Adbry

— THERAPEUTIC CATEGORIES —
  • Atopic dermatitis

Adbry Generic Name & Formulations

General Description

Tralokinumab-ldrm 150mg/mL; soln for SC inj; preservative-free.

Pharmacological Class

Interleukin-13 (IL-13) antagonist.

How Supplied

Single-dose prefilled syringe (w. needle guard)—2, 4

Manufacturer

Generic Availability

NO

Mechanism of Action

Tralokinumab-ldrm specifically binds to human IL-13 and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL13Rα2). It inhibits IL-13 induced responses including the release of proinflammatory cytokines, chemokines and IgE.

Adbry Indications

Indications

Moderate to severe atopic dermatitis in patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. May be used with or without topical corticosteroids.

Adbry Dosage and Administration

Adult

Give by SC inj into the thigh or abdomen (except for 2 inches around the navel); upper arm may be used if caregiver administers inj. Rotate inj sites. ≥18yrs: Initially 600mg (four 150mg inj), followed by 300mg (two 150mg inj) every other week. After 16 weeks, may consider 300mg every 4 weeks for patients weighing <100kg who achieve clear or almost clear skin. Concomitant topical calcineurin inhibitors: reserve for problem areas only (eg, face, neck, intertriginous, genital areas).

Children

<12yrs: not established. Give by SC inj into the thigh or abdomen (except for 2 inches around the navel); upper arm may be used if caregiver administers inj. Rotate inj sites. 12–17yrs: Initially 300mg (two 150mg inj), followed by 150mg every other week. Concomitant topical calcineurin inhibitors: reserve for problem areas only (eg, face, neck, intertriginous, genital areas).

Administration

Do not administer to tender, damaged, bruised, or scarred skin.

Adbry Contraindications

Not Applicable

Adbry Boxed Warnings

Not Applicable

Adbry Warnings/Precautions

Warnings/Precautions

Discontinue immediately if serious hypersensitivity reactions occur. New onset or worsening eye symptoms. Helminth infections: treat pre-existing infections prior to initiation; discontinue Adbry if become infected during therapy until infection resolves. Complete all vaccinations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

Adbry Pharmacokinetics

Absorption

Absolute bioavailability: ~76%. Time to maximum concentrations: 5 to 8 days.

Distribution

Volume of distribution: ~4.2 L.

Metabolism

Catabolic pathways.

Elimination

Half-life: 3 weeks.

Adbry Interactions

Interactions

Avoid concomitant live vaccines.

Adbry Adverse Reactions

Adverse Reactions

Upper respiratory tract infections, conjunctivitis, inj site reactions, eosinophilia; anaphylaxis, angioedema, keratitis.

Adbry Clinical Trials

See Literature

Adbry Note

Not Applicable

Adbry Patient Counseling

See Literature