What it is and what it is used for

for

Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. It is used to treat severe asthma in adults, adolescents and children aged 6 years and older. Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs. This condition is called eosinophilic asthma – the type of asthma Nucala can treat. Nucala can reduce the number of asthma attacks, if the child is already using medicines such as high dose inhalers, but their asthma is not well controlled by these medicines. If the child is taking medicines called oral corticosteroids, Nucala can also help reduce the daily dose they need to control their asthma. Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5. By blocking the action of this protein, it limits the production of eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs. 2.

What you need to know before you take it

e Nucala

Do not use Nucala: if the child you are caring for is allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).

 Check with your doctor if you think this applies to the child. Warnings and precautions Talk to your doctor before using this medicine. Worsening asthma Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala.  Tell your doctor or nurse if the child's asthma remains uncontrolled, or gets worse, after starting Nucala treatment. Allergic and injection site reactions Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, 'Possible side effects'). If the child may have had a similar reaction to any injection or medicine:  Tell your doctor before you give Nucala. Parasitic infections Nucala may weaken the child's resistance to infections caused by parasites. If they already have a parasitic infection; it should be treated before they start treatment with Nucala. If they live in a region where these infections are common or if they are travelling to such a region:  Check with your doctor if you think any of these may apply to the child. Children and adolescents This medicine is not intended for use in children below 6 years of age. Other medicines and Nucala Tell your doctor if the child is taking, has recently taken or might take any other medicines. Other medicines for asthma

 Don't suddenly stop giving the child's preventer medicines for their asthma once they have

started Nucala. These medicines (especially ones called oral corticosteroids) must be stopped gradually, under the direct supervision of your doctor and dependent on their response to Nucala.

Pregnancy and breast-feeding Patients who are pregnant, think they may be pregnant or are planning to have a baby, must ask their doctor for advice before using this medicine. It is not known whether the ingredients of Nucala can pass into breast milk. Patients who are breast-feeding must check with their doctor before using Nucala. Driving and using machines The possible side effects of Nucala are unlikely to affect the ability to drive or use machines. Nucala contains polysorbate This medicine contains 0.08 mg of polysorbate per 40 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if the child has any known allergies. Nucala contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 40 mg dose, i.e., that is to say essentially "sodium-free". 3.

How to take it

Nucala

Nucala is given by injection just under the skin (subcutaneous injection). Your doctor or nurse will decide if you can inject Nucala for the child you are caring for. If appropriate, they will then provide training to show you the correct way to use Nucala. The recommended dose for children aged 6 to 11 years old is 40 mg. You will give 1 injection every four weeks. Instructions for using the pre-filled syringe are given on the other side of this leaflet. If you use more Nucala than you should If you think you have injected too much Nucala, contact your doctor for advice. If a dose of Nucala is missed You can inject the next dose of Nucala as soon as you remember. If you do not notice that you have missed a dose until it is already time to give the next dose, then just inject the next dose as planned. If you are not sure what to do, ask your doctor, pharmacist or nurse. Stopping treatment with Nucala Do not stop injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause the child's asthma symptoms and attacks to come back. If the child's asthma symptoms get worse while receiving injections of Nucala:  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. The side effects caused by Nucala are usually mild to moderate but can occasionally be serious. Allergic reactions Some people may have allergic or allergic-like reactions. These reactions may be common (they can affect up to 1 in 10 people). They usually occur within minutes to hours after the injection, but sometimes symptoms can start up to several days later. Symptoms can include: • chest tightness, cough, difficulty breathing • fainting, dizziness, feeling lightheaded (due to a drop in blood pressure) • swelling of eyelids, face, lips, tongue or mouth • hives • rash

 Seek medical attention immediately if you think the child may be having a reaction. If the child may have had a similar reaction to any injection or medicine:  Tell your doctor before the child is given Nucala Other side effects include: Very common: may affect more than 1 in 10 people

• headache Common: may affect up to 1 in 10 people
• chest infection – symptoms of which may include cough and fever (high temperature)
• urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
• upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
• fever (high temperature)
• eczema (itchy red patches on the skin)
• injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
• back pain
• arthralgia (joint pain)
• pharyngitis (sore throat)
• nasal congestion (stuffy nose) Uncommon: may affect up to 1 in 100 people
• herpes zoster (shingles) Rare: may affect up to 1 in 1,000 people
• Severe allergic reactions (anaphylaxis)  Tell your doctor or a nurse immediately if the child gets any of these symptoms. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 5.

How to store Nucala

Keep this medicine out of the sight and reach of children. Do not use Nucala 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 to 8°C). Do not freeze. Store in the original package in order to protect from light. The Nucala 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. Discard if left out of the refrigerator for more than 7 days. 6.

How to store it

Nucala

• • • •

Keep refrigerated before use. Do not freeze Keep the pre-filled syringe in the carton to protect from light. Keep out of the sight and reach of children.

• If necessary, the pre-filled syringe may be kept at room temperature, up to 30°C, for no more than 7 days, when stored in the original carton. Safely, throw the pre-filled syringe away if it has been kept out of the refrigerator for more than 7 days.
• Do not store it above 30°C. Before you use Nucala The pre-filled syringe must be used only once and then discarded.
• Do not share the Nucala pre-filled syringe with another person.
• Do not shake the syringe.
• Do not use the syringe if dropped onto a hard surface.
• Do not use the syringe if it appears damaged.
• Do not remove the needle cap until just before the injection.

Know the pre-filled syringe Before Use

After Use

White plunger White finger grip Stopper Inspection window (medicine inside) Automatic needle guard Needle cap inside)

(needle After use, the automatic needle guard is activated and pulls up (retracts) the needle

Prepare 1. Get ready what you need Find a comfortable, well-lit and clean surface. Make sure you have within reach:

• Nucala pre-filled syringe
• Alcohol wipe (not included)
• Gauze pad or cotton wool ball (not included)

2. Take out the pre-filled syringe Security seals

Peel off the plastic cover

Make sure the security seals are not broken

Take the syringe out of the tray

• Take the carton out of the refrigerator. Check the security seals are not broken.
• Remove the tray from the carton.
• Peel back the film cover from the tray.
• Holding the middle of the syringe, carefully take it out of the tray.
• Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children. Do not use the syringe if the security seal on the carton is broken. Do not remove the needle cap at this stage.

3. Inspect and wait 30 minutes before use

Exp: Month-Year

Check the expiry date

Check the medicine

Wait 30 minutes

• Check the expiry date on the label of the syringe.
• Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
• It is normal to see one or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.

Do not use if the expiry date has passed. Do not warm the syringe in a microwave, hot water, or direct sunlight. Do not inject if the solution looks cloudy or discoloured, or has particles. Do not use the syringe if left out of the carton for more than 8 hours. Do not remove the needle cap during this step.

4. Choose the injection site

Inject the child's upper arm or abdomen or thighs

• You can inject Nucala into the upper arm, abdomen or thigh of the child you are caring for. Do not inject where the skin is bruised, tender, red or hard. Do not inject within 5 cm of the navel (belly button).

5. Clean the injection site

• Wash your hands with soap and water.
• Clean the injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.

Do not touch the cleaned injection site again until you have finished the injection.

Inject 6. Remove the needle cap

Pull off the needle cap

• Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown). You may need to pull the needle cap quite firmly to remove it.

• Do not worry if you see a drop of liquid at the end of the needle. This is normal.
• Inject straight after removing the needle cap, and always within 5 minutes.

Do not let the needle touch any surface. Do not touch the needle. Do not touch the plunger at this stage, as you can accidentally push liquid out and will not give the full dose. Do not expel any air bubbles from the syringe. Do not put the needle cap back onto the syringe. This could cause a needle injury.

7. Start the injection

45°

Slowly push down

• Use your free hand to pinch the skin around the injection site. Keep the skin pinched throughout the injection.

• Insert the entire needle into the pinched skin at a 45° angle, as shown.
• Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
• Slowly push down on the plunger to inject the full dose. 8. Complete the injection

Make sure the white plunger is Slowly raise your thumb fully down

• Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
• Slowly lift your thumb up. This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
• Once complete, release the pinched skin.
• You may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
• Do not put the needle cap back onto the syringe.
• Do not rub the injection site.

Dispose

9. Dispose of the used syringe

• Dispose of the used syringe and needle cap according to local requirements. Ask your doctor or pharmacist for advice if necessary.

• Keep the used syringes and needle caps out of the sight and reach of children.

Contents of the pack and other information

What Nucala contains The active substance is mepolizumab. Each 0.4 mL pre-filled syringe contains 40 mg of mepolizumab. The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80 (E 433), disodium edetate, water for injections. What Nucala looks like and contents of the pack Nucala is supplied as a 0.4 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled syringe. Nucala is available in a pack containing 1 pre-filled syringe or in multipacks comprised of 3 x 1 pre-filled syringes. Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italy Or Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only) Please be ready to give the following information: Product name Nucala 40mg solution for injection in pre-filled syringe Reference number 19494/0303 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 03/2025 Trademarks are owned by or licenced to the GSK group of companies. © 2025 GSK group of companies or its licensor.

7. Step by step instructions for using the 40 mg pre-filled syringe Administer once every 4 weeks. Follow these instructions on how to use the pre-filled syringe. Failure to follow these instructions may affect proper function of the pre-filled syringe. You must also receive training on how to use the pre-filled syringe. Nucala pre-filled syringe is for use under the skin only (subcutaneous).