Tralokinumab
Pronunciation: TRAL-oh-KIN-ue-mab
Generic name: tralokinumab-ldrm
Brand names: Adbry, Adbry Autoinjector
Dosage form: prefilled syringe for subcutaneous injection (150 mg/1 mL), single-dose autoinjector (300 mg/2 mL)
Drug class: Interleukin inhibitors
What is tralokinumab?
Tralokinumab is used to treat moderate-to-severe eczema (atopic dermatitis) in adults and children aged 12 years and older that is not responding well to prescription topical eczema treatments or in those who cannot use topical treatments. It is self-administered subcutaneously by injection under the skin every other week. Tralokinumab can be used alone or with topical corticosteroids.
The autoinjector is for use only in adults. The prefilled syringe is for use in adults and children at least 12 years old.
Tralokinumab’s mechanism of action involves targeting interleukin 13 (IL-13), a protein that contributes to inflammation. Tralokinumab works by binding to IL-13, preventing it from interacting with its receptor and releasing proinflammatory cytokines, chemokines, and IgE. It belongs to the drug class called interleukin-13 (IL-13) inhibitors.
Tralokinumab gained FDA approval on December 27, 2021, under the brand name Adbry. There is no generic or biosimilar.
Side effects
The most common side effects of tralokinumab are:
- upper respiratory tract infections
- eye and eyelid inflammation, including redness, swelling, and itching
- injection site reactions
- high laboratory counts of a certain white blood cell (eosinophilia).
Serious side effects and warnings
Tralokinumab can cause the following serious side effects:
- Allergic reactions (hypersensitivity reactions), including anaphylaxis and angioedema, have occurred after administration of tralokinumab. Do not use tralokinumab if you are allergic to tralokinumab or any of the ingredients. Stop taking tralokinumab and call your doctor immediately if you develop symptoms of an allergic reaction, such as:
- breathing problems
- swelling of the face, mouth, and tongue
- hives
- itching
- fainting, dizziness, feeling lightheaded (low blood pressure)
- skin rash.
- Eye problems. May cause eye problems such as conjunctivitis (an inflammation of the membrane that lines the eyelid and eyeball) or keratitis (corneal ulcer). Tell your healthcare provider if you have any eye problems, including eye pain or vision changes.
Treat helminth (parasitic worm) infections before starting tralokinumab. During treatment, if you think you have worms, tell your healthcare provider immediately. If anti-worm treatment does not work, they may temporarily stop treatment until the infection resolves.
Avoid vaccination with live vaccines during treatment with tralokinumab.
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Opzelura
Opzelura (ruxolitinib) cream is used for the treatment of atopic dermatitis and vitiligo. Includes ...
Eucrisa
Eucrisa (crisaborole) is used to treat mild to moderate eczema (atopic dermatitis) Includes Eucrisa ...
Adbry
Adbry is used to treat moderate-to-severe atopic dermatitis (eczema) in adults and children aged 12 ...
Cibinqo
Cibinqo (abrocitinib) tablets are used for the treatment of moderate to severe eczema (atopic ...
Dupixent
Dupixent is used to treat eczema, eosinophilic or oral-corticosteroid-dependent asthma, chronic ...
Temovate
Temovate is used for atopic dermatitis, dermatitis, dermatological disorders, eczema, lichen ...
Lidex
Lidex is used for atopic dermatitis, dermatitis, eczema, psoriasis
Clobex
Clobex is used for atopic dermatitis, dermatitis, dermatological disorders, eczema, lichen planus ...
Olux
Olux is used for atopic dermatitis, dermatitis, dermatological disorders, eczema, lichen planus ...
Before taking this medicine
Before using tralokinumab, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not receive a live vaccine if you are treated with tralokinumab
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known whether tralokinumab will harm your unborn baby. There is a pregnancy exposure registry for women who use tralokinumab during pregnancy. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
Breastfeeding
It is not known whether tralokinumab passes into your breast milk and if it can harm an unborn baby. Talk to your doctor if you are breastfeeding.
How is tralokinumab administered?
See the detailed Instructions for Use that come with your prescription for information on how to prepare and inject tralokinumab and how to properly store and throw away (dispose of) used prefilled syringes or autoinjectors. Use tralokinumab exactly as prescribed by your healthcare provider.
- Tralokinumab is usually given every second week (every other week).
- Your healthcare provider will tell you how much tralokinumab to inject and when to inject it.
- Tralokinumab is injected under the skin in the stomach, thigh, or upper arm, usually once every 2 to 4 weeks. Your first dose may be given in 2 injections to receive the total dose.
- Do not inject within 2 inches of your navel (belly button), or areas where the skin is damaged, tender, bruised, or has scars. Do not inject into the same place twice in a row.
- Tralokinumab is available in a single-dose (150 mg) prefilled syringe with a needle guard and a single-dose (300 mg/2 mL) autoinjector.
- It is given as an injection under the skin (subcutaneous injection).
- Most people can be taught how to self-administer it.
- Throw away a prefilled syringe or autoinjector after one use, even if medicine is left inside. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
If your healthcare provider decides that you or a caregiver can give the injections, you or your caregiver should receive training on the right way to prepare and inject tralokinumab.
- Do not try to inject tralokinumab if your healthcare provider has not shown you how.
- Inject the full dose of tralokinumab.
- Dispose of the used prefilled syringe or autoinjector in an FDA-approved sharps disposal container.
Dosing information
Tralokinumab dosage for eczema in adults 18 years and older
Initial loading dose: 600 mg.
- A healthcare provider will administer this using 4 x 150 mg prefilled syringes or two 300 mg autoinjectors into different injection sites on the same day.
Maintenance dose: 300 mg every other week.
- This can be self-administered as 2 x 150 mg prefilled syringes or one 300 mg autoinjector into different injection sites on the same day.
- A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
Tralokinumab dosage for eczema in children aged 12 through 17 years
Initial loading dose: 300 mg.
- A healthcare provider will administer this using 2 x 150 mg prefilled syringes into different injection sites on the same day.
Maintenance dose: 150 mg every other week.
- This can be self-administered under supervision in older children or administered by a caregiver using a prefilled syringe.
What happens if I miss a dose?
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
What happens if I overdose?
If you inject more tralokinumab than prescribed, call Poison Control at 1-800-222-1222.
What other drugs will affect this medicine?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
See the product information for a full list of interactions.
Storage
Store unused prefilled syringes or autoinjectors in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect them from light.
- If necessary, prefilled syringes or autoinjectors may be kept at room temperature up to 30°C (86°F) for a maximum of 14 days in the original carton. Write the date of removal on the outer carton in the space provided.
- Do not store above 30°C (86°F). Do not put tralokinumab back in the refrigerator after they have reached room temperature. If not used within 14 days, then discard.
- Do not expose the prefilled syringe to heat or direct sunlight.
- Do not freeze. Do not shake.
- Discard any unused product remaining in the prefilled syringe.
Ingredients
Adbry prefilled syringes
Active: tralokinumab-ldrm 150 mg
Inactive: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5.
Contains no preservatives.
Available as a single-dose (150 mg/1 mL) prefilled syringe with a needle guard.
Adbry autoinjectors
Active: tralokinumab-ldrm 300 mg
Inactive: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.
Contains no preservatives.
Available as a single-dose (300 mg/2 mL) autoinjector.
Manufacturer
Tralokinumab is made by Leo Pharma Inc., under the brand Adbry. Leo Pharma’s headquarters are in Ballerup, Denmark.
Tralokinumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for tralokinumab.
Adbry (tralokinumab-ldrm) - LEO Pharma A/S
Formulation type | Strength |
---|---|
Autoinjector | 300 mg/2 mL |
Pre-Filled Syringe | 150 mg/mL |
View Adbry information in detail.
Frequently asked questions
References
More about tralokinumab
- Check interactions
- Compare alternatives
- Reviews (8)
- Side effects
- Dosage information
- During pregnancy
- Drug class: interleukin inhibitors
- Breastfeeding
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.