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.

Taking Adtralza®

 

What you should know before taking Adtralza®

Do not use Adtralza® if you are allergic to tralokinumab or any of the other ingredients of this medicine, which include: sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polysorbate 80 (E433) and water for injection.

If you think you may be allergic, or are not sure, ask your doctor, pharmacist or nurse for advice before using Adtralza®.

 

Attention

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Adtralza®:

Allergic reactions: Very rarely, medicines can cause allergic (hypersensitivity) reactions and severe allergic reactions called anaphylaxis. You must look out for signs of these reactions (such as breathing problems, swelling of the face, mouth and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Adtralza®.

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

Parasitic infection in the intestines: Adtralza® may reduce your resistance to infections caused by parasites. Any parasitic infection should be treated before you start treatment with Adtralza®. Tell your doctor if you have diarrhoea, gas, upset stomach, greasy stools and dehydration, which could be signs of a parasitic infection. If you live in a region where these infections are common or if you are travelling to such a region, tell your doctor.

Eye problems: Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Full information on possible side effects can be found in the patient information leaflet that was provided to you with your medication.

Medicine

Children

Do not give this medicine to children below the age of 12 years because the safety and benefits of Adtralza® are not yet known

 

Other medicines and Adtralza®

Tell your doctor or pharmacist:

- If you are using, have recently used or might use any other medicines.

- If you have recently had a vaccination or are due to have one.

 

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Adtralza® in pregnant women are not known; therefore it is preferable to avoid using it during pregnancy unless your doctor advises you to use it

If applicable, you and your doctor should decide if you will breastfeed or use Adtralza®. You should not do both.

 

Driving and using machines

Adtralza® is unlikely to reduce your ability to drive and use machines.

 

Adtralza® contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 150mg, that is to say essentially “sodium-free”.

Syringes

Adtralza® contents and storage

The active substance in Adtralza® is tralokinumab. Adtralza® is available in two injection formats:

  • A pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution for injection.
  • A pre-filled injection pen contains 300 mg of tralokinumab in 2 mL solution for injection.

Your care team will help you choose the format that best suits your needs.

The other ingredients are sodium acetate trihydrate (E262), acetic acid (E260), sodium chloride, polysorbate 80 (E433) and water for injections.

Adtralza® is a clear to opalescent, colourless to pale yellow solution, supplied in either a glass pre-filled syringe with a needle guard or pre-filled injection pen.

How to store Adtralza®

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the label and pack after EXP. The expiry date refers to the last day of that month.

Keep in the original package in order to protect from light.

Store in a refrigerator (2° C to 8° C). Do not freeze.

If necessary, Adtralza® pre-filled syringes may be kept at room temperature up to 25° C in the original package for a maximum of 14 days.
Do not store above 25° C. Throw away Adtralza® if it is not used within 14 days of storage at room temperature.

If necessary, Adtralza® pre-filled pens may be kept at room temperature up to 30° C in the original package for a maximum of 14 days.
Do not store above 30° C. Throw away Adtralza® if it is not used within 14 days of storage at room temperature.

If you need to permanently remove the pack from the refrigerator, write down the date of removal, and use Adtralza® within 14 days. Adtralza® must not be refrigerated again during the period.

Do not use this medicine if you notice that it is cloudy, discoloured or has particles in it.

Do not throw away any medicines via wastewater or household waste. You will be provided with a sharps bin for safe disposal of used syringes and other injection equipment. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

How much Adtralza® will you need to take and for how long?

  • Your doctor will decide how much Adtralza® you need and for how long.
  • Inject Adtralza® yourself only after you have been trained by your doctor or nurse. A caregiver may also give you your Adtralza® injection after proper training.

Using the pre-filled syringes

  • The recommended first dose of Adtralza® is 600 mg (four 150 mg injections).
  • The first dose is followed by 300 mg (two injections) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks.

Using the pre-filled pens

  • The recommended first dose of Adtralza® is 600 mg (two 300 mg injections).
  • The first dose is followed by 300 mg (one 300 mg injection) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks.

How to take Adtralza®

Adtralza® is given by injection under your skin (subcutaneous injection).

You and your doctor or nurse can decide if you can inject Adtralza® yourself.

Pre-filled Pen

Learn how to inject Adtralza® in this step-by-step video for the pre-filled pen.

Refer to the 'instructions for use' found in the Patient Information Leaflet (PIL) that comes in your Adtralza® pack for written instructions.

UK/IE MAT-70065
December 2023

Pre-filled Syringe

Learn how to inject Adtralza® in this step-by-step video for the pre-filled syringe.

Refer to the 'instructions for use' found in the Patient Information Leaflet (PIL) that comes in your Adtralza® pack for written instructions.

UK/IE MAT-62108
February 2023

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-74849