Nucala: detailed information

Package leaflet: Information for the user

Nucala 100 mg solution for injection in pre-filled pen

mepolizumab
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.
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 this leaflet:

What Nucala is and what it is used for
What you need to know before using Nucala
How to use Nucala
Possible side effects
How to store Nucala
Contents of the pack and other information
Step-by-step instructions for using the pen

1. What Nucala is and what it is used for

Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to
recognize a specific target in the body. It is used to treat severe asthma and
Eosinophilic Granulomatosis with Polyangiitis ( EGPA ) in adults, adolescents, and children aged 6 years and older. It is also used to treat chronic rhinosinusitis with nasal polyposis (CRSwNP),
chronic obstructive pulmonary disease ( COPD ), and Hypereosinophilic Syndrome ( HES ) in adults.
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 by the bone marrow and
reduces the number of eosinophils in the blood and lungs.
Severe eosinophilic asthma
Some people with severe asthma have too many eosinophils (a type of white blood cells) in the blood and lungs.
This condition is called eosinophilic asthma – the type of asthma that Nucala can treat.
If you or your child are already using medications such as high-dose inhalers, but asthma is not well
controlled by these medications, Nucala can reduce the number of asthma attacks.
If you are taking medications called oral corticosteroids, Nucala may also help reduce the daily dose
of oral corticosteroids needed to control asthma.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a condition in which people may have high
levels of eosinophils (a type of white blood cells) in the blood and excess tissue lining the nose and
sinuses. This can cause symptoms such as nasal congestion, loss of smell, and the formation of soft, gelatinous growths inside the nose (called nasal polyps). Nucala reduces the number of eosinophils in the blood and
can reduce the size of nasal polyps, relieve nasal congestion, and help prevent surgery to remove nasal polyps. Nucala may also help reduce the need for oral corticosteroids to control symptoms.
Chronic obstructive pulmonary disease (COPD)
Some people with COPD have an excessive number of eosinophils (a type of white blood cells) in the blood and
lungs, which cause inflammation and thickening of the airways. This is a long-term condition that slowly worsens. Symptoms include shortness of breath, cough, chest tightness, and cough with sputum. Nucala reduces the number of eosinophils in the blood and may reduce exacerbations of COPD symptoms.
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
EGPA is a condition in which people have too many eosinophils (a type of white blood cells) in the blood and
tissues and also have a form of vasculitis. This means there is inflammation of the blood vessels. This condition most commonly affects the lungs and sinuses, but often involves other organs such as the skin, heart, and kidneys.
Nucala can control and delay a relapse of these EGPA symptoms. This medicine may also help reduce the daily dose of oral corticosteroids needed to control symptoms.
Hypereosinophilic Syndrome (HES)
Hypereosinophilic Syndrome (HES) is a condition in which there is a high number of eosinophils (a type of white blood cells) in the blood. These cells can damage organs of the body, particularly the heart, lungs, nerves, and skin. Nucala helps reduce symptoms and prevent relapses. If you are taking medications often referred to as oral corticosteroids, Nucala may also help reduce the daily dose required to control HES symptoms/relapses.

2. What you need to know before using Nucala

Do not use Nucala

if you are allergic to mepolizumab or to any of the other ingredients of this medicine (listed in section 6). → Check with your doctor if this applies to you.

Warnings and precautions
Talk to your doctor before using Nucala.
Worsening of asthma or COPD
Some people may develop asthma- or COPD-related side effects, or may experience worsening of asthma during treatment with Nucala.
→ Tell your doctor or nurse if your asthma or COPD remains uncontrolled or worsens after starting treatment with Nucala.
Allergic reactions and injection site reactions
Medicines of this type (monoclonal antibodies) can cause serious allergic reactions when injected into the body (see section 4, “Possible side effects”).
If you have had such a reaction to injections or medicines before,
→ Tell your doctor before being given Nucala.
Parasitic (helminth) infections
Nucala may reduce your body’s ability to fight infections caused by parasites. If you already have a parasitic infection, it must be treated before starting treatment with Nucala. If you live in or travel to areas where such infections are common:
→ Check with your doctor if you think this may apply to you.
Children and adolescents
Severe eosinophilic asthma
The pre-filled pen is not intended for use in children under 12 years of age for the treatment of severe eosinophilic asthma.
For children aged 6 to 11 years, contact your doctor, who will prescribe the recommended dose of Nucala, to be administered by a nurse or doctor.
CRSwNP, COPD and HES
This medicine is not intended for use in children and adolescents under 18 years of age for the treatment of CRSwNP, COPD or HES.
EGPA
This medicine is not intended for use in children under 6 years of age for the treatment of EGPA.

Other medicines and Nucala
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Other medicines for asthma, CRSwNP, COPD, EGPA or HES
Do not suddenly stop taking your current medicines for asthma, CRSwNP, COPD, EGPA or HES once you start treatment with Nucala. These medicines (especially those called oral corticosteroids) should be tapered gradually under the direct supervision of your doctor, depending on your response to Nucala.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this medicine.
It is not known whether the components of Nucala can pass into breast milk. If you are breastfeeding, you must consult your doctor before using Nucala.
Driving and using machines
The possible side effects of Nucala are unlikely to affect your ability to drive or operate machinery.
Nucala contains polysorbate
This medicine contains 0.2 mg of polysorbate per 100 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Nucala contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 100 mg dose, i.e. essentially “sodium-free”.

3. How to use Nucala

Nucala is administered by subcutaneous injection (subcutaneous injection).
Your doctor or nurse will decide whether you or a caregiver may inject Nucala. If appropriate, they will provide training to show you or your caregiver the correct way to use Nucala.
Nucala must be administered to children aged 6 to 11 years by a doctor, nurse, or qualified healthcare provider.

Severe eosinophilic asthma
The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will receive 1 injection every four weeks.

CRSwNP
The recommended dose in adults is 100 mg. You will receive 1 injection every four weeks.

COPD
The recommended dose in adults is 100 mg. You will receive 1 injection every four weeks.

EGPA
The recommended dose for adults and adolescents aged 12 years and older is 300 mg. You will receive 3 injections every four weeks.

Children aged 6 to 11 years
Children weighing 40 kg or more:
The recommended dose is 200 mg. You will receive 2 injections every four weeks.
Children weighing less than 40 kg:
The recommended dose is 100 mg. You will receive 1 injection every four weeks.
Injection sites must be at least 5 cm apart.

HES
The recommended dose for adults is 300 mg. You will receive 3 injections every 4 weeks.
Injection sites must be at least 5 cm apart.

Instructions for use of the pre-filled pen are provided on the reverse side of this patient information leaflet.

If you use more Nucala than you should
If you think you have injected too much Nucala, contact your doctor for advice.

If you forget to use Nucala
You or your caregiver may administer the next dose of Nucala as soon as you remember. If you do not realize a dose has been missed until it is already time for the next scheduled dose, simply administer the next dose as planned. If you are unsure what to do, ask your doctor, pharmacist, or nurse.

If you stop using Nucala
Do not stop the course of Nucala injections unless instructed by your doctor. Stopping or interrupting treatment with Nucala may cause symptoms and exacerbations to return.

If your symptoms worsen during treatment with Nucala injections
→ Contact your doctor.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects caused by Nucala are generally mild to moderate, but occasionally they can be severe.

Allergic reactions
Some people may experience allergic or allergy-like reactions. These reactions can be common (may affect up to 1 in 10 people). They usually occur within minutes or hours after the injection, but sometimes symptoms may start several days later.
Symptoms may include:

chest tightness, cough, difficulty breathing
fainting, dizziness, feeling lightheaded (due to low blood pressure)
swelling of the eyelids, face, lips, tongue or mouth
hives
skin rash

→ If you think that you (or your child) may be having such a reaction, seek immediate medical help.
If you (or your child) have previously had such a reaction to injections or medicines,
→ Tell your doctor before Nucala is administered.

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 infections – symptoms may include cough and fever (raised body temperature)
urinary tract infections (blood in urine, pain and frequent urination, fever, pain in lower back)
herpes zoster (shingles)
pain in the upper abdomen (stomach ache or discomfort in the upper part of the stomach)
fever (raised body temperature)
eczema (itchy red patches on the skin)
injection site reaction (pain, redness, swelling, itching, burning sensation of the skin near the area where the injection was given)
back pain
arthralgia (joint pain)
pharyngitis (sore throat)
nasal congestion (blocked nose)

Rare:
may affect up to 1 in 1,000 people

severe allergic reactions (anaphylaxis)

→ Tell your doctor or nurse immediately if you experience any of these symptoms.

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

5. How to store Nucala

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following "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 the medicine from light.
The Nucala pre-filled pen may be removed from the refrigerator and stored in its unopened packaging
for up to 7 days at room temperature (up to 30°C), provided it is protected from light. Discard if left
outside the refrigerator for more than 7 days.

6. Package contents and other information

What Nucala contains
The active substance is mepolizumab.
Each 1 mL pre-filled pen contains 100 mg of mepolizumab.
The other components are sucrose, disodium phosphate heptahydrate, citric acid monohydrate, polysorbate
80 (E 433), disodium edetate, water for injections.

Description of the appearance of Nucala and contents of the pack
Nucala is supplied as a 1 mL solution, from clear to opalescent, colourless to pale yellow or pale brown, in a single-use pre-filled pen.
Nucala is available in a pack containing 1 pre-filled pen, or in multiple packs containing 3 x 1 pre-filled pens or 9 x 1 pre-filled pens.

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 San Polo di Torrile, Parma
Italy

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

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 52 691 947
[email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини GlaxoSmithKline Pharmaceuticals s.a./n.v.
България” EООД Belgique/Belgien
Teл.: + 359 2 454 0950 Tél/Tel: + 32 (0) 10 85 52 00
[email protected]

Česká republika Magyarország
GlaxoSmithKline, s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: + 420 222 001 111 Tel.: + 36 23501301
[email protected] [email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Ltd.
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti GlaxoSmithKline AS
Tel: + 372 667 5001 Tlf: + 47 22 70 20 00
[email protected]

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. GlaxoSmithKline Trading Services Ltd.
Tel: +385 1 4821 361 Tel: + 40 800672524
[email protected]

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited Berlin-Chemie / A. Menarini Distribution
Tel: + 353 (0)1 4955000 Ljubljana d.o.o.
Tel: + 386 (0)1 300 2160
[email protected]

Ísland Slovenská republika
Vistor ehf. Berlin-Chemie / A. Menarini Distribution
Sími: + 354 535 7000 Slovakia s.r.o.
Tel: + 421 2 544 30 730
[email protected]

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Ltd. GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: + 371 67103210
[email protected]

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

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

How to store Nucala

Store in the refrigerator before use.
Do not freeze.
Keep the pre-filled pen in the original packaging to protect from light.
Keep out of the sight and reach of children.
If necessary, the pre-filled pen may be stored at room temperature, up to 30°C, for no more than 7 days, provided it is kept in the original packaging. For safety, discard the pre-filled pen if it has been stored outside the refrigerator for more than 7 days.
Do not store above 30°C.

Before using Nucala
The pre-filled pen must be used only once and then discarded.

Do not share the Nucala pre-filled pen with another person.
Do not shake the pen.
Do not use the pen if it falls on a hard surface.
Do not use the pen if it appears damaged.
Do not remove the needle cap until just before injection.

Getting to know the pre-filled pen

Technical diagram of two medical injection pens with reference lines indicating the different parts of the device and the liquid level

Label
Lock
Yellow indicator (becomes visible when injection is complete)
Prepare

1. Prepare the necessary items

Find a comfortable, well-lit, and clean surface.
Make sure you have the following items within reach:

Nucala pre-filled pen
Alcohol wipe (not included)
Gauze pad or cotton ball (not included)

2. Remove the pre-filled pen

Diagram showing how to open the package and remove the drug container using two hands and orange directional arrows

Safety seals
Make sure the safety seals are intact
Remove the pen from the tray

Remove the package from the refrigerator. Check that the safety seals are not broken.
Remove the tray from the box.
Peel off the covering film from the tray.
Holding the pen by the middle, carefully remove it from the tray.
Place the pen on a clean, flat surface at room temperature, away from direct sunlight and out of the reach of children. Do not use the pen if the safety seal on the box is broken. Do not remove the needle cap at this stage.

3. Inspect and wait 30 minutes before use

Medical diagram showing a white auto-injector device with an enlargement of the viewing window and a

Wait 30
minutes

Check the expiration date on the pen label.
Look through the inspection window to ensure the liquid is clear (free from cloudiness or particles) and colorless to pale yellow or pale brown.
It is normal to see one or more air bubbles.
Wait 30 minutes (but no longer than 8 hours) before use. Do not use if the expiration date has passed. Do not heat the pen in a microwave, hot water, or direct sunlight. Do not inject if the solution appears cloudy, discolored, or contains particles. Do not use the pen if it has been left outside the cardboard case for more than 8 hours. Do not remove the needle cap during this step.

4. Choose the injection site

Human body diagram with green zones on the arms and orange areas on the

Inject it
yourself in the
thighs or abdomen

You may inject Nucala in the thighs or abdomen.
If someone else administers the injection, the upper arm may also be used.
If more than one injection is needed to complete the dose, leave at least 5 cm between each injection site. Do not inject where the skin is bruised, soft, red, or hard. Do not inject within 5 cm of the navel.

5. Clean the injection site

Two illustrations show hands washing with water and soap and one hand applying a bandage to an orange skin area

Wash 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 injection site again until the injection has been completed.

Injecting

6. Remove the transparent needle cap

A hand holding a white medical device while the

Remove the transparent needle cap from the pen by pulling it off firmly.
Do not be concerned if a drop of liquid appears at the tip of the needle. This is normal.
Inject immediately after removing the needle cap and always within 5 minutes. Do not touch the yellow needle guard with your fingers. This could activate the pen too early and cause a needle stick injury. After removal, do not reattach the needle cap to the pen, as this could accidentally start the injection.

7. Start the injection

Two illustrations show a hand holding a white medical device for a

Inspection
window
First
Needle guard
“Click”
of the needle

Hold the pen with the inspection window facing towards you so you can see it, and with the yellow needle guard pointing downward.
Place the pen directly onto the injection site with the yellow needle guard perpendicular to the skin surface, as shown.
To start the injection, push the pen downward fully and keep it pressed against the skin. The yellow needle guard will retract into the pen.
You should hear the first "click," indicating that the injection has started.
The yellow indicator will move downward across the inspection window as your dose is delivered. Do not lift the pen away from the skin at this stage, as this could result in not receiving the full dose of medicine. The injection may take up to 15 seconds to complete. Do not use the pen if the yellow needle guard does not retract as described. Dispose of it (see step 9) and start again with a new pen.

8. Keep the pen in place to complete the injection

Two illustrations show a hand pressing an injection pen against the skin with a downward arrow and lifting it away with an upward arrow

Continue
pushing down
while counting
to 5, then lift
Second
“Click”
2nd “Click”

Keep holding the pen down until you hear the 2nd “click” and until the cap and yellow indicator have stopped moving and completely filled the inspection window.
Keep holding the pen in place and count to 5. Then remove the pen from the skin.
If you do not hear the 2nd “click”:
- Check that the inspection window is completely filled by the yellow indicator.
- If you are unsure, hold the pen down for an additional 15 seconds to ensure the injection is complete. Do not lift the pen until you are certain the injection has been completed.
You may notice a small drop of blood at the injection site. This is normal. Press a cotton ball or gauze pad on the area for a few seconds if needed. Do not rub the injection site.

Disposal

9. Disposal of the used pen

Dispose of the used pen and needle cap according to local regulations. Ask your doctor or pharmacist for advice, if necessary.
Keep used pens and needle caps out of sight and reach of children.

Package leaflet: information for the user

Nucala 100 mg solution for injection in pre-filled syringe

mepolizumab
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, ask your doctor, pharmacist, or nurse.
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:

What Nucala is and what it is used for
What you need to know before using Nucala
How to use Nucala
Possible side effects
How to store Nucala
Contents of the pack and other information
Step-by-step instructions for use

1. What Nucala is and what it is used for

Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to
recognize a specific target in the body. It is used for the treatment of severe asthma and
Eosinophilic Granulomatosis with Polyangiitis ( EGPA ) in adults, adolescents, and children aged 6 years and older. It is also used to treat chronic rhinosinusitis with nasal polyposis (CRSwNP),
chronic obstructive pulmonary disease (COPD), and hypereosinophilic syndrome ( HES ) in adults.
Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5.
By blocking the action of this protein, it limits the overproduction of eosinophils by the bone marrow and reduces the number of eosinophils in the blood and lungs.
Severe eosinophilic asthma
Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs.
This condition is known as eosinophilic asthma – the type of asthma that Nucala can treat.
If you or your child are already using medications such as high-dose inhalers, but asthma is not well
controlled by these medications, Nucala can reduce the number of asthma attacks.
If you are taking medications called oral corticosteroids, Nucala may also help reduce the daily dose of oral corticosteroids needed to control asthma.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a condition in which people may have high levels of eosinophils (a type of white blood cell) in the blood and excess tissue lining the nose and sinuses. This can cause symptoms such as nasal blockage, loss of smell, and the formation of gelatinous growths inside the nose (called nasal polyps). Nucala reduces the number of eosinophils in the blood and can reduce the size of nasal polyps, relieve nasal congestion, and help prevent surgical removal of nasal polyps. Nucala may also help reduce the need for oral corticosteroids to control symptoms.
Chronic obstructive pulmonary disease (COPD)
Some people with COPD have an excessive number of eosinophils (a type of white blood cell) in the blood and lungs, causing inflammation and thickening of the airways. This is a long-term condition that worsens slowly. Symptoms include breathlessness, cough, chest tightness, and cough with sputum production. Nucala reduces the number of eosinophils in the blood and may reduce the frequency of COPD symptom exacerbations.
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
EGPA is a condition in which people have too many eosinophils (a type of white blood cell) in the blood and tissues and also have a form of vasculitis. This means there is inflammation of the blood vessels. This condition most commonly affects the lungs and sinuses, but often involves other organs such as the skin, heart, and kidneys.
Nucala can control and delay a recurrence of these EGPA symptoms. This medicine may also help reduce the daily dose of oral corticosteroids needed to control symptoms.
Hypereosinophilic syndrome (HES)
Hypereosinophilic syndrome (HES) is a condition in which there is a high number of eosinophils (a type of white blood cell) in the blood. These cells can damage organs in the body, particularly the heart, lungs, nerves, and skin. Nucala helps reduce symptoms and prevents relapses. If you are taking medications commonly referred to as oral corticosteroids, Nucala may also help reduce the daily dose required to control HES symptoms and relapses.

2. What you need to know before using Nucala

Do not use Nucala

if you are allergic to mepolizumab or to any of the other ingredients of this medicine (listed in section 6). → Check with your doctor if this applies to you.

Other medicines and Nucala
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Other medicines for asthma, CRSwNP, COPD, EGPA or HES
Do not stop suddenly taking your current medicines for asthma, CRSwNP, COPD, EGPA or HES once you have started treatment with Nucala. These medicines (especially those called oral corticosteroids ) must be tapered gradually under the direct supervision of your doctor, depending on your response to Nucala.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
It is not known whether the components of Nucala pass into breast milk. If you are breastfeeding, you must consult your doctor before using Nucala.
Driving and using machines
The possible side effects of Nucala are unlikely to affect your ability to drive or use machines.
Nucala contains polysorbate
This medicine contains 0.2 mg of polysorbate per 100 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Nucala contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) in a 100 mg dose, i.e. essentially “sodium-free”.