Ebglyss 250 mg solution for injection in pre-filled pen: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebglyss 250mg solution for injection in pre-filled pen

lebrikizumab

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What Ebglyss is and what it is used for
What you need to know before using Ebglyss
How to use Ebglyss
Possible adverse reactions
How to store Ebglyss
Contents of the pack and other information

Instructions for use

1. What Ebglyss is and what it is used for

Ebglyss contains the active substance lebrikizumab.

Ebglyss is used to treat adults and adolescents aged 12 years and older with a body weight of at least 40 kg who have moderate to severe atopic dermatitis, also known as atopic eczema, that may be treated with systemic therapies (a medicine taken by mouth or given by injection).

Ebglyss may be given alone or in combination with eczema treatments applied to the skin.

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 symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve your atopic dermatitis and reduce associated skin itching and discomfort.

2. What you need to know before using Ebglyss

Do not use Ebglyss

if you are allergic to lebrikizumab or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

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

Each time you receive a new pack of Ebglyss, it is important to record the date and the batch number (found on the packaging after "Batch") and keep this information in a safe place.

Allergic reactions

Very rarely, this medicine may cause allergic reactions (hypersensitivity). These reactions may occur shortly after starting 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 immediate medical attention. Signs of an allergic reaction include:

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

Eye problems

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

Vaccines

Speak with your doctor about your current vaccination schedule. See section “Other medicines and Ebglyss”.

Children and adolescents

This medicine should not be used in children with atopic dermatitis under 12 years of age, or in adolescents aged 12 to 17 years who weigh less than 40 kg, as it has not been evaluated in these age groups.

Other medicines and Ebglyss

Inform your doctor or pharmacist if:

you are taking, have recently taken, or might need to take any other medicines;
you have recently been vaccinated or plan to be vaccinated. You should not receive certain types of vaccines (live vaccines) during treatment with Ebglyss.

Pregnancy, breastfeeding, and fertility

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

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

It is unknown whether lebrikizumab passes into breast milk. 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 using machines

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

Ebglyss contains polysorbates

This medicine contains 0.6 mg of polysorbate 20 (E 432) per pre-filled pen, equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Ebglyss

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 how long you should use it.

The recommended dose is:

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

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

One injection of 250 mg every four weeks starting from week 16 onwards (maintenance regimen).

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

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

It is important that you do not attempt to self-inject until your doctor or nurse has shown you how to do so. It is also possible that a caregiver who has been properly trained may administer Ebglyss injections to you. For adolescents aged 12 years and older, it is recommended that Ebglyss be administered by an adult or under adult supervision.

The pre-filled pen must not be shaken.

Carefully read the "Instructions for Use" of the pre-filled pen before administering Ebglyss.

If you use more Ebglyss than you should

If you use more Ebglyss than prescribed by your doctor or administer the dose earlier than scheduled, speak with your doctor, pharmacist, or nurse.

If you forget to use Ebglyss

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

If you forget to inject Ebglyss at your usual scheduled time, administer the injection as soon as you remember. The next dose should then be injected as normally scheduled.

If you stop using Ebglyss

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebglyss

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Do not use this medicine if you notice that the solution is cloudy or has changed colour, or if it contains visible particles. After removal from the refrigerator, Ebglyss must be stored below 30 °C and used within 7 days; otherwise, it must be discarded. Once stored outside the refrigerator, it must not be returned to refrigerated storage. You may write down the date of removal from the refrigerator on the medicine carton.

This medicine is for single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Ebglyss

The active substance is lebrikizumab. Each pre-filled pen contains 250 mg of lebrikizumab in 2 ml of solution (125 mg/ml).
The other components are histidine, glacial acetic acid (E260), sucrose, polysorbate 20 (E432), and water for injections.

Appearance of the product and contents of the container

Ebglyss is a sterile injectable solution ranging from clear to opalescent, colourless to slightly yellowish or slightly brownish, and free from visible particles. It is supplied in cardboard packs containing one single-dose pre-filled pen, two single-dose pre-filled pens, or three single-dose pre-filled pens, and in multiple packs containing four single-dose pre-filled pens (2 packs of 2), five single-dose pre-filled pens (5 packs of 1), or six single-dose pre-filled pens (3 packs of 2). Only certain pack sizes may be marketed.

Marketing Authorization Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona

Spain

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Black text on white background with the names Belgie Belgique Belgien, Luxembourg Luxemburg, Almirall N.V. and the telephone number +32 (0)2 771 86 37

Iceland

Vistor ehf.

Tel: +354 535 70 00

List of European country names in various languages on white lines followed by the name Almirall S.A. and a telephone number with Spanish country code

Italy

Almirall SpA

Tel.: +39 02 346181

Czech Republic/Slovakia

Almirall s.r.o

Tel: +420 739 686 638

Netherlands

Almirall B.V.

Tel: +31 (0) 30 711 15 10

Denmark/Norway/Sweden

Almirall ApS

Tlf/Tel: +45 70 25 75 75

Austria

Almirall GmbH

Tel.: +43 (0)1/595 39 60

Germany

Almirall Hermal GmbH

Tel.: +49 (0)40 72704-0

Poland

Almirall Sp.z o. o.

Tel.: +48 22 330 02 57

France

Almirall SAS

Tel.: +33(0)1 46 46 19 20

Portugal

Almirall - Produtos Farmacêuticos, Lda.

Tel.: +351 21 415 57 50

Ireland

Almirall, S.A.

Tel: +353 1800 849322

Finland/Sweden

Orion Corporation

Puh/Tel: +358 10 4261

Date of the most recent review of this leaflet: 03/2025

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Instructions for use

These Instructions for Use contain information on how to administer Ebglyss injections.

Read these “Instructions for Use” before using this medicine and carefully follow all instructions step by step.

White cylindrical medical auto-injector with transparent tip, red and green color indicators, and a purple cap on the right side

Important information you need to know before injecting Ebglyss

Your doctor must explain to you how to prepare and inject Ebglyss using the pre-filled pen. Do not inject Ebglyss yourself or administer it to another person until you have been properly trained to do so.

Each Ebglyss pre-filled pen contains 1 dose of Ebglyss (250 mg). The pre-filled pen is for single use only.

The Ebglyss pre-filled pen contains glass components. Handle with care. If it is dropped onto a hard surface, do not use it. Use a new Ebglyss pre-filled pen for the injection.

Your doctor can help you decide where on the body the injection should be given. For further guidance on the best area for you, refer to the section titled Select and clean the injection site in these instructions.

If you have vision or hearing impairments, do not use the Ebglyss pre-filled pen without the help of a caregiver.

Parts of the Ebglyss pre-filled pen

Diagram of a medical device with labels indicating the purple button and other components

Preparation for Ebglyss injection
Gather supplies:
Ebglyss pre-filled pen from the refrigerator alcohol wipe	cotton ball or gauze sharps disposal container


Inspect the pre-filled pen and medication
Make sure you have the correct medication. The solution inside the pen should be clear. It may range from colorless to slightly yellow or slightly brown.
	Do not use the pre-filled pen (see section Disposal of the Ebglyss pre-filled pen) if: the pen appears damaged the medication has been frozen the solution is cloudy, has changed color, or contains particles the expiration date printed on the label has passed Do not heat the pre-filled pen using a microwave, hot water, or direct sunlight.

Wash your hands with soap and water

Select and clean the injection site
Your doctor can help you choose the most suitable injection site. Clean the injection site with an alcohol wipe and allow it to dry.
	You or someone else may administer the medication to you in the following areas.	Abdominal area: At least 5 cm away from the navel. Front of the thigh: At least 5 cm above the knee and 5 cm below the groin.
	Another person should administer the injection in this area.	Outer area of the upper arm: Another person should inject into the outer area of the upper arm. Do not inject into the exact same spot each time. Do not inject into areas of skin that are tender, bruised, red, hard, scarred, or affected by atopic dermatitis or other skin lesions.

Ebglyss Injection

1	Uncover the pre-filled pen
			Make sure the pre-filled pen is locked.
When you are ready to administer the injection, twist off the grey base cap and dispose of it in household waste. Do not replace the grey base cap, as it could damage the needle. Do not touch the needle inside the transparent base.

2	Attach and unlock
			Place the transparent base against the skin and hold it firmly in place.
	Keep the transparent base on the skin and then rotate the locking ring to the unlock position.

3	Press and hold for 15 seconds
		Press the purple injection button, keep it pressed, and wait until you hear two distinct clicks: first click = start of injection second click = end of injection The injection may last up to 15 seconds.
		You will know the injection is complete when the grey plunger becomes visible. Then, remove the pre-filled pen from the injection site.		Grey plunger

Disposal of the Ebglyss prefilled pen

Dispose of the used prefilled pen
	Dispose of the used Ebglyss prefilled pen into a sharps container immediately after use.
Do not throw (dispose of) the Ebglyss prefilled pen in household trash.
If you do not have a sharps container, you may use a household container that: is made of heavy-duty plastic; can be closed with a tight, puncture-resistant lid to prevent sharps from leaking out; stands upright and remains stable during use; is leak-proof; and is properly labeled to indicate it contains hazardous waste.
When the sharps container is almost full, follow your local guidelines for proper disposal. There may be national laws regarding the disposal of needles and syringes. For more information about safe disposal of sharps, ask your doctor about available options in your area. Do not recycle the used sharps container.
Frequently Asked Questions
Q.	What if there are bubbles in the prefilled pen?
R.	It is normal to have air bubbles. They will not harm you or affect your dose.

Q.	What if there is a drop of liquid at the needle tip when removing the grey base cap?
R.	It is normal to have a drop of liquid at the needle tip. It will not harm you or affect your dose.

Q.	What if I unlock the pen and press the purple injection button before turning the grey base cap?
R.	Do not remove the grey base cap. Dispose of (throw away) the prefilled pen and use a new one.

Q.	Should I keep pressing the purple injection button until the injection is complete?
R.	It is not necessary to keep pressing the purple injection button, but doing so may help you keep the prefilled pen steady and firmly against the skin.
Q.	What if the needle does not retract after the injection?
R.	Do not touch the needle or replace the grey base cap. Store the prefilled pen in a safe place to avoid accidental needlestick injury.


Q.	What if I have a drop of liquid or blood on the skin after the injection?
R.	This is normal. Apply pressure to the injection site with a cotton ball or gauze. Do not rub the injection site.

Q.	How can I tell if my injection is complete?
R.	After pressing the purple injection button, you will hear two loud clicks. The second loud click indicates that the injection is complete. You will also see the grey plunger at the top of the transparent base. The injection may take up to 15 seconds.

Q.	What if I remove the prefilled pen before the second loud click or before the grey plunger stops moving?
R.	You may not have received the full dose. Do not administer another injection. Contact your doctor for assistance.

Q.	What if I hear more than 2 clicks during the injection? (2 loud clicks and 1 soft click). Did I receive the full injection?
R.	Some people may hear a soft click just before the second loud click. This is normal pen function. Do not remove the prefilled pen from the skin until you hear the second loud click.

Read the entire package leaflet of the pre-filled syringe before using Ebgyss.