This website contains information about Adtralza^®, a medicine for the treatment of moderate to severe atopic dermatitis (also know as atopic eczema) in adults and adolescents 12 years and older. Here you can read about how Adtralza^® works, what you need to know before you start taking it, information about possible side effects and a step-by-step guide on how to use it. You’ll also find answers to frequently asked questions about Adtralza^®.

Before you start your treatment with Adtralza^®, please take the time to read the patient information leaflet (PIL) that comes in the pack. This website does not replace the PIL.

For residents of the UK, the PIL is available online via the following links for the Adtralza^® pre-filled pen and pre-filled syringe.
For residents of the Republic of Ireland, the PIL is available online via the following links for the Adtralza^® pre-filled pen and pre-filled syringe.

Always refer to the PIL for full details and use Adtralza^® exactly as your dermatology team have told you. If you have any questions, ask a member of your dermatology team.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Side effects reporting information can be found at the bottom of this page.

What is Adtralza^®?

Adtralza^® contains the active substance tralokinumab.

Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays a major role in causing the symptoms of atopic dermatitis.

Adtralza^® is an injectable biologic medicine. This is a type of medicine made from proteins which work with your immune system to block some of the processes that cause inflammation and other symptoms of atopic dermatitis.^1,2

How Adtralza^® works

Adtralza^® is used to treat adults and adolescents 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. Adtralza^® may be used with eczema medicines that you apply to the skin or it may be used on its own. Using Adtralza^® for atopic dermatitis can improve your eczema and reduce the related itching and skin pain.

In people with atopic dermatitis, an overactive immune system produces too much of the protein IL-13.^3,4 When IL-13 is activated, it can lead to inflammation, itch and damage to the skin barrier.^3,4

Adtralza^® works by blocking the action of IL-13.^1,2 This stops IL-13 in the body from sending the signals that start the inflammation process, which can then help to calm the underlying inflammation and symptoms of atopic dermatitis.^1,2

What to expect from Adtralza^® treatment

Adtralza^® can help improve the appearance of skin^5,6 and some of the troublesome symptoms of atopic dermatitis such as itch and sleep disturbance in some patients.^5,7

Everyone is different and results from Adtralza^® treatment may vary from patient to patient. Some patients may see results after a few weeks, some may not see results at all, and others may need longer than a few weeks.^5-7

Clinical research involving 252 patients using Adtralza^® (with steroid cream as needed) found that 56% achieved the target of a 75% reduction in the severity of their atopic dermatitis after 16 weeks; and when they continued on Adtralza^®, 70% of patients managed to achieve that target by 32 weeks.⁷

Your care team will know more about your specific circumstances, and will be able to give you more information about what to expect.

Possible side effects

Like all medicines, Adtralza^® can cause side effects, although not everybody gets them.

Adtralza^® can cause serious side effects, including allergic (hypersensitivity) reactions such as anaphylaxis; the signs may include:

breathing problems
swelling of the face, mouth and tongue
fainting, dizziness, feeling lightheaded (low blood pressure)
hives
itching
skin rash

Stop using Adtralza^® and tell your doctor or get medical help immediately if you notice any signs of allergic reaction.

Other side effects

Very common (may affect more than 1 in 10 people):

Upper respiratory tract infections (i.e. common cold and sore throat).

Common (may affect up to 1 in 10 people):

Eye redness and itching.
Eye infection.
Injection site reactions (i.e. redness, swelling).

Uncommon (may affect up to 1 in 100 people):

Eye inflammation which may cause eye pain or decreased vision.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. You can also report any side effects to the relevant health authorities in the UK or Ireland. Full side effects reporting information can be found at the bottom of this page.

References:

1. Adtralza^® SPC. 2. Silverberg JI and Kantor R. Dermatol Clin 2017;35:327–334. 3. Bieber T. Allergy 2020;75:54–62. 4. Kim BE, et al. Clin Immunol 2008;126(3):332–337. 5. Wollenberg A, et al. Br J Dermatol 2021;184(3):437–449. 6. Silverberg JI, et al. Br J Dermatol 2021;184(3):450–463. 7. Silverberg JI, et al. Am J Clin Dermatol 2022; 23:547-559.

Reporting side effects

Adtralza®▼ (tralokinumab) is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet.

For the United Kingdom

You can also report side effects via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App Store.

For the Republic of Ireland

The Health Products Regulatory Authority (HPRA) monitors the safety and quality of all medicines available in Ireland. Should you wish, you can also report any suspected side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL- Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; Email: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

Date of preparation: October 2024
UK/IE MAT-74848