Adbry
Pronunciation: ad-bree
Generic name: tralokinumab-ldrm
Dosage form: prefilled syringe for subcutaneous injection, single-dose autoinjector
Drug class: Interleukin inhibitors
What is Adbry?
Adbry (tralokinumab-ldrm) is an interleukin-13 (IL-13) inhibitor that may be used to treat adults and children aged 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with other topical prescription treatments or those treatments are not advised. Adbry can be used with or without topical corticosteroids and it is self-administered by subcutaneous (under the skin) injection using a prefilled syringe or single-dose autoinjector every other week after an initial loading dose.
Adbry works by specifically targeting IL-13, which is a protein that research has shown contributes to skin inflammation in eczema. Adbry binds to IL-13, preventing it from interacting with its receptor and releasing proinflammatory cytokines, chemokines, and IgE.
Adbry was FDA approved on December 27, 2021.
Adbry side effects
The most common side effects of Adbry affecting 1% or more people who take it include:
- 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).
Adbry can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using Adbry and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
- breathing problems
- swelling of the face, mouth, and tongue
- hives
- itching
- fainting, dizziness, feeling lightheaded (low blood pressure)
- skin rash.
- Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or vision changes.
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.
Warnings
Hypersensitivity reactions, including anaphylaxis, and angioedema have occurred after administration of Adbry. Do not use Adbry if you are allergic to tralokinumab or any of the ingredients. Stop taking Adbry and call your doctor immediately if you develop an allergic reaction.
May cause eye problems such as conjunctivitis (an inflammation of the membrane that lines the eyelid and eyeball) or keratitis (corneal ulcer). Report new onset or worsening eye symptoms to your healthcare provider.
Patients with a pre-existing helminth (parasitic worm) infection should be treated before starting Adbry. If a patient becomes infected during treatment and does not respond to anti-parasitic treatment, your healthcare provider may temporarily stop treatment until the infection resolves.
Avoid vaccination with live vaccines during treatment with Adbry.
Before taking this medicine
Before using Adbry, 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 Adbry
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known whether Adbry will harm your unborn baby. There is a pregnancy exposure registry for women who use Adbry 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 Adbry passes into your breast milk and if it can harm an unborn baby. Talk to your doctor if you are breastfeeding.
How is Adbry administered?
See the detailed Instructions for Use that come with your prescription for information on how to prepare and inject Adbry and how to properly store and throw away (dispose of) used prefilled syringes or autoinjectors.
- Use Adbry exactly as prescribed by your healthcare provider.
- Your healthcare provider will tell you how much Adbry to inject and when to inject it.
- Adbry comes as a single-dose (150 mg) prefilled syringe with a needle guard and a single-dose (300 mg/2 mL) autoinjector.
- Adbry is given as an injection under the skin (subcutaneous injection).
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 Adbry. Do not try to inject Adbry until you have been shown the right way by your healthcare provider.
- Inject the full dose of Adbry.
- Dispose of the used prefilled syringe or autoinjector in an FDA-approved sharps disposal container.
Recommended Adbry dosage
Adults 18 years and older
- Administer an initial loading dose of 600 mg
- Given as 4 prefilled syringes of 150 mg injections at different injection sites on the same day, or
- Given as 2 autoinjectors of 300 mg at different injection sites on the same day.
- The usual maintenance dose is 300 mg (two 150 mg injections [prefilled syringes} or one 300mg autoinjector given at different injection sites) administered every other week.
- 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.
Children aged 12 through 17 years
- Administer an initial loading dose of 300 mg.
- Given as 2 prefilled syringes of 150 mg injections at different injection sites on the same day.
- The usual maintenance dose is 150 mg administered every other week using a prefilled syringe.
Related/similar drugs
prednisone, Dupixent, Temovate, Lidex, Clobex, Clobevate
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 Adbry than prescribed, call Poison Control at 1-800-222-1222.
What other drugs will affect Adbry?
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 Adbry 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
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.
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
Leo Pharma Inc.
Adbry 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 Adbry.
Adbry (tralokinumab-ldrm) - LEO Pharma A/S
Formulation type | Strength |
---|---|
Autoinjector | 300 mg/2 mL |
Pre-Filled Syringe | 150 mg/mL |
Frequently asked questions
References
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- Drug class: interleukin inhibitors
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.