Tralokinumab-ldrm (Monograph)

Brand name: Adbry
Drug class: Immunomodulatory Agents

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Human IgG₄ monoclonal antibody that specifically binds to human interleukin-13 (IL-13).

Uses for Tralokinumab-ldrm

Atopic Dermatitis

Used for the treatment of moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years of age whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Can be used with or without topical corticosteroids.

Current guidelines from the American Academy of Dermatology (AAD) strongly recommend tralokinumab as one of several therapeutic options in adults with moderate to severe atopic dermatitis.

Tralokinumab-ldrm 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).

Other General Considerations

For the treatment of atopic dermatitis, tralokinumab can be administered with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (e.g., face, neck, intertriginous, and genital areas).

Administration

Sub-Q Administration

Administer by sub-Q injection. Available as single-use prefilled syringes and autoinjectors (containing 150 mg/mL).

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. Autoinjector is intended for adults only; prefilled syringe is intended for adults and pediatric patients ≥12 years of age. In pediatric patients ≥12 years of age, administration of the prefilled syringe under supervision of an adult is recommended.

Administer sub-Q injections into thigh or abdomen (avoid 2 inch area around the navel). Use thigh or abdomen for self-administration; may use upper arm if administered by a caregiver or clinician. Do not administer into areas where skin is tender, damaged, bruised, or scarred.

For adults taking the initial 600-mg loading dose, administer each of the four 150-mg injections using prefilled syringes or each of the two 300-mg injections using autoinjectors at different sites within the same body area. For subsequent 300-mg doses using the prefilled syringe, administer each of the two 150-mg injections at different sites within the same body area. For subsequent 300-mg doses using the autoinjector, administer a single 300-mg injection. Rotate the body area with each subsequent set of injections.

For pediatric patients ≥12 years of age, administer the initial 300-mg loading dose using prefilled syringes; administer each of the two 150-mg injections at different sites within the same body area. For subsequent 150-mg doses, use a prefilled syringe to administer a single injection, rotating the body area with each subsequent injection.

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

Dosage

Pediatric Patients

Atopic Dermatitis

Sub-Q

Pediatric patients 12 to 17 years of age: initial loading dose of 300 mg (two 150-mg injections via prefilled syringe), followed by maintenance dosage of 150 mg (one 150-mg injection via prefilled syringe) every other week.

Adults

Atopic Dermatitis

Sub-Q

Initial loading dose of 600 mg (four 150-mg injections via prefilled syringe or two 300-mg injections via autoinjector), followed by maintenance dosage of 300 mg (two 150-mg injections via prefilled syringe or one 300-mg injection via autoinjector) every other week.

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

Special Populations

Geriatric Patients

No specific dosage recommendations at this time.

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Cautions for Tralokinumab-ldrm

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 tralokinumab, 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 established for treatment of moderate to severe atopic dermatitis in pediatric patients 12-17 years of age whose disease is not adequately controlled with topical therapies or when those therapies are not advisable.

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

Drug	Interactions
Caffeine	No clinically important effect on AUC of caffeine (CYP1A2 substrate)
Metoprolol	No clinically important effect on AUC of metoprolol (CYP2D6 substrate)
Midazolam	No clinically important effect on AUC of midazolam (CYP3A4 substrate)
Omeprazole	No clinically important effect on AUC of omeprazole (CYP2C19 substrate)
Warfarin	No clinically important effect on AUC of warfarin (CYP2C9 substrate)

Tralokinumab-ldrm Pharmacokinetics

Absorption

Bioavailability

Approximately 76% following sub-Q administration.

Peak concentration achieved within 5–8 days.

Special Populations

Exposure decreases with increasing body weight.

Distribution

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

Prefilled syringes

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.

Prior to use, allow to reach room temperature (≥30 minutes) without removing the needle cover. Can be kept at room temperature (up to 30°C) for 14 days. Do not place prefilled syringe back in refrigerator after reaching room temperature.

Autoinjector

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.

Prior to use, allow to reach room temperature (≥45 minutes) without removing the needle cap. Can be kept at room temperature (up to 30°C) for 14 days. Do not place autoinjector back in refrigerator after reaching room temperature.

Actions

Human IgG₄ monoclonal antibody that specifically binds to human 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. For children ≥12 years of age, tralokinumab should be administered by or under supervision of an adult.
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 patients 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.
Inform 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.