Prospect: information for the user

Ebglyss 250mg injectable solution in pre-filled syringe

lebrikizumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Ebglyss and what it is used for

2.What you need to know before starting to use Ebglyss

3.How to use Ebglyss

4.Possible adverse effects

5.Storage of Ebglyss

6.Contents of the package and additional information

Usage instructions

Ebglyss contains the active ingredient lebrikizumab.

Ebglyss is used to treat adults and adolescents 12 years of age and older with a body weight of at least 40 kg with moderate to severe atopic dermatitis, also known as atopic eczema, who may be treated with systemic treatments (medicines administered orally or by injection).

Ebglyss can be administered alone or in combination with topical eczema medicines.

Lebrikizumab is a monoclonal antibody (a type of protein) that blocks the action of another protein called interleukin 13. Interleukin 13 plays an important role in the appearance of atopic dermatitis symptoms. By blocking interleukin 13,Ebglyssmay improve your atopic dermatitis and reduce skin itching and pain associated with it.

No use Ebglyss

-if you are allergic to lebrikizumab or any of the other ingredients in this medicine (listed in section6).

If you think you might be allergic or are unsure, consult your doctor, pharmacist, or nurse before using Ebglyss.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ebglyss.

Each time you receive a new pack of Ebglyss, it is essential that you note the date and batch number (you will find this on the pack after “Batch”) and keep this information in a safe place.

Allergic reactions

In very rare cases, this medicine may cause allergic reactions (hypersensitivity). These reactions can occur shortly after starting to take Ebglyss, but may also occur later. If you notice symptoms of an allergic reaction, you must stop using the medicine and contact your doctor or seek medical attention immediately. The signs of an allergic reaction include:

• breathing problems
• swelling of the face, mouth, and tongue
• loss of consciousness
• dizziness
• lightheadedness (due to a drop in blood pressure)
• hives, itching, and skin rash.

Eye problems

Consult your doctor if you experience or worsening of any eye problems, such as redness and discomfort in the eye, eye pain, or changes in vision.

Vaccinations

Discuss your current vaccination program with your doctor. See the section “Other medicines and Ebglyss”.

Children and adolescents

This medicine should not be usedin children with atopic dermatitis under 12years of age or in adolescents from 12 to 17years of age and weighing less than 40kg,as it has not been evaluated in this age group.

Other medicines and Ebglyss

Inform your doctor or pharmacist if:

• you are using, have used recently, or may need to use any other medicine;
• you have recently been vaccinated or plan to be vaccinated. Do not receive certain types of vaccines (live vaccines) during treatment with Ebglyss.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The effects of this medicine on pregnant women are unknown; it is best to avoid using Ebglyss during pregnancy unless your doctor advises you to do so.

The passage of lebrikizumab into breast milk is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You and your doctor should decide whether to breastfeed or use Ebglyss. You should not do both.

Driving and operating machinery

It is unlikely that Ebglyss will affect your ability to drive and operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Ebglyss should be administered and for how long

Your doctor will decide how much Ebglyss you need and for how long you will use it.

The recommended dose is:

• Two initial injections of 250 mg of lebrikizumab each (500 mg in total) in week 0 and week 2.
• One injection with 250 mg every two weeks from week 4 to week 16.

Depending on how you respond to the medication, your doctor may decide to stop giving you the medication or continue giving you an injection of 250 mg every two weeks until week 24.

• One injection with 250 mg every four weeks from week 16 onwards (maintenance dose).

Ebglyss is administered by subcutaneous injection (under the skin) in the thigh or abdomen, except for the 5 cm around the navel. If someone else administers the injection, it can also be administered in the upper arm. You and your doctor or nurse will decide if you can inject Ebglyss yourself.

It is recommended to alternate the injection site with each injection. Ebglyss should not be injected in sensitive, damaged, or hematoma or scarred skin areas, or in skin areas affected by atopic dermatitis or other skin lesions. The initial dose of 500 mg should be administered in two consecutive injections of 250 mg in different injection sites.

It is essential that you do not attempt to administer the injection yourself until your doctor or nurse has taught you how to do it. It is also possible that a caregiver who has learned to do it well may administer the Ebglyss injections. In the case of adolescents, 12 years of age or older, it is recommended that Ebglyss be administered by an adult or administered under the supervision of an adult.

The pre-filled syringe should not be shaken.

Read the "Instructions for use" of the pre-filled syringe carefully before administering Ebglyss.

If you use more Ebglyss than you should

If you use more Ebglyss than your doctor prescribed or administer the dose earlier than planned, talk to your doctor, pharmacist, or nurse.

If you forgot to use Ebglyss

If you have forgotten to inject a dose of Ebglyss, consult your doctor, pharmacist, or nurse.

If you forgot to inject Ebglyss when you were supposed to, administer the injection when you remember it. The next dose should be injected normally on the day it is due.

If you interrupt treatment with Ebglyss

Do not stop using Ebglyss without first talking to your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent(may affect up to 1 in 10people)

• Redness and discomfort in the eye (conjunctivitis)
• Inflammation of the eye due to an allergic reaction (allergic conjunctivitis)
• Dry eye
• Reactions at the injection site

Less Frequent(may affect up to 1 in 100people)

• Herpes zoster (shingles), painful blistering eruption on a part of the body
• Increased eosinophils (a type of white blood cell, eosinophilia)
• Inflammation of the cornea (the transparent layer covering the front of the eye, keratitis)
• Itching, redness, and swelling of eyelids (blepharitis)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medication if you observe that the solution is cloudy, has changed color, or contains visible particles. Before use, remove the box from the refrigerator, remove the preloaded syringe from the box, and wait 45 minutes for it to reach room temperature. After removing it from the refrigerator, Ebglyss must be stored below 30°C and used within 7 days or discard. Once stored outside the refrigerator, it cannot be refrigerated again. You can note the date when you removed it from the refrigerator on the medication box.

This medication is for single use only.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ebglyss

• The active ingredient is lebrikizumab. Each pre-filled syringe contains 250mg of lebrikizumab in 2ml of solution (125mg/ml).
• The other components are histidine, glacial acetic acid (E260), sucrose, polisorbate20 (E432) and water for injection.

Appearance of the product and contents of the pack

Ebglyss is a sterile, transparent to opalescent, colourless to slightly yellowish or slightly brownish solution without visible particles. It is supplied in carton packs containing a pre-filled syringe of glass for single use or 2pre-filled syringes for single use, and in multiple packs containing 3pre-filled syringes (3 packs of 1), 4pre-filled syringes (2 packs of 2), 5pre-filled syringes (5 packs of 1) or 6pre-filled syringes (3 packs of 2).

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacture

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Spain

Almirall, S.A.

Phone: +34 93 291 30 00

Date of the last revision of this leaflet:11/2023.

The detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

Instructions for use

Read these ”Instructions for use” before administering this medicinal product and follow the instructions step by step.

Important information about the pre-filled syringe ofEbglysswith needle safety device:

Do not administer Ebglyss yourself or administer it to another person until your doctor has explained how to do it.In case of doubt, call your doctor.

During use of the pre-filled syringe of Ebglyss

•Consult your doctor about how often the injections of this medicinal product will be administered.

•If you have visual problems, do not use the pre-filled syringe of Ebglyss without the help of a caregiver.

•To reduce the risk of accidental needlestick injuries, each pre-filled syringe has a needle safety device that automatically covers the needle after administration of the injection.

•Dispose of (throw away) the used pre-filled syringe of Ebglyss immediately after use.

•Do notuse the pre-filled syringe of Ebglyss if it has fallen onto a hard surface or is damaged.

•Do notuse the pre-filled syringe of Ebglyss if the needle cap is missing or not securely attached.

•Do nottouch the plunger head until you are ready to administer the injection.

•Do notremove air bubbles from the pre-filled syringe of Ebglyss.

•Do notpull the plunger head at any time.

•Do notinject through clothing.

•Do notremove the needle cap until you are ready to administer the injection.

•Do not re-use a pre-filled syringe of Ebglyss.

Parts of the pre-filled syringe of Ebglysswith needle safety device

Before use

After use

Read the leaflet for the pre-filled syringe before using Ebglyss.