Tralokinumab (Monograph)

Brand name: Adbry
Drug class: Skin and Mucous Membrane Agents, Miscellaneous

Medically reviewed by Drugs.com on Jul 28, 2023. Written by ASHP.

Introduction

Interleukin-13 antagonist; skin or mucous membrane agent.

Uses for Tralokinumab

Atopic Dermatitis

Used for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Tralokinumab-ldrm can be used with or without topical corticosteroids.

Current U.S. guidelines do not address the use of tralokinumab for atopic dermatitis.

Tralokinumab Dosage and Administration

General

Pretreatment Screening

• Ensure that patients receive all recommended vaccinations before initiating treatment with tralokinumab.

• Treat patients with pre-existing helminth infections before initiating treatment.

Patient Monitoring

• Monitor for symptoms of keratitis or conjunctivitis (e.g., redness, eye pain, or changes in vision).

Administration

Sub-Q Administration

Available as single-use prefilled syringes (containing 150 mg/mL). Should appear as a clear to opalescent, colorless to pale yellow solution.

Administer by sub-Q injection into thigh or abdomen; do not make abdominal injections within 2 inches of the navel. Use thigh or abdomen for self-administration; may use upper arm if administered by a caregiver or clinician. Do not make injections into areas where skin is tender, damaged, bruised, or scarred.

For initial dose, administer each of the 4 injections at different sites within the same body area. For subsequent doses, administer each of the 2 injections at different sites within the same body area. Rotate the body area with each subsequent set of injections.

Intended for use under supervision of a clinician, but may be self-administered if clinician determines that patient and/or caregiver is competent to prepare and safely administer drug after appropriate training.

Dosage

Adults

Atopic Dermatitis

Sub-Q

Initial dose: 600 mg (four 150-mg injections); maintenance dose: 300 mg (two 150-mg injections) every other week.

After 16 weeks, may consider reducing dosage to 300 mg every 4 weeks in patients < 100 kg who achieve clear or almost clear skin.

If a dose is missed, administer missed dose as soon as possible and resume dosing at regularly scheduled interval.

Prescribing Limits

Special Populations

No specific dosage recommendations at this time.

No specific dosage recommendations at this time.

No specific dosage recommendations at this time.

Cautions for Tralokinumab

Contraindications

Known hypersensitivity to tralokinumab or any component of the formulation.

Warnings/Precautions

Hypersensitivity

Hypersensitivity reactions including anaphylaxis and angioedema reported with tralokinumab-ldrm.

If serious hypersensitivity reaction occurs, discontinue immediately and initiate appropriate therapy.

Conjunctivitis and Keratitis

Conjunctivitis and keratitis more frequent in subjects who received tralokinumab-ldrm; conjunctivitis most frequently reported. Most subjects with conjunctivitis or keratitis recovered or were recovering during treatment period.

Advise patients to report new onset or worsening eye symptoms.

Parasitic (Helminth) Infections

Patients with known helminth infections excluded from clinical studies. Unknown if tralokinumab will influence immune response against helminth infections by inhibiting IL-13 signaling.

Treat patients with pre-existing helminth infections before initiating treatment. If patients become infected while receiving tralokinumab and do not respond to antihelminth treatment, discontinue tralokinumab until infection resolves.

Risk of Infection with Live Vaccines

May alter immunity and increase risk of infection following administration of live vaccines. Prior to initiating tralokinuimab, complete all age-appropriate vaccinations according to current guidelines. Avoid live vaccines in patients treated with tralokinumab. Limited data are available regarding coadministration with non-live vaccines.

Immunogenicity

Development of antibodies observed in 4.6% of treated patients in clinical studies; no substantial impact on efficacy, safety, and or tolerability. Neutralizing antibodies detected in 1% of treated patients.

Specific Populations

Pregnancy

Data in pregnant women inadequate to establish risk of adverse developmental outcomes. Potential for fetal exposure since human IgG crosses the placenta.

No maternal or developmental toxicity observed in studies of pregnant animals receiving IV tralokinumab-ldrm at doses above maximum recommended human dose.

Pregnancy registry available at 877-311-8972 or [Web]

Lactation

Not known whether tralokinumab distributes into human milk, affects milk production, or affects breast-fed infants. Maternal IgG is present in breast milk.

Effects of local GI and limited systemic exposure in the breast-fed infant are unknown. Consider benefits of breast-feeding and importance of the drug to woman; also consider any potential adverse effects on breast-fed infant from drug or underlying maternal condition.

Pediatric Use

Safety and effectiveness not established in pediatric patients.

Geriatric Use

Insufficient numbers of subjects ≥65 years enrolled in clinical studies to determine whether they respond differently from younger subjects.

Hepatic Impairment

No substantial difference in pharmacokinetics in mild hepatic impairment. Effect of moderate to severe hepatic impairment on pharmacokinetics is unknown.

Renal Impairment

No substantial difference in pharmacokinetics in mild to moderate renal impairment. Effect of severe renal impairment on pharmacokinetics is unknown.

Common Adverse Effects

Most common adverse reactions (≥1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, eosinophilia.

Drug Interactions

Vaccines

Avoid live vaccines. No data available regarding response to live or inactivated vaccines in patients receiving tralokinumab.

Specific Drugs

Tralokinumab Pharmacokinetics

Absorption

Bioavailability

Approximately 76% following sub-Q administration.

Peak concentration achieved within 5–8 days. Steady-state concentrations attained by week 16 following 600-mg starting dose and 300 mg every other week.

Concentrations dose-proportional over range up to 2100 mg for a 70 kg patient (30 mg/kg IV).

Distribution

Special Populations

Exposure decreases with increasing body weight.

Extent

Not known whether distributed into human milk.

Elimination

Metabolism

Metabolic pathway not characterized. Expected to be degraded into small peptides via catabolic pathway.

Half-life

3 weeks.

Special Populations

Age, sex, mild to moderate renal impairment, or mild hepatic impairment does not substantially alter pharmacokinetics .

Pharmacokinetics not formally studied in severe renal impairment or moderate to severe hepatic impairment.

Stability

Storage

Parenteral

Injection, for subcutaneous use.

2–8°C; do not freeze or expose to heat or direct sunlight. Do not shake. Store in original carton to protect from light until use. Can be kept at room temperature (up to 30°C) for 14 days in original carton.

Actions

• 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).

• Inhibits bioactivity of IL-13 by blocking IL-13 interaction with IL-13Rα1/IL-4Rα receptor complex.

• Inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines, and IgE.

Advice to Patients

• Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare provider for proper training in subcutaneous injection technique.

• Instruct patients or caregivers to inject the full dose of tralokinumab-ldrm.

• Instruct patients or caregivers to follow sharps disposal recommendations.

• Advise patients to discontinue tralokinumab-ldrm and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.

• Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop.

• Advise patients that tralokinumab-ldrm may increase the risk of infection following administration of live vaccines and that vaccination with live vaccines is not recommended during tralokinumab-ldrm treatment. Instruct patients to inform the healthcare provider that they are taking tralokinumab-ldrm prior to a potential vaccination.

• Advise women to inform clinicians if they are or plan to become pregnant or plan to breast-feed. Encourage pregnant women to enroll in a pregnancy registry (877-311-8972 or at [Web]) if exposed to tralokinumab-ldrm.

• Advise patient to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

• What are the most common skin conditions? (with photos)

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