Version July 2025
Atopic dermatitis, moderate to severe (alternative agent):
Note: Treat any preexisting helminth infections and complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines during therapy. Tralokinumab may be administered in combination with or without topical corticosteroids.
SUBQ: 600 mg (given as four 150 mg injections [prefilled syringe] or two 300 mg injections [autoinjector]) once, followed by 300 mg (given as two 150 mg injections [prefilled syringe] or one 300 mg injection [autoinjector]) once every other week (Ref). In patients with body weight <100 kg who achieve clear or almost clear skin after 16 weeks of therapy, may reduce dosage to 300 mg every 4 weeks.
Missed doses: Administer missed dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Tralokinumab: Pediatric drug information")
Atopic dermatitis, moderate to severe:
Note: Treat any preexisting helminth infections and complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines during therapy. Tralokinumab may be administered in combination with topical corticosteroids or topical calcineurin inhibitors; reserve calcineurin inhibitors for problem areas such as the face, neck, intertriginous, and genital areas. Some doses may require more than 1 injection to achieve dose.
Children ≥12 years and Adolescents <18 years:
Loading dose: Prefilled syringe: SUBQ: 300 mg (administer two 150 mg injections) once.
Maintenance dose: Prefilled syringe: SUBQ: 150 mg every other week.
Adolescents ≥18 years:
Loading dose:
Autoinjector: SUBQ: 600 mg (administer two 300 mg injections) once.
Prefilled syringes: SUBQ: 600 mg (administer four 150 mg injections) once.
Maintenance dose: Note: In patients ≥18 years with body weight <100 kg who achieve clear or almost clear skin after 16 weeks of therapy, reducing dose to 300 mg every 4 weeks may be considered.
Autoinjector: SUBQ: 300 mg every other week.
Prefilled syringe: SUBQ: 300 mg (administer two 150 mg injections) every other week.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Ocular disorders, including allergic conjunctivitis, conjunctivitis, keratoconjunctivitis, atopic keratoconjunctivitis, keratitis, and ulcerative keratitis have been reported. In clinical trials, most cases were mild or moderate and resolution occurred in ~75% of cases despite continued treatment with tralokinumab (Ref).
Mechanism: Unknown; tralokinumab inhibits IL-13 signaling, which may lead to decreased intraepithelial conjunctival goblet cells and lower mucus production (Ref).
Onset: Delayed; median time to first episode of conjunctivitis in clinical trials: 50 days (Ref).
Risk factors:
• Severe atopic dermatitis at baseline (Ref)
• History of allergic conjunctivitis/atopic keratoconjunctivitis (Ref)
• Number of atopic comorbidities (ie, asthma, food allergy, hay fever) (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Respiratory: Upper respiratory tract infection (24%)
1% to 10%:
Hematologic & oncologic: Eosinophilia (1%)
Local: Injection-site reaction (7%)
Ophthalmic: Conjunctivitis (6% to 9%, including allergic conjunctivitis) (table 1), keratoconjunctivitis (≤2%) (table 2)
|
Drug (Tralokinumab) |
Placebo |
Dose |
Number of Patients (Tralokinumab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|---|
|
9% |
N/A |
300 mg every other week |
1,180 |
N/A |
Maintenance treatment: Weeks 16 to 52 |
|
8% |
3% |
600 mg at week 0, followed by 300 mg every other week |
1,180 |
388 |
Initial treatment: Weeks 1 to 16; including allergic conjunctivitis |
|
6% |
N/A |
300 mg every 4 weeks |
1,180 |
N/A |
Maintenance treatment: Weeks 16 to 52 |
|
Drug (Tralokinumab) |
Placebo |
Dose |
Number of Patients (Tralokinumab) |
Comments |
|---|---|---|---|---|
|
2% |
N/A |
300 mg every other week |
1,180 |
Maintenance treatment: Weeks 16 to 52 |
|
0.3% |
0% |
N/A |
N/A |
N/A |
<1%: Ophthalmic: Keratitis (including atopic keratoconjunctivitis and ulcerative keratitis) (table 3)
|
Drug (Tralokinumab) |
Placebo |
Dose |
Number of Patients (Tralokinumab) |
Comments |
|---|---|---|---|---|
|
0.6% |
N/A |
300 mg every other week |
1,180 |
Maintenance treatment: Weeks 16 to 52 |
|
0.5% |
0% |
N/A |
N/A |
Including keratoconjunctivitis |
|
0.2% |
0.2% |
N/A |
N/A |
Including ulcerative keratitis |
Frequency not defined:
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis and angioedema)
Immunologic: Antibody development
Postmarketing: Dermatologic: Psoriasis (Balakirski 2023)
Hypersensitivity to tralokinumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. If signs/symptoms of a serious hypersensitivity reaction develop, discontinue use immediately and initiate appropriate treatment.
Disease-related concerns:
• Helminth infections: It is unknown if administration of tralokinumab will influence a patient's response against parasitic infections; patients with known helminth infections were not studied. Treat any preexisting helminth infections prior to initiating tralokinumab. In patients who become infected during treatment and do not respond to antihelminth therapy, discontinue tralokinumab until the infection resolves.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines during therapy. Limited data regarding coadministration with nonlive vaccines suggest similar antibody responses in tralokinumab-treated and placebo-treated patients.
• Immunogenicity: Tralokinumab antibodies, including neutralizing antibodies, may develop.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Adbry: Tralokinumab-ldrm 300 mg/2 mL (2 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Adbry: Tralokinumab-ldrm 150 mg/mL (1 mL) [latex free; contains polysorbate 80]
No
Solution Auto-injector (Adbry Subcutaneous)
300 mg/2 mL (per mL): $1,220.81
Solution Prefilled Syringe (Adbry Subcutaneous)
150 mg/mL (per mL): $1,220.81
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Adtralza: Tralokinumab-ldrm 300 mg/2 mL (2 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Adtralza: Tralokinumab-ldrm 150 mg/mL (1 mL) [contains polysorbate 80]
SUBQ: Administer SUBQ into the thigh or lower abdomen, avoiding areas within 2 inches of navel; caregiver may administer in upper arm. For each set of injections, ensure each injection is at least 1 inch (3 cm) from the prior injection site and within the same body area; rotate body areas with each subsequent set of injection(s). Do not administer into bruised, damaged, scarred, or tender skin. Do not shake. Does not contain preservatives; discard any unused product remaining in the prefilled syringe or autoinjector. Following proper training by a health care provider, autoinjector or prefilled syringes may be self-administered or administered by a caregiver May use with topical corticosteroids and topical calcineurin inhibitors; however, reserve concurrent use of topical calcineurin inhibitors to problem areas (eg, face, genital, intertriginous, neck areas).
Autoinjector: Allow to reach room temperature for at least 45 minutes prior to use; do not heat autoinjector in microwave, hot water, or direct sunlight. Do not remove cap until immediately prior to injection. Place needle guard flat against skin at a 90-degree angle; viewing window should be visible. Hold autoinjector firmly against skin and press button. A loud click is heard when injection has begun; continue to hold autoinjector against skin until second click is heard (may take up to 15 seconds) and for 5 seconds following second click. Following second click, lift autoinjector straight away from injection site. Do not rub injection site after administration; a dry cotton ball or gauze pad may be placed over injection area for a few seconds. Administer the 600 mg dose as a set of two 300 mg injections and the 300 mg dose as one 300 mg injection.
Prefilled syringes: Allow to reach room temperature for at least 30 minutes prior to use; do not heat prefilled pen in microwave, hot water, or direct sunlight. Do not remove needle cover until immediately prior to injection. Insert needle completely into skin at about a 45-degree angle. Administer the 600 mg dose as a set of four 150 mg injections and the 300 mg dose as a set of two 150 mg injections.
Note: Patients ≥12 years of age may self-administer prefilled syringes under adult supervision after proper training, or doses may be administered by trained caregivers. Patients ≥18 years may self-administer autoinjectors after proper training.
SUBQ: Administer SUBQ into the thigh or lower abdomen, avoiding areas within 2 inches of navel; caregiver may administer in upper arm. Do not administer into skin that is tender, damaged, bruised, or scarred. If the dose requires more than one injection, ensure each injection is at least 1 inch from the prior injection site and within the same body area; rotate body areas with each subsequent set of injections.
Prefilled syringes: For use in ages ≥12 years. Determine the number of prefilled syringe(s) needed for dose; each syringe contains 150 mg. Remove prefilled syringe(s) required for the dose from the refrigerator and allow to reach room temperature for 30 minutes prior to use; do not heat in microwave, hot water, or direct sunlight. Do not shake syringes. Gently pinch skin at injection site, insert needle at a 45-degree angle; slowly and steadily push plunger rod until it completely stops and the syringe is empty. Prefilled syringes do not contain preservatives; discard any unused product remaining in the prefilled syringe.
Autoinjector: For use in ages ≥18 years. Determine the number of autoinjector(s) needed for dose; each autoinjector contains 300 mg. Remove autoinjector(s) required for the dose from the refrigerator and allow to reach room temperature for 45 minutes prior to use; do not heat in microwave, hot water, or direct sunlight. Do not shake syringes. Gently pinch skin at injection site, hold autoinjector firmly against clean skin at a 90-degree angle, and press button. A loud click is heard when injection has begun; continue to hold autoinjector against skin through the second click (may take up to 15 seconds) and for 5 seconds following second click; then lift autoinjector from injection site. Autoinjectors do not contain preservatives; discard any unused product remaining in the device.
Missed doses: Administer missed dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Atopic dermatitis, moderate to severe (alternative agent): 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.
Adbry may be confused with Abilify, Advair. Tralokinumab may be confused with trastuzumab.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vaccines (Live): Tralokinumab may increase adverse/toxic effects of Vaccines (Live). Risk X: Avoid
Tralokinumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to tralokinumab is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (877-311-8972 or https://mothertobaby.org/studies). Patients may also enroll themselves.
It is not known if tralokinumab is present in breast milk.
Tralokinumab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor for signs/symptoms of hypersensitivity reactions, ocular adverse effects (conjunctivitis, keratitis), and signs of infections (particularly parasitic [helminth] infections).
Tralokinumab is a human IgG4 monoclonal antibody that binds to interleukin-13 (IL-13) and blocks its interaction with the IL-13 receptor α1 and α2 subunits. Tralokinumab inhibits the bioactivity of IL-13 (a naturally occurring cytokine of the Type 2 immune response), and prevents the release of proinflammatory cytokines, chemokines, and IgE.
Distribution: Vd: ~4.2 L.
Metabolism: Metabolized into small peptides by catabolic pathways.
Bioavailability: ~76%.
Half-life elimination: 3 weeks.
Time to peak: 5 to 8 days.
Excretion: Clearance: 0.149 L/day.
Body weight: Tralokinumab exposure decreases with increasing body weight. At a dosage of 300 mg every 4 weeks, the median AUC of patients weighing >100 kg is expected to be 1.46 times lower than patients weighing <100 kg.
