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) once, followed by 300 mg (given as two 150 mg injections) once every other week (Silverberg 2021; manufacturer's labeling). 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Adbry: Tralokinumab-ldrm 150 mg/mL (1 mL) [latex free; contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Adtralza: 150 mg/mL (1 mL) [contains polysorbate 80]
SUBQ: Allow prefilled syringe to reach room temperature for 30 minutes prior to use; do not heat prefilled pen in microwave, hot water, or direct sunlight. Do not shake syringes. Do not remove needle cover until immediately prior to injection. Administer SUBQ into the thigh or lower abdomen, avoiding areas within 2 inches of navel; caregiver may administer in upper arm. 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. 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 injections. Prefilled syringe does not contain preservatives; discard any unused product remaining in the prefilled syringe.
Atopic dermatitis, moderate to severe (alternative agent): Treatment of moderate to severe atopic dermatitis in adults 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.
Ocular disorders, including allergic conjunctivitis, conjunctivitis, and keratoconjunctivitis have been reported; atopic keratoconjunctivitis, keratitis, and ulcerative keratitis have also been reported rarely. 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)
|
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: Anaphylaxis, angioedema, hypersensitivity reaction
Immunologic: Antibody development
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.
• Ocular effects: Conjunctivitis and keratitis have been reported; advise patients to report any new-onset or worsening eye symptoms.
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.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Vaccines (Live): Tralokinumab may enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
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).
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. 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 and ocular adverse effects.
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.
Solution Prefilled Syringe (Adbry Subcutaneous)
150 mg/mL (per mL): $1,004.64
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