Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
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, adjuvanted-Novavax
tralokinumab will decrease the level or effect of COVID-19 vaccine, adjuvanted-Novavax 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, 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)
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%)
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
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.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
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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Formulary
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.
