Tralokinumab-ldrm

What is Tralokinumab-ldrm?

• Tralokinumab-ldrm (Adbry) is an interleukin-13 antagonist used for the treatment of moderate-to-severe atopic dermatitis.

Tralokinumab 5L6Y

What are the uses of this medicine?

• Tralokinumab-ldrm (Adbry) is a prescription medicine used to treat adults 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.

How does this medicine work?

• Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).
• IL-13 is a naturally occurring cytokine of the Type 2 immune response.
• Tralokinumab-ldrm inhibits the bioactivity of IL-13 by blocking IL-13 interaction with IL-13Rα1/IL-4Rα receptor complex.
• Tralokinumab-ldrm inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• are allergic to tralokinumab or to any of the ingredients in ADBRY.

What drug interactions can this medicine cause?

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

Is this medicine FDA approved?

• It was approved for medical use in the United States in December 2021.

How should this medicine be used?

• Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with ADBRY.

Recommended dosage:

• 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.
• 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.

Administration:

• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard.
• 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.
• 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 more ADBRY than prescribed, call Poison Control at 1-800-222-1222.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg/mL solution in a single-dose prefilled syringe with needle guard.

This medicine is available in fallowing brand namesː

• ADBRY

What side effects can this medication cause?

The most common side effects of this medicine 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
• Eye problems

What special precautions should I follow?

• Hypersensitivity reactions, including anaphylaxis, and angioedema have occurred after administration of ADBRY. Discontinue ADBRY in the event of a hypersensitivity reaction.
• Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY. Patients should report new onset or worsening eye symptoms to their healthcare provider.
• It is unknown if ADBRY will influence the immune response against helminth infections by inhibiting IL-13 signaling. Treat patients with pre-existing helminth infections 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.
• ADBRY may alter a patient's immunity and increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ADBRY, complete all age appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no specific treatment for ADBRY overdose.
• In the event of overdosage, contact Poison Control (1-800-222-1222) for latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

Can this medicine be used in pregnancy?

• There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
• Human IgG antibodies are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus.

Can this medicine be used in children?

• The safety and effectiveness of ADBRY have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

• Manufactured by: LEO Pharma A/S Industriparken 55, Ballerup, Denmark
• Distributed by: LEO Pharma Inc., Madison, NJ, USA

What should I know about storage and disposal of this medication?

• ADBRY does not contain preservatives.
• Discard any unused product remaining in the prefilled syringe.
• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• If necessary, prefilled syringes may be kept at room temperature up to 30°C (86°F) for a maximum of 14 days in the original carton.
• Do not store above 30°C (86°F).
• If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the outer carton in the space provided. After removal from the refrigerator, ADBRY must be used within 14 days or discarded.
• Do not expose the prefilled syringe to heat or direct sunlight.
• Do not freeze.
• Do not shake.

• Dailymed label info on Tralokinumab-ldrm
• FDA Tralokinumab-ldrm

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