Tralokinumab

ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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.

Prior to ADBRY initiation, complete all age appropriate vaccinations as recommended by current immunization guidelines. Administer ADBRY by subcutaneous injection. In pediatric patients 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult. The recommended dosage of ADBRY.

ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY. Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, and angioedema have occurred after administration of ADBRY. Discontinue ADBRY in the event of a hypersensitivity reaction. Conjunctivitis and Keratitis: Patients should report new onset or worsening eye symptoms to their healthcare provider. Parasitic (Helminth) Infections: 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. Risk of Infection with Live Vaccines: Avoid use of live vaccines.

The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity Conjunctivitis and Keratitis Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. If necessary, ADBRY 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). Do not put ADBRY back in the refrigerator after reaching room temperature. 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 freeze. Do not shake.