Ebglyss

Package leaflet: Information for the user

Ebglyss 250 mg solution for injection in pre-filled syringe

lebrikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Ebglyss is and what it is used for
2. What you need to know before using Ebglyss
3. How to use Ebglyss
4. Possible side effects
5. How to store Ebglyss
6. 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, and who are candidates for systemic therapy (i.e., a medicine taken orally or by injection).
Ebglyss may be used together with topical eczema medicines (applied to the skin) or alone.
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 causing the symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve 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 to 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 using Ebglyss.
Each time you receive a new pack of Ebglyss, it is important to record the date and the batch number (found on the pack 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 immediately after taking Ebglyss, but may also occur later. If you notice symptoms of an allergic reaction, you must stop using this medicine and contact your doctor or healthcare provider immediately. Signs of an allergic reaction include:

• breathing difficulties
• 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
Contact your doctor if you experience new or worsening eye problems, including eye redness and irritation, eye pain, or changes in vision.
Vaccination
Talk to your doctor about your current vaccination schedule. See the section “Other medicines and Ebglyss”.
Children and adolescents
This medicine must not be used in children under 12 years of age with atopic dermatitis, or in adolescents aged between 12 and 17 years weighing less than 40 kg, as it has not been studied in these age groups.
Other medicines and Ebglyss
Inform your doctor or pharmacist:

• if you are currently using, have recently used, or might use any other medicines.
• if you have recently received a vaccination or if you plan to be vaccinated. While using Ebglyss, you must not receive certain types of vaccines (live vaccines).

Pregnancy, breast-feeding, and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor before taking this medicine.
The effects of this medicine in pregnant women are unknown. It is best to avoid using Ebglyss during pregnancy unless your doctor recommends 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 will need to decide whether to breast-feed or use Ebglyss. You must 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 syringe, equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Ebglyss

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Ebglyss is administered and for how long
Your doctor will decide how much Ebglyss you need and for how long you should use it.
The recommended dose is:

• Two initial injections of lebrikizumab, 250 mg 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 your response to the medicine, your doctor may decide to discontinue treatment or continue with a 250 mg injection every other week until week 24.
• One injection of 250 mg every four weeks starting from week 16 (maintenance dose).

Ebglyss is administered by subcutaneous injection (injection under the skin) in the thigh or
abdomen, except within 5 cm around the navel. If the injection is given by
another person, it may also be administered in the upper arm. You and your doctor or
nurse will decide whether you can self-inject Ebglyss.
It is recommended to change the injection site with each injection. Ebglyss must not be injected into
skin that is painful, damaged, bruised, or scarred, or in an area of skin affected by atopic dermatitis or
other skin lesions. For the initial 500 mg dose, administer two 250 mg injections
consecutively at different injection sites.
It is important not to attempt self-injection until you have been properly trained by your
doctor or nurse. A caregiver may also administer the Ebglyss injection after adequate
training. In adolescents aged 12 years and older, it is recommended that Ebglyss be administered by an adult or under adult supervision.
The pre-filled syringe must not be shaken.
Carefully read the “Instructions for use” of the pre-filled syringe before using Ebglyss.
If you use more Ebglyss than you should
If you have taken a higher dose of Ebglyss than prescribed by your doctor or taken the dose earlier than scheduled, contact your doctor, pharmacist, or nurse.
If you forget to use Ebglyss
If you have forgotten to inject a dose of Ebglyss, contact your doctor, pharmacist, or nurse.
If you have forgotten to inject Ebglyss at the scheduled time, administer it as soon as you remember. The next dose should be injected on the regularly scheduled day.
If you stop using Ebglyss
Do not stop using Ebglyss without first discussing it with your doctor.
If you have any doubts about how to use this medicine, consult 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)

• Eye redness and discomfort (conjunctivitis)
• Eye inflammation due to an allergic reaction (allergic conjunctivitis)
• Dry eyes
• Reactions at the injection site

Uncommon (may affect up to 1 in 100 people)

• Shingles, a painful skin rash with blisters on one part of the body (herpes zoster)
• Increase in eosinophils (a type of white blood cells; eosinophilia)
• Inflammation of the cornea (the transparent layer covering the front of the eye; keratitis)
• Itching, redness and swelling of the eyelid (blepharitis)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
Store in a refrigerator (2°C – 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. Before use, remove the carton from the refrigerator, take the pre-filled syringe out of the carton and allow it to reach room temperature by waiting 45 minutes. After removal from the refrigerator, Ebglyss must be stored at a temperature below 30°C and used within 7 days or disposed of. Once removed from the refrigerator, do not return it to the refrigerator. The date of removal from the refrigerator may be recorded on the carton.
This medicine is for single use only.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ebglyss contains

• The active substance is lebrikizumab. Each pre-filled syringe contains 250 mg of lebrikizumab in a 2 mL solution (125 mg/mL).
• The other ingredients are histidine, glacial acetic acid (E 260), sucrose, polysorbate 20 (E 432) and water for injections.

Description of the appearance of Ebglyss and contents of the pack
Ebglyss is a sterile injectable solution ranging from clear to opalescent, from colourless to slightly yellow or slightly brown, and free from visible particles. It is supplied in packs containing one single-dose pre-filled glass syringe, two single-dose pre-filled syringes, or three single-dose pre-filled syringes, and in multiple packs containing 4 single-dose pre-filled syringes (2 packs of 2), 5 single-dose pre-filled syringes (5 packs of 1), or 6 single-dose pre-filled syringes (3 packs of 2).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Ísland
Luxembourg/Luxemburg Vistor hf.
Almirall N.V Sími: +354 535 70 00
Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ Ελλάδα/ España/ Italia
Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Almirall SpA
Magyarország/ Malta/ România/ Slovenija/ Tel.: +39 02 346181
Almirall, S.A.
Teл./ Tel/ Τηλ: +34 93 291 30 00

Česká republika/Slovenská republika Nederland
Almirall s.r.o Almirall B.V.
Tel: +420 739 686 638 Tel: +31 (0) 30 711 15 10

Danmark/ Norge/ Suomi/Finland/ Sverige Österreich
Almirall ApS Almirall GmbH
Tlf/ Puh/Tel: +45 70 25 75 75 Tel: +43 (0)1/595 39 60

Deutschland Polska
Almirall Hermal GmbH Almirall Sp.z o. o.
Tel.: +49 (0)40 72704-0 Tel.: +48 22 330 02 57

France Portugal
Almirall SAS Almirall Produtos Farmacêuticos, Lda.
Tél.: +33(0)1 46 46 19 20 Tel: +351 21 415 57 50

Ireland
Almirall, S.A.
Tel: +353 1800 849322

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .

Instructions for use

Read these “Instructions for use” carefully before taking this medicine and follow all instructions step by step.
Important information about the pre-filled syringe Ebglyss with safety device for the needle:
Do not administer the injection yourself or to someone else until your healthcare provider has shown you how to inject Ebglyss. If you have any questions, contact your doctor.
When to use the pre-filled syringe Ebglyss

• Talk to your healthcare provider about how often you should inject the medicine.
• If you have vision problems, do not use the pre-filled syringe Ebglyss without assistance from the person caring for the patient.
• To reduce the risk of accidental needle sticks, each pre-filled syringe is equipped with a safety device for the needle, which automatically activates to cover the needle after injection.
• Dispose of (discard) the single-dose pre-filled syringe Ebglyss immediately after use.
• Do not use the pre-filled syringe Ebglyss if it has fallen on a hard surface or if it is damaged.
• Do not use the pre-filled syringe Ebglyss if the needle cap is missing or not securely attached.
• Do not touch the plunger rod until you are ready to inject.
• Do not remove any air bubbles from the pre-filled syringe Ebglyss.
• Do not pull back the plunger rod.
• Do not inject through clothing.
• Do not remove the needle cap until you are ready to administer the injection.
• Do not reuse a single-dose pre-filled syringe Ebglyss.

Parts of the pre-filled syringe Ebglyss with safety device for the needle
Before use

After use

Preparing for Ebglyss injection
Prepare materials Make sure you have the following:

• 1 Pre-filled syringe Ebglyss with

safety device for the needle
taken from the refrigerator

• 1 alcohol wipe*
• 1 cotton ball or gauze*
• 1 sharps disposal container*

*Items not included with the product.
Remove the pre-filled syringe from the Remove the pre-filled syringe Ebglyss
package from the package by holding the
middle part of the syringe barrel.

Keep the needle cap on until you are ready
to inject.
Inspect the pre-filled syringe When you receive the pre-filled syringes
Ebglyss, always check that you have the
correct medicine and dose, and visually
inspect the pre-filled syringe .
Note: You may gently rotate the plunger
rod to view the syringe label.
The label should state “Ebglyss”.
Do not use the pre-filled syringe
Ebglyss if the expiration date has passed.
Do not use the pre-filled syringe
Ebglyss if it is damaged.
Observe the medicine through the viewing
window on the pre-filled syringe Ebglyss. The liquid should be transparent, from colorless to slightly yellow or slightly brown.
Note: Some air bubbles are normal.
Do not use the pre-filled syringe
Ebglyss if the liquid has changed color or is
cloudy, if it contains flakes or visible particles,
if the syringe shows signs of damage,
if the syringe has been dropped, or if the medicine is frozen.
Bring to room temperature Place the pre-filled syringe Ebglyss on
a flat surface and allow it to warm to room
temperature for at least 45 minutes.

Do not heat the pre-filled syringe
Ebglyss with a microwave or warm water.
Do not expose the pre-filled syringe Ebglyss
to direct sunlight.
Choose the injection site • You may inject into the thigh or
the stomach area (abdomen), except

for the 5 cm around the navel
You or another person can (belly).
administer the injection in these • If the front of the thigh is chosen,
areas. inject at least 5 cm above the knee
and 5 cm below the groin.

• If choosing the outer area of the upper arm, assistance from the person caring for the patient will be required.

• Choose a different injection site each time you inject Ebglyss. Another person must administer the injection in this area.
  Do not inject into areas where the skin is tender, bruised, red, hard, scarred, or in an area affected by atopic dermatitis or other skin lesions.

Prepare the skin Wash your hands with soap and water. Clean the injection site with an alcohol wipe. Allow the injection site to dry before administering the injection.
Do not touch the injection site again or blow on it before the injection.
Injecting Ebglyss
1
Remove the needle cap
Hold the pre-filled syringe Ebglyss at the

center of the syringe barrel with the
needle pointing away from yourself and
remove the needle cap.
Do not reattach the needle cap.
Do not touch the needle.
Inject the medicine immediately after removing the needle cap.
2
Pinch the injection site
Gently pinch a fold of skin at the

injection site (thigh or stomach, except
for the 5 cm around the navel, or in the
outer area of the upper arm if injected
by the person caring for the patient).
3
Insert the needle
Insert the needle completely into the

skin fold at an angle of approximately
45°.
4
Push the plunger rod
Gently release the pinch while keeping

the needle in place.
Slowly and steadily push the plunger
rod down until it stops and the pre-filled
syringe is empty.
Note: It is normal to feel some resistance.
5
Release and remove
Lift your thumb to release the plunger

rod to activate the safety device and
cover the needle, then remove the
pre-filled syringe from the injection site.
Gently press a cotton ball or gauze
over the injection site if bleeding occurs.
Do not reattach the needle cap.
Do not rub the skin after injection.
Dispose of the pre-filled syringe safely
Place the used pre-filled syringe Ebglyss and the needle cap into a sharps disposal container immediately after use.
Do not dispose of (throw away) pre-filled

syringes Ebglyss and needle caps in household waste.
If you do not have a sharps disposal container, you may use a household container that is:

• made of strong plastic,
• closable with a tight, puncture-resistant lid to prevent sharps from falling out,
• kept upright and stable during use,
• leak-proof, and
• properly labeled to indicate the presence of hazardous waste inside the container.

When the sharps disposal container is nearly full, follow local guidelines for proper disposal. There may be local laws regarding the disposal of used needles and syringes.
For further information about safe disposal of sharps, you may ask your doctor about available options in your area.
Do not recycle used sharps disposal containers.
Read the entire instruction leaflet of the pre-filled syringe before using

Ebglyss.

Package leaflet: information for the user

Ebglyss 250 mg solution for injection in pre-filled pen

lebrikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Ebglyss is and what it is used for
2. What you need to know before using Ebglyss
3. How to use Ebglyss
4. Possible side effects
5. How to store Ebglyss
6. 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, and who are candidates for systemic therapy (i.e., a medicine administered orally or by injection).
Ebglyss may be used with topical eczema medications (applied to the skin) or alone.
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 causing the symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve atopic dermatitis and reduce associated itching and skin pain.

2. What you need to know before using Ebglyss

Do not use Ebglyss

• if you are allergic to lebrikizumab or to 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 using Ebglyss.
Each time you receive a new pack of Ebglyss, it is important to record the date and the batch number (found on the pack after “Lotto”) and keep this information in a safe place.

Allergic reactions
Very rarely, this medicine may cause allergic reactions (hypersensitivity). These reactions may occur immediately after taking Ebglyss, but may also occur later. If you notice symptoms of an allergic reaction, you must stop using this medicine and contact your doctor or healthcare provider immediately. Signs of an allergic reaction include:

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

Eye problems
Contact your doctor if you develop new or worsening eye problems, including eye redness and irritation, eye pain, or changes in vision.

Vaccination
Talk to your doctor about your current vaccination schedule. Refer to the 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 between 12 and 17 years who weigh less than 40 kg, as it has not been studied in these age groups.

Other medicines and Ebglyss
Inform your doctor or pharmacist:

• if you are currently using, have recently used, or might use any other medicines.
• if you have recently received a vaccination or if you plan to be vaccinated. While using Ebglyss, you should not receive certain types of vaccines (live vaccines).

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
The effects of this medicine in pregnant women are unknown. It is best to avoid using Ebglyss during pregnancy unless your doctor recommends it.
It is not known whether lebrikizumab passes into breast milk. If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine. You and your doctor will need to 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 known allergies.

3. How to use Ebglyss

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Ebglyss is 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 lebrikizumab, 250 mg 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 your response to the medicine, your doctor may decide to stop treatment or continue with a 250 mg injection every other week until week 24.
• One injection of 250 mg every four weeks starting from week 16 (maintenance dose).

Ebglyss is administered by subcutaneous injection (injection under the skin) into the thigh or
abdomen, except for the 5 cm area around the navel. If the injection is given by
another person, it may also be administered into the upper arm. You and your doctor or
nurse will decide whether you can self-inject Ebglyss.
It is recommended to change the injection site with each injection. Ebglyss must not be injected into skin that is painful, damaged, bruised, or scarred, or in an area of skin affected by atopic dermatitis or
other skin lesions. For the initial 500 mg dose, administer two 250 mg injections
consecutively at different injection sites.
It is important not to attempt self-injection until you have been trained by your
doctor or nurse. A caregiver may also administer Ebglyss injections after adequate
training. In 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 using Ebglyss.
If you use more Ebglyss than you should
If you have taken a higher dose of Ebglyss than prescribed by your doctor or have taken the dose earlier than scheduled, contact your doctor, pharmacist, or nurse.
If you forget to use Ebglyss
If you have forgotten to inject a dose of Ebglyss, contact your doctor, pharmacist, or nurse.
If you have forgotten to inject Ebglyss at the scheduled time, administer it as soon as you remember. The next dose should be injected on the regularly scheduled day.
If you stop using Ebglyss
Do not stop using Ebglyss without first discussing it with your doctor.
If you have any doubts about how to use this medicine, consult 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 of the eyes (conjunctivitis)
• Inflammation of the eye caused by an allergic reaction (allergic conjunctivitis)
• Dry eyes
• Reactions at the injection site

Uncommon (may affect up to 1 in 100 people)

• Shingles, a painful rash with blisters on one part of the body (herpes zoster)
• Increase in eosinophils (a type of white blood cells; eosinophilia)
• Inflammation of the cornea (the transparent layer covering the front part of the eye; keratitis)
• Itching, redness and swelling of the eyelid (blepharitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
Store in a refrigerator (2 °C - 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. Before use, remove the carton from the refrigerator, take the pre-filled pen out of the carton, and allow it to reach room temperature by waiting 45 minutes. After removal from the refrigerator, Ebglyss must be stored at a temperature below 30 °C and used within 7 days or discarded. Once stored outside the refrigerator, do not put it back into the refrigerator. The date of removal from the refrigerator may be recorded on the carton.
This medicine is for single use only.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Ebglyss contains

• The active substance is lebrikizumab. Each pre-filled pen contains 250 mg of lebrikizumab in a 2 mL solution (125 mg/mL).
• The other components are histidine, glacial acetic acid (E 260), sucrose, polysorbate 20 (E 432), and water for injections.

Description of the appearance of Ebglyss and pack contents
Ebglyss is a sterile injectable solution ranging from clear to opalescent, colourless to slightly yellow or slightly brown, and free from visible particles. It is supplied in 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 4 pre-filled single-dose pens (2 packs of 2), 5 pre-filled single-dose pens (5 packs of 1), or 6 pre-filled single-dose pens (3 packs of 2). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Almirall N.V
Tél/Tel: +32 (0)2 771 86 37

Ísland
Vistor hf.
Sími: +354 535 70 00

Luxembourg/Luxemburg
Almirall N.V
Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ Ελλάδα/ España/ Hrvatska/
Κύπρος/ Latvija/ Lietuva/ Magyarország/
Malta/ România/ Slovenija/
Almirall, S.A.
Teл./ Tel/ Τηλ: +34 93 291 30 00

Italia
Almirall SpA
Tel.: +39 02 346181

Česká republika/Slovenská republika
Almirall s.r.o
Tel: +420 739 686 638

Nederland
Almirall B.V.
Tel: +31 (0) 30 711 15 10

Danmark/ Norge/ Suomi/Finland/ Sverige
Almirall ApS
Tlf/ Puh/Tel: +45 70 25 75 75

Österreich
Almirall GmbH
Tel: +43(0) 1/595 39 60

Deutschland
Almirall Hermal GmbH
Tel.: +49 (0)40 72704-0

Polska
Almirall Sp.z o.o.
Tel.: +48 22 330 02 57

France
Almirall SAS
Tél.: +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

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/ .

Instructions for use

These Instructions for use contain information on how to inject Ebglyss.
Read these “Instructions for use” carefully before taking this medicine and
follow all instructions step-by-step.

Important information to know before injecting Ebglyss

• A healthcare provider must show you how to prepare and inject Ebglyss using the pre-filled pen. Do not administer the injection yourself or to someone else until you have been shown how to inject Ebglyss.
• 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 parts. Handle with care. If dropped onto a hard surface, do not use it. Use a new Ebglyss pre-filled pen for the injection.
• Your healthcare provider can help you decide where to inject your dose on your body. You may also read the section Choosing and cleaning the injection site of these instructions to help select the most suitable area.
• If you have vision or hearing problems, do not use the Ebglyss pre-filled pen without the help of a caregiver.

Parts of the Ebglyss pre-filled pen

Preparing to inject Ebglyss
Gather the supplies:

• Ebglyss pre-filled pen removed from the refrigerator • cotton ball or gauze pad
  • sharps disposal container
  • alcohol wipe

Wait 45 minutes
Remove the Ebglyss pre-filled pen from its packaging with the grey base cap attached and allow the
pre-filled pen to warm to room temperature for 45 minutes before injection.

• Do not warm the pre-filled pen using a microwave, hot water, or direct sunlight.
• Do not use the pre-filled pen if the medicine has been frozen.

Inspect the pre-filled pen and medicine
Make sure you have the correct medicine. The liquid inside should be clear. It may range from colourless to slightly yellow or slightly brown.
Do not use the pre-filled pen (see
Expiry date Disposal of the Ebglyss pre-filled pen ) if:

• the pen appears damaged

• the medicine is cloudy, has changed colour, or contains particles
• the expiry date printed on the label has passed

Wash hands with soap and water
Choose and clean the injection site
Your healthcare provider can help you choose the most suitable injection site.
Clean the injection site with an alcohol wipe and allow it to dry.

• Abdomen (stomach area) – Leave at least 5 cm away from the navel
  You or another person can administer the injection in these areas.

• Front of the thigh — At least 5 cm above the knee and 5 cm below the groin.

• Back of the upper arm — Another person must administer the injection in this area.

Do not inject into the same spot each time.
Another person must administer the injection in this area.
Do not inject into areas where the skin is tender, bruised, red, hard, scarred, or in an area affected by atopic dermatitis or other skin lesions.

Injecting Ebglyss
1
Remove the cap from the pre-filled pen

Ensure the pre-filled pen is locked.
When ready to inject, remove the grey base cap and dispose of it in household waste.
Do not reattach the grey base cap to avoid damaging the needle.
Do not touch the needle inside the transparent base.

2 Positioning and unlocking
Place and hold the transparent base firmly and evenly against the skin.
Place the transparent base on the skin, then rotate the locking ring to the unlock position.

3
Press and hold for 15 seconds

Press and hold the purple injection button and listen for two loud clicks:

• first click = injection started
• second click = injection completed

The injection may take up to 15 seconds.
You will know the injection is complete when the grey plunger becomes visible.

Grey plunger
Then, remove the pre-filled pen from the injection site.

Disposal of the Ebglyss pre-filled pen
Dispose of the used pre-filled pen

Immediately after use, place the used Ebglyss pre-filled pen into a sharps disposal container.
Do not throw away (dispose of) the Ebglyss pre-filled pen in household waste.
If you do not have a sharps disposal container, you may use a household container that is:

• made of heavy-duty plastic,
• closable with a tight-fitting, puncture-resistant lid that prevents sharps from coming out,
• kept upright and stable during use,
• leak-proof, and
• properly labelled to warn of hazardous waste inside the container.

When the sharps disposal container is nearly full, follow local guidelines for proper disposal of the container.
Local regulations may apply regarding the disposal of needles and syringes.
For more information on safe disposal of sharps, ask your doctor about available options in your area.
Do not recycle used sharps disposal containers.

Frequently asked questions
Q. What if I see bubbles in the pre-filled pen?
A. The presence of air bubbles is normal. They are not dangerous and will not affect your dose.
Q. What if there is a drop of liquid at the tip of the needle when I remove the grey base cap?
A. A drop of liquid at the needle tip is normal. It is not dangerous and will not affect your dose.
Q. What if I unlock the pen and press the purple injection button before removing the grey base cap?
A. Do not remove the grey base cap. Dispose of the pre-filled pen and use a new one.
Q. Do I need to hold the purple injection button pressed until the injection is complete?
A. It is not necessary to hold the purple injection button pressed, but it may help keep the pre-filled pen steady and firmly against the skin.
Q. What if the needle does not retract after the injection?
A. Do not touch the needle or reattach the grey base cap. Keep the pre-filled pen in a safe place to avoid accidental needle sticks.
Q. What if after the injection a drop of liquid or blood comes into contact with my skin?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. How can I tell if the injection is complete?
A. After pressing the purple injection button, you will hear 2 loud clicks. The second 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 pre-filled pen before the second click or before the grey plunger stops moving?
A. You may not have received the full dose. Do not administer another injection. Contact your healthcare provider 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?
A. Some people may hear a soft click just before the second loud click. This is normal pen function. Do not remove the pre-filled pen from the skin until you hear the second loud click.

Read the entire instruction leaflet of the pre-filled pen before using Ebglyss.