Ficha técnica de Ebglyss 250 mg solucion inyectable en pluma precargada – Espanha

Como usar Ebglyss 250 mg solucion inyectable en pluma precargada

Introduction

Prospecto: 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 prospectus carefully before starting to use this medicine, as it contains important information for you.

Keep this prospectus, 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 should 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 are not listed in this prospectus. See section 4.

1.What is Ebglyss and how it is used

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

Instructions for use

1. What is Ebglyss and how is it used

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 (a medication administered by mouth or by injection).

Ebglyss can be administered alone or in combination with eczema medications 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 symptoms of atopic dermatitis. By blocking interleukin 13, Ebglyss may improve your atopic dermatitis and reduce skin itching and pain associated with it.

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

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 to note the date and batch number (you will find this on the pack after “Batch”) and to 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)
itching, hives, and skin rash.

Eye problems

Consult your doctor if you experience or notice an increase in 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.

3. How to use Ebglyss

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 week16.

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 250mg every two weeks until week 24.

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

Ebglyss is administered by subcutaneous injection (under the skin) in the thigh or abdomen, except for the 5cm 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, or in skin affected by atopic dermatitis or other skin lesions. The initial dose of 500mg should be administered in two consecutive injections of 250mg 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 will administer the Ebglyss injections. In the case of adolescents, 12years 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 pen should not be agitated.

Read the “Instructions for use” of the pre-filled pen 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 Ebglyss, consult your doctor, pharmacist, or nurse.

If you forgot to inject Ebglyss when you are 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.

4. Possible Adverse Effects

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.

5. Conservation of Ebglyss

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 or has changed color or if it contains visible particles. Before use, remove the box from the refrigerator, remove the preloaded pen 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 thrown away 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.

6. Contents of the packaging and additional information

Composition of Ebglyss

The active ingredient is lebrikizumab. Each pre-filled pen 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 injectable solution that is transparent to opalescent, between colourless to slightly yellow or/and slightly brown and without visible particles. It is supplied in carton packs containing a single-dose pre-filled pen or 2single-dose pre-filled pens, and in multiple packs containing 3single-dose pre-filled pens (3packs of 1), 4single-dose pre-filled pens (2packs of 2), 5single-dose pre-filled pens (5 packs of 1) or 6single-dose pre-filled pens (3packs of 2). Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

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

Spain

Almirall, S.A.

Tel: +34 93 291 30 00

Last update of the leaflet: 11/2023.

Further information 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 medicinal product and follow all the instructions step by step.

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 inject it into another person until you have been explained how to do it.

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

Each pre-filled pen of Ebglyss contains glass parts. Handle it carefully. If it falls on a hard surface,do notuse it. Use a new pre-filled pen of Ebglyss for the injection.

Your doctor may help you decide where on the body to administer the injection. To know which area is best for you, you can also read the section titledChoose and clean the injection sitein these instructions.

If you have vision or hearing problems,do notuse the pre-filled pen of Ebglyss without the help of a caregiver.

Parts of the Ebglyss pre-filled pen

Preparation for Ebglyss injection
Prepare the supplies:
•pre-filled pen of Ebglyss from the refrigerator •alcohol wipe	•ball of cotton or gauze •container for disposing of sharp objects
Wait 45 minutes
Take the pre-filled pen of Ebglyss out of the carton with the grey cap at the base and let it come to room temperature for 45minutes before the injection. •Do notheat the pre-filled pen in the microwave, or with hot water or direct sunlight. •Do notuse the pre-filled pen if the medicinal product is frozen.

Inspect the pre-filled pen and the medicinal product
Make sure you have the correct medicinal product. The medicinal product inside the pre-filled pen must be transparent. It may be colourless to slightly yellow or/and slightly brown.
	Do notuse the pre-filled pen (see the sectionDisposal of the Ebglyss pre-filled pen) if: •the pre-filled pen appears to be damaged •the medicinal product is cloudy, has changed colour or contains particles •the expiry date printed on the label has passed

Wash your hands with water and soap

Choose and clean the injection site
Your doctor may help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let it dry.
	You or another person, can inject, or have the medicinal product injected, in these areas.	•Abdomen (stomach): At least 5cm from the navel. •Front of the thigh: At least 5 cm above the knee and 5 cm below the groin.
	Another person must inject the medicinal product in this area.	•Outer side of the arm: Another person must inject on the outer side of the arm. Do notinject in the same exact spot every time. Do notinject in areas of sensitive skin, with bruises, redness, hardness or scars, or in areas of skin affected by atopic dermatitis or other skin lesions.

Injection of Ebglyss

1	Remove the cap
			Make sure the pre-filled pen isblocked.
When ready to administer the injection, turn the grey cap at the base and throw it away. Do notput the grey cap back on, as it may damage the needle. Do nottouch the needle inside the transparent base.

2	Place and unblock
			Placethe transparent base against the skin and hold it firmly.
	Hold the transparent base against the skin and, then, turn the blocking ring to theunblockposition.

3	Pulse and hold for 15 seconds
		Pulsethe purple injection button,hold it pulsingand wait toheartwo strong clicks: •first click= start of the injection •second click= end of the injection The injection may take up to 15seconds.
		You will know the injection has finished when the grey plunger is visible. Then, remove the pre-filled pen from the injection site.		Grey plunger

Disposal of the Ebglyss pre-filled pen

Dispose of the used pre-filled pen
	Dispose of the used Ebglyss pre-filled pen in a sharps container immediately after use.
Do not throw (dispose) the used Ebglyss pre-filled pen in household waste.
If you do not have a sharps container, you can use a household container that: •is made of puncture-resistant plastic; •can be closed with a tight-fitting lid and is resistant to punctures, to prevent the sharp objects from escaping; •is upright and stable during use; •is puncture-proof and •is properly labelled to warn that it contains hazardous waste.
When the sharps container is almost full, you will need to follow the local guidelines for its proper disposal. There may be national laws on the disposal of needles and syringes. For more information on safe disposal of sharp objects, ask your doctor about the options available in your area. Do notrecycle the used container for sharp objects.
Frequently Asked Questions
Q.	What happens if there are bubbles in the pre-filled pen?
A.	It is normal to have air bubbles. They will not harm you or affect your dose.

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

Q.	What happens if I unblock the pre-filled pen and pulse the purple injection button before turning the grey cap at the base?
A.	Do notremove the grey cap at the base. Dispose of the pre-filled pen and use a new one.

Q.	Do I need to keep pulsing the purple injection button until the injection is complete?
A.	No, you do not need to keep pulsing the purple injection button, but it may help you keep the pre-filled pen stable and firmly against the skin.
Q.	What happens if the needle does not retract after the injection?
A.	Do nottouch the needle or put the grey cap back on. Store the pre-filled pen in a safe place to avoid accidental needlestick injury.


Q.	What happens if there is a drop of liquid or blood on the skin after the injection?
A.	This is normal. Press on the injection site with a ball of cotton or gauze.Do notrub the injection site.

Q.	How can I know if my injection has finished?
A.	After pulsing the purple injection button, you will hear 2 strong clicks. The second click indicates that the injection has finished. You will also see the grey plunger at the top of the transparent base. The injection may take up to 15seconds.

Q.	What happens if I remove the pre-filled pen before the second click or before the grey plunger has stopped moving?
A.	You may not have received the full dose. Do not administer another injection. Contact your doctor for help.

Q.	What happens if I hear more than 2clicks during the injection? (2 strong clicks and 1 soft click). Have I received the full dose?
A.	Some people may hear a soft click just before the second strong click. This is the normal functioning of the pre-filled pen.Do notremove the pre-filled pen from the skin until you hear the second strong click.