InfoCons Consumer Protection informs you – EXDENSUR – Package Leaflet

Before anything else

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 docto r, 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.

ℹ️ 1. What EXDENSUR is and what it is used for

EXDENSUR contains the active substance depemokimab , a monoclonal antibody (a type of protein designed to recognise and attach to a specific target in the body ).

EXDENSUR is used with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents aged 12 years and older . It is used in patients whose asthma is not properly controlled by high-dose inhaled corticosteroids plus another medicine to control asthma , and who have a type of airway inflammation called type 2 inflammation .

EXDENSUR is also used with other medicines to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults . CRSwNP is a long -term inflammation of the nose and sinuses, where soft, painless growths called polyps block the airways and make breathing difficult.

Patients with some types of asthma and CRSwNP have high levels of a protein called interleukin -5 (IL-5), which plays a role in the immune system (the body’s natural defences). IL-5 helps make and activate eosinophils, a type of white blood cell that can cause inflammation. The active substance in EXDENSUR , depemokimab, blocks IL-5. This reduces the number of eosinophils in the body, which helps to ease inflammation and improve symptoms of the disease .

⚠️ 2. What you need to know before you use EXDENSUR

Do not use EXDENSUR

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

➔ Check with your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor before using this medicine.

Worsening of asthma EXDENSUR is not a rescue medicine and must not be used to treat sudden breathing problems that may occur with asthma.

Some people get asthma -related side effects, or their asthma may become worse, during treatment with EXDENSUR . ➔ Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start EXDENSUR treatment .

Allergic reactions Medicines of this type (monoclonal antibodies) can cause severe allergic reactions such as anaphylaxis and angioedema ( rash, swelling of the face , throat or mouth , fast heartbeat, sweating, difficulty in breathing, collapse or loss of consciousness ) (see section 4, ‘Possible side effects’). These reactions may occur within hours after EXDENSUR is given, but in some cases they may occur days later. ➔ Seek medical attention immediately if you think you may be having a reaction.

If you may have had a similar reaction to any injection or medicine: ➔ tell your doctor before you are given EXDENSUR .

Parasitic infections EXDENSUR may weaken your resistance to infections caused by parasites. If you have a parasitic infection; it should be treated before you start treatment with EXDENSUR . If you live in a region where these infections are common or if you are travelling to such a region: ➔ check with your doctor if you think any of these may apply to you .

Children and adolescents

This medicine is not intended for use in children below 12 years of age for the treatment of asthma, or in children or adolescents below 18 years of age for the treatment of CRSwNP.

Other medicines and EXDENSUR

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Other medicines for asthma or CRSwNP  Don’t suddenly stop taking your medicines for your asthma or CRSwNP once you have started EXDENSUR . These medicines (especially ones called corticosteroids) must be stopped gradually, under the direct supervision of your doctor.

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

It is not known whether the ingredients of EXDENSUR can pass into breast milk. If you are breast -feeding, you must check with your doctor before you use EXDENSUR .

Driving and using machines

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

EXDENSUR contains polysorbate s

This medicine contains 0.2 mg of polysorbate 80 per 100 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

EXDENSUR contains sodium

This medicine contains less than 1 mmol sodium ( 23 mg) per 100 mg dose, that is to say essentially “sodium -free”.

💊 3. How to use EXDENSUR

EXDENSUR is given by injection under the skin ( subcutaneous ).

The recommended dose

• Asthma — for adults and adolescents aged 12 years and older , the recommended dose is 100 mg. You will have 1 injection every 6 months .
• CRSwNP — for adults , the recommended dose is 100 mg. You will have 1 injection every 6 months .

How to use Instructions for using the pre -filled syringe are given on the reverse of this leaflet .

Your doctor or nurse will decide if you or your caregiver can inject EXDENSUR . If appropriate, they will then give you or your caregiver training to show you the correct way to use EXDENSUR .

You can inject EXDENSUR under your skin in your stomach area (abdomen) or upper leg (thigh).

Your caregiver can also inject EXDENSUR into your upper arm. Do not inject into areas where the skin is tender, bruised, red, or hard. ➔ Contact your doctor or nurse if you find it difficult to inject yourself, or if you have any concerns about whether you have injected correctly or given yourself a complete dose .

If you forget to use EXDENSUR

If your doctor or healthcare professional usually gives you your injection of EXDENSUR : ➔ contact your doctor or hospital as soon as possible to re -schedule your appointment.

If you or your caregiver usually give the injection of EXDENSUR , and you miss a dose : ➔ inject a dose of EXDENSUR as soon as possible. After that, continue EXDENSUR on your usual planned injection day.

If you miss a dose by 1 month or more : ➔ inject a dose of EXDENSUR then restart your 6-month injection schedule from the day you inject the missed dose .

If you are not sure what to do, ask your doctor, pharmacist or nurse.

Don’t stop EXDENSUR without advice Do not stop injections of EXDENSUR unless your doctor advises you to. Interrupting or stopping the treatment with EXDENSUR may cause your symptoms to come back.

If your symptoms get worse while receiving injections of EXDENSUR : ➔ call your doctor.

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 )

• itching (pruritus)
• headache, tiredness, or rash around the time of injection
• reactions at the site of injection such as pain, redness, swelling, or itching Side effects that have been seen with similar medicines :
• severe allergic reactions such as anaphylaxis and angioedema (rash , swelling of the face , throat or mouth, fast heartbeat, sweating, difficulty in breathing, collapse or loss of consciousness ).

➔ Seek medical attention immediately if you think you may be having a reaction. ➔ Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

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 national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store EXDENSUR

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 and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8°C).

Do not freeze.

Do not shake.

Store in the original carton in order to protect from light.

The pre -filled syringe can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30 °C), when protected from light. After 7 days out of the refrigerator , dispose of the syringe according to local health and safety laws .

The pre -filled sy ringe must be used within 8 hours once the carton is opened. Discard if not used within 8 hours.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What EXDENSUR contains

• The active substance is depemokimab . Each mL of solution contains 100 mg of depemokimab.
• The other ingredients are histidine, histidine monohydrochloride, trehalose dihydrate, arginine hydrochloride, disodium edetate, polysorbate 80 (E 433), water for injections.

46 What EXDENSUR looks like and contents of the pack EXDENSUR is supplied as a 1 mL colourless, yellow to brown, clear to opalescent solution in a single -use pre -filled syringe .

EXDENSUR is available in pack s containing 1 pre -filled syringe .

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24 D24 YK11 Ireland

Manufacturer

GlaxoSmithKline Manufacturing S .p.A., Strada Provinciale Asolana N. 90, 43056 Torrile, Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00 Lietuva GlaxoSmithKline Trading Services Limited Tel: + 370 80000334 България GlaxoSmithKline Trading Services Limited Teл.: + 359 80018205 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00 Česká republika GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111 [email protected] Magyarország GlaxoSmithKline Trading Services Limited Tel.: + 36 80088309 Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Trading Services Limited Tel: + 356 80065004 Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 [email protected] Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 Eesti GlaxoSmithKline Trading Services Limited Tel: + 372 8002640 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 47 Ελλάδα GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Τηλ: + 30 210 68 82 100 Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 [email protected] España GlaxoSmithKline, S.A.

Tel: + 34 900 202 700 [email protected] Polska GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000 France Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 [email protected] Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00 [email protected] Hrvatska GlaxoSmithKline Trading Services Limited Tel: + 385 800787089 România GlaxoSmithKline Trading Services Limited Tel: + 40 800672524 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 Slovenija GlaxoSmithKline Trading Services Limited Tel: + 386 80688869 Ísland Vistor ehf.

Sími: +354 535 7000 Slovenská republika GlaxoSmithKline Trading Services Limited Tel: + 421 800500589 Italia GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Κύπρος GlaxoSmithKline Trading Services Limited Τηλ: + 357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija GlaxoSmithKline Trading Services Limited Tel: + 371 80205045 This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu 7. Step by step instructions for us e EXDENSUR 100 mg solution for injection in pre -filled syringe depemokimab for subcutaneous use This Instructions for Use contains information on how to inject EXDENSUR .

Read these sections first Before using your EXDENSUR pre-filled syringe, it is important that your healthcare provider explain s your EXDENSUR dosing instructions, and show s you (or your caregiver) how to use the syringe correctly .

Important information Read all of these instructions before using your syringe. If you do not follow these instructions, you may not get all your medicine.

Do not use EXDENSUR syringe

• if it has been frozen
• if it has been dropped or damaged
• if the security seal on the carton has been broken
• if the expiry date (EXP) has passed Do not:
• shake your EXDENSUR syringe
• share your syringe
• reuse your syringe
• expose your syringe to heat If any of these happen, dispose of the EXDENSUR syringe according to local health and safety laws and use a new EXDENSUR syringe.

Keep out of the sight and reach of children. Contains small parts.

49 Before use Grey needle cap (needle inside) Inspection window (medicine inside) Stopper White finger grip White plunger After use Grey needle cap Needle guard After use, the automatic needle guard is activated and pulls up (retracts) the needle Stopper Get to know your EXDENSUR pre-filled syringe 50 Storage Store the syringe in its carton Store EXDENSUR in a refrigerator (2°C – 8°C) in the original carton until you are ready to use it.

Do not freeze.

An unopened carton of EXDENSUR may be kept at room temperature up to 30°C for a maximum of 7 days. After being brought to room temperature, EXDENSUR must be used within 7 days.

After 7 days, dispose of the syringe according to local health and safety laws .

Once the syringe is removed from its carton After the EXDENSUR syringe is out of the carton, it must be used within 8 hours or dispose of the syringe according to local health and safety laws . Do not place it back in the refrigerator.

A. Prepare Gather supplies Supplied

• EXDENSUR syringe Not supplied
• Alcohol swab
• Cotton ball or gauze
• Adhesive plaster
• Sharps disposal container ( see Section C for disposal instructions ).

Take the carton containing your syringe out of the refrigerator

• Holding the middle of the syringe (near the inspection window), carefully take the syringe out of the tray.
• Do not remove the grey needle cap at this step.

Check your pre-filled syringe

• Check the expiry date. Do not use if the expiry date has passed.
• Look at the medicine in the pre-filled syringe through the inspection window. The medicine should be clear and colourless to yellow to brown .
• Do not inject if the medicine is cloudy, discoloured, or has particles.
• It is normal to see air bubbles. You do not need to do anything about it.
• Do not shake the syringe.

A1 Sharps disposal container A2 Take the syringe out of the tray A3 EXP: Month -Year Check the expiry date and the medicine 51 Wait 30 minutes

• Do not remove the grey needle cap.
• Place the syringe on a clean, flat surface away from direct sunlight and out of the sight and reach of children.
• Wait 30 minutes to bring to room temperature before you inject. Cold medicine is more painful to inject.
• Do not warm the syringe in a microwave, hot water, or direct sunlight.
• Do not use the syringe if it has been left out of the carton for more than 8 hours.

Choose your injection site

• If you are giving yourself the injection , you can inject into your thighs or stomach (abdomen).
• A caregiver or healthcare provider can inject into the upper arm, thigh, or abdomen.
• Do not inject yourself in the upper arm, as it is more difficult to avoid syringe movement during the injection.
• Do not inject where the skin is bruised, tender, red, or hard.
• Do not inject within 5 cm of your navel ( belly button ).

Clean the injection site

• Wash your hands with soap and water.
• Clean the injection site with an alcohol swab.

Allow skin to air dry.

• Do not fan or blow on the cleaned injection site.
• Do not touch the cleaned injection site again until you have finished your injection.

B. Inject Pull off the grey needle cap

• Remove the grey needle cap from the syringe by pulling it straight off, away from the needle (as shown). It may take some force to remove the grey needle cap.
• Do not handle the syringe by the white plunger while removing the grey needle cap .
• Do not let the needle touch any surface.
• Do not touch the needle.
• Do not try to remove any air bubbles from the syringe.
• Do not put the grey needle cap back onto the syringe. This could cause a needle injury.

A4 Wait 30 minutes A5 Patient or caregiver or healthcare provider Only caregiver or healthcare provider A6 B1 52 • Inject within 5 minutes after you remove the grey needle cap.

Position the syringe at the injection site

• Use your free hand to gently pinch the skin around the cleaned injection site.
• Keep pinching the skin throughout the injection.
• Do not handle the syringe by the white plunger while inserting the needle into the pinched skin.
• Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45 degree angle, as shown.

Start the injection

• Move your thumb to the white plunger and use your other fingers to hold onto the white finger grip, as shown.
• Slowly push down on the white plunger to inject the full dose.

Fully press the white plunger

• Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medicine is injected.

Slowly lift your thumb after the injection is complete

• Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically pull up (retract) into the needle guard.
• After removing the syringe from the injection site, release the pinched skin.
• Do not rub the injection site.

B2 B3 B4 Make sure white plunger is fully down B5 53 • Do not put the grey needle cap back onto the syringe .

• There may be a small drop of blood at the injection site. This is normal. Press a cotton ball or gauze on the area and apply an adhesive plaster if you need it.

C. Throw away

• Dispose of the used syringe and grey needle cap , according to local health and safety laws . Ask your doctor or pharmacist for advice if necessary.
• Keep your used syringes and needle caps out of the sight and reach of children.

Sharps disposal container

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information EXDENSUR (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/2007).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.