NUCALA 100 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Nucala 100mginjectable solution in pre-filled syringe

mepolizumab

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 doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Nucala and what is it used for
2. What you need to know before you use Nucala
3. How to use Nucala
4. Possible side effects
5. Storage of Nucala
6. Contents of the pack and other information

1. Step-by-step instructions for use

1. What is Nucala and what is it used for

Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. It is used to treat severe asthma and EGPA(Eosinophilic Granulomatosis with Polyangiitis) in adults, adolescents, and children from 6 years of age. It is also used to treat CRSwNP(Chronic Rhinosinusitis with Nasal Polyps) and HES(Hypereosinophilic Syndrome) in adults.

Mepolizumab, the active substance of 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 decreases 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 their 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 medicines such as high-dose inhalers, but your asthma is not well controlled by these medicines, Nucala may reduce the number of asthma attacks. If you are taking medicines called oral corticosteroids, Nucala may also help reduce the daily dose you need to control your asthma.

Chronic rhinosinusitis with nasal polyps (CRSwNP)

CRSwNP is a disease in which people have too many eosinophils(a type of white blood cell) in their blood, in the tissues that line the nose, and in the nasal sinuses. This can produce symptoms such as nasal congestion and loss of smell, as well as soft, gelatinous growths (called nasal polyps) that form inside the nose.

Nucala reduces the number of eosinophils in the blood and may reduce the size of your polyps, relieving nasal congestion and helping to prevent nasal polyp surgery.

Nucala may also help reduce the need for oral corticosteroidsto control your symptoms.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

EGPA is a disease in which people have too many eosinophils(a type of white blood cell) in their blood and tissues, and also have some form of vasculitis. This means there is inflammation in the blood vessels. This disease most commonly affects the lungs and nasal sinuses, but often affects other organs such as the skin, heart, and kidneys.

Nucala may control or delay a flare-up of these EGPA symptoms. This medicine may also help reduce the daily dose of oral corticosteroidsyou need to control your symptoms.

Hypereosinophilic Syndrome (HES)

Hypereosinophilic Syndrome (HES) is a disease in which there is a high number of eosinophils(a type of white blood cell) in the blood. These cells can damage the organs of the body, particularly the heart, lungs, nerves, and skin.

Nucala helps reduce your symptoms and prevents flare-ups. If you are taking medicines known as oral corticosteroids, Nucala may also help reduce the daily dose of these you need to control your symptoms and HES flare-ups.

2. What you need to know before you use Nucala

Do not use Nucala:

• if you are allergicto mepolizumab or any of the other ingredients of this medicine (listed in section 6).

• Consult your doctorif you think this applies to you.

Warnings and precautions

Consult your doctor before starting to use Nucala.

Asthma worsening

Some people have side effects related to asthma, or their asthma may worsen during treatment with Nucala.

• Consult your doctor or nurseif your asthma remains uncontrolled or worsens after starting treatment with Nucala.

Allergic reactions 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 you have ever had a similar reaction to any injection or medicine:

• Consult your doctorbefore you are given Nucala.

Parasitic infections

Nucala may weaken your resistance to parasitic infections. If you already have a parasitic infection, it should be treated before starting treatment with Nucala. If you live in an area where these infections are common or if you are traveling to such an area:

• Consult your doctorif you think any of these circumstances apply to you.

Children and adolescents

Severe eosinophilic asthma

The pre-filled syringe is not indicated for use in children under 12 yearsfor the treatment of severe eosinophilic asthma.

For children aged 6-11 years, consult your doctor who will prescribe the recommended dose of Nucala to be administered by a nurse or doctor.

CRSwNP

This medicine is not indicated for use in children or adolescents under 18 yearsfor the treatment of CRSwNP.

EGPA

This medicine is not indicated for use in children under 6 yearsfor the treatment of EGPA.

HES

This medicine is not indicated for use in adolescents or children under 18 yearsfor the treatment of HES.

Other medicines and Nucala

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

Other medicines for asthma, CRSwNP, EGPA, or HES

• Once you have started treatment with Nucala, do not stop takingyour medicines for preventing asthma, CRSwNP, EGPA, or HES suddenly. These medicines (especially those called oral corticosteroids) should be stopped gradually, under the direct supervision of your doctor and depending on your response to Nucala.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctorbefore using this medicine.

It is not known whether the components of Nucala can pass into breast milk. If you are breastfeeding, consult your doctorbefore using Nucala.

Driving and using machines

It is unlikely that the possible side effects of Nucala will affect your ability to drive or use machines.

Nucala contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 100 mg; this is essentially “sodium-free”.

3. How to use Nucala

Nucala is given by injection just under your skin (subcutaneous injection).

Your doctor or nurse will decide if you or your caregiver can inject Nucala. If they consider it appropriate, you or your caregiver will receive training to use Nucala correctly.

In children between 6 and 11 years of age, Nucala must be administered by a doctor, nurse, or trained caregiver.

Severe eosinophilic asthma

The recommended dosein adults and adolescents from 12 years is 100 mg. It is given as one injection every four weeks.

CRSwNP

The recommended dosein adults is 100 mg. It is given as one injection every four weeks.

EGPA

The recommended dosein adults and adolescents from 12 years is 300 mg. It is given as three injections every four weeks.

Children aged 6 to 11 years

Children who weigh40 kg or more:

The recommended doseis 200 mg. It is given as two injections every four weeks.

Children who weigh less than40 kg:

The recommended doseis 100 mg. It is given as one injection every four weeks.

The injection sites should be at least 5 cm apart.

HES

The recommended dosein adults is 300 mg. It is given as three injections every four weeks.

The injection sites should be at least 5 cm apart.

On the other side of the leaflet, you can find the Instructions for use of the pre-filled syringe.

If you use more Nucala than you should

Consult your doctorif you think you may have administered too much Nucala.

If you miss a dose of Nucala

You or your caregiver should inject the next dose of Nucala as soon as you remember. If you do not realize you have missed a dose until it is time for your next dose, just inject the next dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

If you stop treatment with Nucala

Do not stop receiving Nucala injections unless your doctor tells you to. Stopping or interrupting treatment with Nucala may cause your symptoms and attacks to come back.

If your symptoms worsen while you are receiving Nucala injections:

• Tell 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 generally mild to moderate, although occasionally they can be severe.

Allergic reactions

Some people may have allergic reactions or reactions of an allergic type. These reactions can be common (they can affect up to 1 in 10 people). They usually occur within minutes to hours after the injection, but sometimes the symptoms can start even several days later.

The symptoms can include:

• chest tightness, cough, difficulty breathing
• fainting, dizziness, feeling of dizziness (due to a drop in blood pressure)
• swelling of the eyelids, face, lips, tongue, or mouth
• hives
• rash

• If you think you (or your child) are having an allergic reaction, seek medical attention immediately.

If you have ever had a similar reaction to any injection or medicine:

• Consult your doctorbefore you (or your child) are 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, whose symptoms can include cough and fever (high temperature)
• urinary tract infection (blood in the urine, painful and frequent urination, fever, pain in the lower back)
• upper abdominal pain (stomach pain or discomfort in the upper abdomen)
• fever (high temperature)
• eczema (red, itchy patches on the skin)
• injection site reactions (pain, redness, swelling, itching, and burning sensation in the skin near the injection site)
• 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)

• If you get any of these symptoms, consult your doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of Nucala

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 or carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original package to protect from light.

The Nucala pre-filled syringe can be removed from the refrigerator and stored in the outer carton without opening for up to 7 days at room temperature (below 30°C) and protected from light. Discard if left out of the refrigerator for more than 7 days.

6. Container contents and additional information

Nucala Composition

The active ingredient is mepolizumab.

Each 1 ml of the pre-filled syringe contains 100 mg of mepolizumab.

The other components are: sucrose, disodium phosphate heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for injectable preparations.

Appearance of the product and container contents

Nucala is presented in a single-use pre-filled syringe as 1 ml of a clear to opalescent, colorless to pale yellow-brown solution.

Nucala is available in a pack containing 1 pre-filled syringe, or in a multipack containing 3 x 1 pre-filled syringes or 9 x 1 pre-filled syringes.

Marketing Authorization Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, No 90

43056 San Polo di Torrile, Parma

Italy

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Date of last revision of this leaflet:

Other sources of information

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

1. Step-by-step instructions for using Nucala 100 mg pre-filled syringe

Administration once every 4 weeks.

Follow these instructions on how to use the pre-filled syringe. Failure to follow these instructions may affect the proper functioning of the pre-filled syringe. You should also receive training on how to use the pre-filled syringe. Nucala pre-filled syringe is for subcutaneous use only.

How to store Nucala

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

• If necessary, the pre-filled syringe can be kept at room temperature, below 30 °C for no more than 7 days, if kept in the original packaging. Carefully discard the syringe if it is left out of the refrigerator for more than 7 days.

• Keep below 30 °C.

Before using Nucala

The pre-filled syringe should be used only once and then discarded.

• Do notshare your pre-filled syringe with another person.
• Do notshake the syringe.
• Do notuse the syringe if it falls on a hard surface.
• Do notuse the syringe if it appears to be damaged.
• Do notremove the needle cap until just before injection.