tralokinumab (Rx)

Brand and Other Names:Adbry, tralokinumab-ldrm
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC injectable solution

  • 150mg/mL (single-dose prefilled syringe)

Atopic Dermatitis

Indicated for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

May use with or without topical corticosteroids (TCS)

600 mg SC initially, followed by 300 mg every other week

Patients weighing <100 kg treated for 16 weeks and who achieve clear or almost clear skin may consider 300 mg SC every 4 weeks

Dosage Modifications

Renal impairment

  • Mild or moderate: No dosage adjustment necessary
  • Severe: Pharmacokinetics are unknown

Hepatic impairment

  • Mild: No dosage adjustment necessary
  • Moderate or severe: Pharmacokinetics are unknown

Dosing Considerations

Before initiating

  • Complete all age-appropriate vaccinations as recommended by current immunization guidelines

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and tralokinumab

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              Serious - Use Alternative (18)

              • adenovirus types 4 and 7 live, oral

                tralokinumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • axicabtagene ciloleucel

                tralokinumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • BCG vaccine live

                tralokinumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • brexucabtagene autoleucel

                tralokinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                tralokinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • dengue vaccine

                tralokinumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • idecabtagene vicleucel

                tralokinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza virus vaccine quadrivalent, intranasal

                tralokinumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • lisocabtagene maraleucel

                tralokinumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • measles mumps and rubella vaccine, live

                tralokinumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • measles, mumps, rubella and varicella vaccine, live

                tralokinumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • rotavirus oral vaccine, live

                tralokinumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • smallpox (vaccinia) vaccine, live

                tralokinumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • tisagenlecleucel

                tralokinumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • typhoid vaccine live

                tralokinumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • varicella virus vaccine live

                tralokinumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • yellow fever vaccine

                tralokinumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              • zoster vaccine live

                tralokinumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.

              Monitor Closely (39)

              • anthrax vaccine adsorbed

                tralokinumab will decrease the level or effect of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • COVID-19 vaccine, mRNA-Pfizer

                tralokinumab will decrease the level or effect of COVID-19 vaccine, mRNA-Pfizer by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • COVID-19 vaccine, subunit-Novavax

                tralokinumab will decrease the level or effect of COVID-19 vaccine, subunit-Novavax by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • COVID-19 vaccine, viral vector-Janssen

                tralokinumab will decrease the level or effect of COVID-19 vaccine, viral vector-Janssen by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • haemophilus influenzae type b vaccine

                tralokinumab will decrease the level or effect of haemophilus influenzae type b vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • hepatitis A vaccine inactivated

                tralokinumab will decrease the level or effect of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • hepatitis a/b vaccine

                tralokinumab will decrease the level or effect of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • hepatitis b vaccine

                tralokinumab will decrease the level or effect of hepatitis b vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • HIV vaccine

                tralokinumab will decrease the level or effect of HIV vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • human papillomavirus vaccine, bivalent

                tralokinumab will decrease the level or effect of human papillomavirus vaccine, bivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • human papillomavirus vaccine, nonavalent

                tralokinumab will decrease the level or effect of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • human papillomavirus vaccine, quadrivalent

                tralokinumab will decrease the level or effect of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza A (H5N1) vaccine

                tralokinumab will decrease the level or effect of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine (H5N1), adjuvanted

                tralokinumab will decrease the level or effect of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine quadrivalent

                tralokinumab will decrease the level or effect of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine quadrivalent, adjuvanted

                tralokinumab will decrease the level or effect of influenza virus vaccine quadrivalent, adjuvanted by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine quadrivalent, cell-cultured

                tralokinumab will decrease the level or effect of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine quadrivalent, recombinant

                tralokinumab will decrease the level or effect of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine trivalent

                tralokinumab will decrease the level or effect of influenza virus vaccine trivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine trivalent, adjuvanted

                tralokinumab will decrease the level or effect of influenza virus vaccine trivalent, adjuvanted by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • influenza virus vaccine trivalent, recombinant

                tralokinumab will decrease the level or effect of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • Japanese encephalitis virus vaccine

                tralokinumab will decrease the level or effect of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine

                tralokinumab will decrease the level or effect of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • meningococcal A C Y and W-135 diphtheria conjugate vaccine

                tralokinumab will decrease the level or effect of meningococcal A C Y and W-135 diphtheria conjugate vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • meningococcal A C Y and W-135 polysaccharide vaccine combined

                tralokinumab will decrease the level or effect of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • meningococcal C and Y/haemophilus influenza type B vaccine

                tralokinumab will decrease the level or effect of meningococcal C and Y/haemophilus influenza type B vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • meningococcal group B vaccine

                tralokinumab will decrease the level or effect of meningococcal group B vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • pneumococcal vaccine 13-valent

                tralokinumab will decrease the level or effect of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • pneumococcal vaccine 15-valent

                tralokinumab will decrease the level or effect of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • pneumococcal vaccine 20-valent

                tralokinumab will decrease the level or effect of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • pneumococcal vaccine heptavalent

                tralokinumab will decrease the level or effect of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • pneumococcal vaccine polyvalent

                tralokinumab will decrease the level or effect of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • poliovirus vaccine inactivated

                tralokinumab will decrease the level or effect of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • rabies vaccine

                tralokinumab will decrease the level or effect of rabies vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • rabies vaccine chick embryo cell derived

                tralokinumab will decrease the level or effect of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • SARS-CoV-2 vaccine, inactivated

                tralokinumab will decrease the level or effect of SARS-CoV-2 vaccine, inactivated by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • tetanus toxoid adsorbed or fluid

                tralokinumab will decrease the level or effect of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • tick-borne encephalitis vaccine

                tralokinumab will decrease the level or effect of tick-borne encephalitis vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              • zoster vaccine recombinant

                tralokinumab will decrease the level or effect of zoster vaccine recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

              Minor (0)

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                Adverse Effects

                >10%

                Monotherapy

                • Upper respiratory tract infections (23.8%)

                Combo therapy with TCS

                • Upper respiratory tract infections (30%)
                • Conjunctivitis (13.6%)
                • Injection site reactions (11.1%)

                1-10%

                Monotherapy

                • Conjunctivitis (7.5%)
                • Injection site reactions (7.4%)
                • Eosinophilia (1.4%)

                Combo therapy with TCS

                • Eosinophilia (1.2%)
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                Warnings

                Contraindications

                Hypersensitivity to tralokinumab or any excipients in drug product

                Cautions

                Hypersensitivity reaction, including anaphylaxis and angioedema, have occurred; discontinue therapy if hypersensitivity reaction occurs

                Conjunctivitis and keratitis reported; report new onset or worsening eye symptoms to healthcare provider

                Treat patients with pre-existing helminth infections before initiating; if infection develops during treatment and is unresponsive to antihelminth therapy, discontinue treatment until infection resolves

                Drug interaction overview

                • Vaccinations
                  • Avoid use of live vaccines
                  • Tralokinumab may alter immunity and increase the risk of infection following administration of live vaccines
                  • Limited data are available regarding coadministration with non-live vaccines
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                Pregnancy & Lactation

                Pregnancy

                Limited data are available on use in pregnant females

                Human IgG antibodies are known to cross placental barrier; therefore, drug may be transmitted from mother to developing fetus

                Animal studies

                • In an enhanced prenatal and postnatal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after IV tralokinumab during organogenesis through parturition at doses up to 10x the maximum recommended human dose

                Lactation

                There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production

                Maternal IgG is present in breast milk

                Effects of local gastrointestinal exposure and limited systemic exposure on breastfed infants are unknown

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Interleukin-13 (IL-13) antagonist; human IgG4 monoclonal antibody that binds to human IL-13 and inhibits its interaction with IL-13 receptor alpha-1 and alpha-2 subunits, therefore, blocking IL-13–induced responses (eg, release of proinflammatory cytokines, chemokines, IgE)

                Absorption

                Peak plasma time: 5-8 days

                Steady-state trough concentration: 98-101.4 mcg/mL

                Steady-state reached by week 16 following a 600-mg initial dose and 300 mg every other week

                Bioavailability: 76%

                Distribution

                Vd: 4.2 L

                Metabolism

                Expected to be metabolized into small peptides by catabolic pathways

                Elimination

                Clearance: 0.149 L/day

                Half-life: 3 weeks

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                Administration

                SC Preparation

                Remove prefilled syringe from refrigerator and allow to reach room temperature (30 minutes) without removing needle cap

                Once removed from refrigerator, prefilled syringe may be kept at room temperature (≤25ºC [77ºF]) for up to 14 days

                Visually inspect for particulate matter and discoloration before administering; solution is clear-to-opalescent, colorless-to-pale yellow solution; discard if liquid contains visible particulate matter, is discolored, or is cloudy

                SC Administration

                Administer SC only

                Intended for use under supervision of a healthcare provider; patients may self-inject after training in SC injection technique

                Provide proper training on preparation and administration to patients and caregivers

                Initial 600-mg dose: Administer each of the four 150-mg injections at different injection sites within the same body area

                Subsequent 300-mg doses: Administer two 150-mg injections at different injection sites within the same body area

                Site of administration: Thigh, abdomen (except for 2 inches [5 cm] around the navel), or upper arm if a caregiver is administering

                Rotate body area with each subsequent set of injections; do NOT inject into skin that is tender, damaged, bruised, or scarred

                Does not contain preservatives; discard any unused product remaining in prefilled syringe

                Missed dose: Administer as soon as possible; resume dosing at regularly schedule time

                Concomitant topical therapies

                • May use with or without TCS
                • Topical calcineurin inhibitors should be reserved for problem areas (eg, face, neck,intertriginous and genital areas) only

                Storage

                Prefilled syringes

                • Does not contain preservatives; discard any unused product remaining in prefilled syringe
                • Refrigerate at 2-8ºC (36-46ºF) in the original carton to protect from light
                • If necessary, may be kept at room temperature ≤25ºC (77ºF) for up to 14 days in the original carton
                • If carton needs to be removed permanently from refrigerator, record date of removal on outer carton in space provided
                • After removal from refrigerator, use within 14 days or discard
                • Do not expose to heat or direct sunlight
                • Do not freeze; do not shake
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.