Nucala 100 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Nucala 100 mg solution for injection in pre-filled syringe

mepolizumab

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Nucala is and what it is used for
2. What you need to know before using Nucala
3. How to use Nucala
4. Possible side effects
5. How to store Nucala
6. Contents of the pack and other information
7. 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 substance in the body. It is used to treat severe asthma and EGPA (Eosinophilic Granulomatosis with Polyangiitis) in adults, adolescents, and children aged 6 years and older. It is also used to treat CRSwNP (Chronic Rhinosinusitis with Nasal Polyps), COPD (Chronic Obstructive Pulmonary Disease), and HES (Hypereosinophilic Syndrome) in adults.

Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5. By blocking the action of this protein, the production of eosinophils by the bone marrow is limited, and the number of eosinophils in the blood and lungs is reduced.

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 called eosinophilic asthma – the type of asthma that Nucala can treat.

If you or your child are already using high-dose inhaled medications, but your 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 you need to control your asthma.

Chronic rhinosinusitis with nasal polyps (CRSwNP)

CRSwNP is a condition in which people have too many eosinophils (a type of white blood cell) in the blood and in the tissues lining the nose and sinuses. This can cause 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 nasal polyps, relieving nasal congestion and helping to prevent surgery for nasal polyps.

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

Chronic Obstructive Pulmonary Disease (COPD)

Some people with COPD have too many eosinophils (a type of white blood cell) in the blood and lungs, leading to inflammation and thickening of the airways. It is a chronic disease that slowly worsens. Symptoms include difficulty breathing, cough, chest discomfort, and production of mucus. Nucala reduces the number of eosinophils in the blood and may decrease exacerbations (flare-ups) of COPD 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 sinuses, but often affects other organs such as the skin, heart, and kidneys.

Nucala can control or delay a flare-up of these EGPA symptoms. This medicine may also help reduce the daily dose of oral corticosteroids you need to control your 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 your symptoms and prevents flare-ups. If you are taking medications commonly known as oral corticosteroids, Nucala may also help reduce the daily dose you need to control your HES symptoms and flare-ups.

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).

• Consult your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor before starting to use this medicine.

Worsening of asthma or COPD

Some people may experience adverse effects related to asthma or COPD, or their asthma or COPD may worsen during treatment with Nucala.

• Consult your doctor or nurse if your asthma or COPD remains uncontrolled or worsens after starting treatment with Nucala.

Allergic 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 ever had a reaction similar to any injection or medication:

• Consult your doctor before Nucala is administered to you.

Parasitic infections

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

• Consult your doctor if you think either of these situations applies to you.

Children and adolescents

Severe eosinophilic asthma

The pre-filled syringe is not indicated for use in children under 12 years of age for 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.

EGPA, COPD and HES

This medicine is not indicated for use in children or adolescents under 18 years of age for the treatment of EGPA, COPD or HES.

EGPA

This medicine is not indicated 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 need to take any other medicines.

Other medicines for asthma, EGPA, COPD, EGPA or HES

• Once you have started treatment with Nucala, do not stop suddenly taking the medicines you were using to prevent your asthma, EGPA, COPD, EGPA or HES. These medicines (especially those known as oral corticosteroids) should be discontinued gradually, under the direct supervision of your doctor and depending on your response to Nucala.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is unknown 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

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

Nucala contains polysorbate

This medicine contains 0.2 mg of polysorbate in each 100 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Nucala contains sodium

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

3. How to use Nucala

Nucala is administered by injection just under the skin (subcutaneous injection).

Your doctor or nurse will decide whether you or your caregiver can inject Nucala. If considered appropriate, you or your caregiver will receive training on how to use Nucala correctly.

In children aged 6 to 11 years, Nucala must be administered by a doctor, nurse, or a trained caregiver.

Severe eosinophilic asthma

Recommended dose in adults and adolescents aged 12 years and older is 100 mg. One injection will be given every four weeks.

RSCcPN

Recommended dose in adults is 100 mg. One injection will be given every four weeks.

COPD

Recommended dose in adults is 100 mg. One injection will be given every four weeks.

EGPA

Recommended dose in adults and adolescents aged 12 years and older is 300 mg. Three injections will be given every four weeks.

Children aged 6 to 11 years

Children weighing 40 kg or more:

Recommended dose is 200 mg. Two injections will be given every four weeks.

Children weighing less than 40 kg:

Recommended dose is 100 mg. One injection will be given every four weeks.

Injection sites should be at least 5 cm apart.

HES

Recommended dose in adults is 300 mg. Three injections will be given every four weeks.

Injection sites should be at least 5 cm apart.

Instructions for using the pre-filled syringe are provided at the end of this leaflet.

If you use more Nucala than you should

Contact your doctor if you think you may have administered too much Nucala.

If you forget a dose of 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 time for the next scheduled 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. Interrupting or stopping treatment with Nucala may cause your symptoms and attacks to return.

If your symptoms worsen while you are receiving Nucala injections:

• Inform your doctor.

If you have any further questions about 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 everyone gets them. The side effects caused by Nucala are generally mild to moderate, although occasionally they can be severe.

Allergic reactions

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

Symptoms may include:

• tightness in the chest, cough, difficulty breathing

• fainting, dizziness, feeling faint (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) may be having a reaction, seek immediate medical attention.

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

• Consult your doctor before 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 with symptoms such as cough and fever (high temperature)
• urinary tract infection (blood in urine, painful and frequent urination, fever, lower back pain)
• herpes zoster (shingles)
• upper abdominal pain (stomach pain or discomfort in the upper stomach)
• fever (high temperature)
• eczema (itchy red patches on the skin)
• injection site reaction (pain, redness, swelling, itching, and burning sensation at or near the injection site)
• back pain
• arthralgia (joint pain)
• pharyngitis (sore throat)
• nasal congestion (stuffy nose)

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

• severe allergic reactions (anaphylaxis)

• If you experience 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 it is a possible side effect 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 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 stated on the label or packaging following EXP. The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Keep in the original packaging to protect from light.

The Nucala pre-filled pen may be removed from the refrigerator and stored in the outer packaging, unopened, for up to 7 days at room temperature (below 30 °C), protected from light. Discard if left outside the refrigerator for more than 7 days.

6. Contents of the pack and other information

Composition of Nucala

The active substance is mepolizumab.

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

The other components are: sucrose, disodium phosphate heptahydrate, monohydrate citric acid, polysorbate 80 (E 433), disodium edetate, water for injections.

Appearance of the product and contents of the pack

Nucala is presented in a single-use pre-filled syringe as 1 ml of a solution ranging from transparent to opalescent, from colourless to pale yellow to pale brown.

Nucala is available in a pack containing 1 pre-filled syringe, or in a multiple pack 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
D24 YK11
Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.P.A
Strada Provinciale Asolana, No 90
43056 San Polo di Torrile, Parma
Italy

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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

Administration once every four 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. The Nucala pre-filled syringe is for subcutaneous (under the skin) use only.

How to store Nucala

• Keep refrigerated before use.

• Do not freeze.

• Store 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 may be kept at room temperature, below 30 °C, for no more than 7 days, provided it is stored in the original packaging. Carefully discard the syringe if it has been kept outside the refrigerator for more than 7 days.

• Store below 30 °C.

Before using Nucala

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

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