EBGLYSS 250 MG PRE-FILLED SYRINGE SOLUTION FOR INJECTION

Introduction

Package Leaflet: Information for the User

Ebglyss 250mg solution for injection in pre-filled syringe

lebrikizumab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ebglyss and what is it used for
2. What you need to know before you use Ebglyss
3. How to use Ebglyss
4. Possible side effects
5. Storage of Ebglyss
6. Contents of the pack and other information

Instructions for use

1. What is Ebglyss and what is it used for

Ebglyss contains the active substance lebrikizumab.

Ebglyss is used to treat adults and adolescents from 12 years of age with moderate to severe atopic dermatitis (also known as atopic eczema) who may be candidates for systemic therapy (medicine given by mouth or by injection).

Ebglyss can be given alone or in combination with medicines for eczema that are 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 occurrence of symptoms of atopic dermatitis. By blocking interleukin 13, Ebglyss can improve your atopic dermatitis and reduce the itching and skin pain associated with it.

2. What you need to know before you use 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, talk to your doctor, pharmacist, or nurse before using Ebglyss.

Warnings and precautions

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

Each time you get a new pack of Ebglyss, it is important that you note the batch number (found on the pack after “Batch”) and that you keep this information in a safe place.

Allergic reactions

Very rarely, this medicine may cause allergic reactions (hypersensitivity). These reactions may occur soon after starting Ebglyss, but may also occur later. If you notice that you have symptoms of an allergic reaction, you must stop using the medicine and contact your doctor or get medical attention immediately. The signs of an allergic reaction include:

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

Eye problems

Talk to your doctor if you notice any eye problems, such as redness and discomfort in the eye, eye pain, or changes in vision.

Vaccines

Talk to your doctor about your current vaccination program. See the section “Other medicines and Ebglyss”.

Children and adolescents

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

Other medicines and Ebglyss

Tell your doctor or pharmacist if:

• you are using, have recently used, or might use any other medicines;
• you have recently been vaccinated or are planning to be vaccinated. You must not receive certain types of vaccines (live vaccines) during treatment with Ebglyss.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The effects of this medicine in pregnant women are not known; it is best to avoid using Ebglyss during pregnancy unless your doctor advises you to use it.

It is not known whether lebrikizumab passes into breast milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. You and your doctor must decide whether to breast-feed or use Ebglyss. You should not do both.

Driving and using machines

Ebglyss is unlikely to affect your ability to drive or use machines.

3. How to use Ebglyss

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

How much Ebglyss to use 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) 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 up to week 24.

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

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

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

It is important that you do not try to give yourself the injection 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 give you 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 under the supervision of an adult.

The pre-filled syringe must 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 if you inject the dose earlier than planned, talk to your doctor, pharmacist, or nurse.

If you forget to use Ebglyss

If you forget to inject a dose of Ebglyss, talk to your doctor, pharmacist, or nurse.

If you forgot to inject Ebglyss when you usually do, inject the dose when you remember. The next dose should be injected as usual on the scheduled day.

If you stop using Ebglyss

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people)

• 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

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster (shingles), a painful rash with blisters on one 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 the eyelids (blepharitis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month shown.

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

Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not use this medicine if you notice that the solution is cloudy, has changed color, or contains visible particles. Before use, remove the carton from the refrigerator, remove the pre-filled syringe from the carton, and wait 45 minutes to reach room temperature. After removal from the refrigerator, Ebglyss should be stored below 30°C and used within 7 days or discarded. Once stored at room temperature, it must not be refrigerated again. You can write the date you removed it from the refrigerator on the carton.

This medicine is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Ebglyss Composition

• The active ingredient is lebrikizumab. Each prefilled syringe 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 injectable preparations.

Product Appearance and Container Contents

Ebglyss is a sterile injectable solution that is transparent to opalescent, colorless to slightly yellow or slightly brown, and free of visible particles. It is supplied in cartons containing a single-dose glass prefilled syringe or 2 single-dose prefilled syringes, and in multiple packs containing 3 single-dose prefilled syringes (3 packs of 1), 4 single-dose prefilled syringes (2 packs of 2), 5 single-dose prefilled syringes (5 packs of 1), or 6 single-dose prefilled syringes (3 packs of 2).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Spain

Almirall, S.A.

Tel: +34 93 291 30 00

Date of Last Revision of this Leaflet: 11/2023.

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

Instructions for Use

Read these "Instructions for Use" before administering this medicinal product and carefully follow all the step-by-step instructions.

Important Information about the Ebglyss Prefilled Syringe with Needle Safety System:

You should not inject Ebglyss yourself or have someone else inject it for you until your doctor has explained how to do it.If you are unsure, contact your doctor.

During Use of the Ebglyss Prefilled Syringe

• Consult your doctor about how often injections of this medicinal product will be administered.
• If you have visual problems, do not use the Ebglyss prefilled syringe without the help of a caregiver.
• To reduce the risk of accidental needle pricks, each prefilled syringe has a needle safety system that automatically activates to cover the needle after injection.
• Discard (throw away) the used Ebglyss single-dose prefilled syringe immediately after use.
• Do not use the Ebglyss prefilled syringe if it has been dropped onto a hard surface or is damaged.
• Do not use the Ebglyss prefilled syringe if the needle cap is missing or not firmly attached.
• Do not touch the plunger head until you are ready for injection.
• Do not remove air bubbles from the Ebglyss prefilled syringe.
• Do not pull the plunger head at any time.
• Do not inject through clothing.
• Do not remove the needle cap until just before you are ready to administer the injection.
• Do not reuse a single-dose Ebglyss prefilled syringe.

Parts of the Ebglyss Prefilled Syringe with Needle Safety System

Before Use

After Use

Read the complete leaflet of the prefilled syringe before using Ebglyss.