dose of Adbry for AD

Prefilled Syringe:

• Initial Loading Dose: 300 mg subcutaneously (2 x 150 mg injections)
• Every other week (every 2 weeks): 150 mg subcutaneously (1 x 150 mg injection)

In major clinical trials called ECZTRA, which studied over 1,500 patients, Adbry was compared to a placebo (inactive treatment).

• About one in four to one in three patients using Adbry achieved clear or nearly clear skin, compared to roughly one in eight patients on placebo.
• Around half of patients on Adbry saw their skin severity improve by 75% or more, while only about one in five to one in four placebo patients experienced this level of improvement.
• Nearly half of Adbry patients reported significant relief from itching, compared to about one in five patients on placebo.

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

If you inject too much Adbry, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Inject as soon as possible, then continue your regular schedule. Don't double-dose.

Avoid live vaccines while taking Adbry. Discuss your vaccination schedule with your doctor. Inactivated vaccines are generally safe. Before receiving Adbry, all your age-appropriate vaccinations should be up to date.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the product information for a full list of interactions.

Store Adbry in a refrigerator between 36°F and 46°F (2°C and 8°C).

• Store Adbry in the original carton and protect it from light until you are ready to use it.
• 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.

Adbry offers multiple support programs, including insurance navigation, free first doses within 48 hours for insured patients, no-cost medication for qualifying individuals with financial need, and copay assistance to reduce out-of-pocket expenses. Contact 1-844-MY-ADBRY weekdays 8 AM-8 PM ET for enrollment and assistance.

See Adbry Prices, Coupons, Copay Cards & Patient Assistance for more information.

Active Ingredient: tralokinumab-ldrm

Inactive ingredients: acetic acid, polysorbate 80, sodium acetate trihydrate, sodium chloride, and water forinjection.

Available as a prefilled syringe 150 mg/1 mL (ages 12+) and an autoinjector: 300 mg/2 mL (adults only).

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark and distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

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