NUCALA 100 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Nucala 100mginjectable solution in pre-filled pen

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 medications such as high-dose inhalers, but your asthma is not well controlled by these medications, Nucala may reduce the number of asthma attacks. If you are taking medications 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 the 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 the 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 an outbreak of these EGPA symptoms. This medication 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 body's organs, particularly the heart, lungs, nerves, and skin.

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

2. What you need to know before you use Nucala

Do not use Nucala:

• if you are allergicto mepolizumab or any of the other components of this medication (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 adverse 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

Medications 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 medication:

• Consult your doctorbefore you are administered 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 one of these areas:

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

Children and adolescents

Severe eosinophilic asthma

The pre-filled pen 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 medication is not indicated for use in children or adolescents under 18 yearsfor the treatment of CRSwNP.

EGPA

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

HES

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

Other medications and Nucala

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

Other medications for asthma, CRSwNP, EGPA, or HES

• Once you have started treatment with Nucala, do not suddenly stop takingthe medications you were taking to prevent your asthma, CRSwNP, EGPA, or HES. These medications (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 plan to become pregnant, consult your doctorbefore using this medication.

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

3. How to use Nucala

Nucala is administered via an 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. An injection will be given every four weeks.

CRSwNP

The recommended dosein adults is 100 mg. 1 injection will be given every four weeks.

EGPA

The recommended dosein adults and adolescents from 12 years is 300 mg. 3 injections will be given every four weeks.

Children from 6 to 11 years of age

Children who weigh40kg or more:

The recommended doseis 200 mg. 2 injections will be given every four weeks.

Children who weigh less than40kg:

The recommended doseis 100 mg. 1 injection will be given every four weeks.

The injection sites should be at least 5 cm apart.

HES

The recommended dosein adults is 300 mg. 3 injections will be given 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 pen.

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 the next dose, administer only the next dose as planned. If you are unsure 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 return.

If your symptoms worsen while you are receiving Nucala injections:

• Tell your doctor.

If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them. The side effects caused by Nucala are generally mild to moderate, although they can occasionally 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 medication:

• Consult your doctorbefore you (or your child) are administered 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 patches that itch 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 have 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 them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nucala

Keep this medication out of the sight and reach of children.

Do not use this medication 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 packaging to protect from light.

The Nucala pre-filled pen 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 pen 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 pen as 1 ml of a clear to opalescent, colorless to pale yellow-brown solution.

Nucala is available in a pack containing 1 pre-filled pen, or in a multipack 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

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 medicinal product by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

Other sources of information

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

1. Step-by-step instructions for using the pre-filled pen

Administration once every 4 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 should also receive training on how to use the pre-filled pen. Nucala pre-filled pen is for subcutaneous use only.

How to store Nucala

• Keep refrigerated before use.
• Do not freeze.
• Keep the pre-filled pen in the original packaging to protect it from light.
• Keep out of sight and reach of children.
• If necessary, the pre-filled pen can be kept at room temperature, below 30 °C, for no more than 7 days, if kept in the original packaging. Carefully discard the pen if it is left out of the refrigerator for more than 7 days.
• Store below 30 °C.

Before using Nucala

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

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