Nucala 40 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Nucala 40 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for the child under your care. Do not give it to other people, even if they have the same symptoms as the child under your care, as it may harm them.
• If the child experiences any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions 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 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 that Nucala can treat.

If a child is already using medications such as high-dose inhalers, but their asthma is not well controlled with these medications, Nucala may reduce the number of asthma attacks. If a child is taking medications called oral corticosteroids, Nucala may also help reduce the daily dose needed to control their asthma.

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.

2. What you need to know before starting Nucala

Do not use Nucala:

• if the child in your care is allergic to mepolizumab or to any of the other components of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor before starting this medicine.

Worsening of asthma

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

• Consult your doctor or nurse if the child's asthma 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 the child has ever had a similar reaction to any injection or medicine:

• Consult your doctor before administering 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 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 circumstances applies to the child.

Children and adolescents

This medicine is not intended for use in children under 6 years of age.

Other medicines and Nucala

Tell your doctor if the child is taking, has recently taken, or might need to take any other medicines.

Other asthma medicines

• Once treatment with Nucala has started, do not suddenly stop giving the child the asthma-preventing medicines they were previously taking. These medicines (especially those called oral corticosteroids) should be discontinued gradually, under the direct supervision of your doctor and depending on the child's response to Nucala.

Pregnancy and breastfeeding

Patients who are pregnant, think they might be pregnant, or plan to become pregnant should consult their doctor before using this medicine.

It is unknown whether the components of Nucala can pass into breast milk. Patients who are breastfeeding should consult their 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 operate machinery.

Nucala contains polysorbate

This medicine contains 0.08 mg of polysorbate in each 40 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 40 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 may inject Nucala for the child in your care. If they consider it appropriate, you will receive training on how to use Nucala correctly.

The recommended dose for children aged 6 to 11 years is 40 mg. One injection will be administered every four weeks.

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

If you use more Nucala than you should

Consult your doctor if you think that too much Nucala may have been administered.

If you forget a dose of Nucala

You may inject 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 administering Nucala injections unless your doctor tells you to. Interrupting or stopping treatment with Nucala may cause asthma symptoms and attacks to return in the child.

If the child's asthma symptoms worsen while 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The adverse effects caused by Nucala are generally mild to moderate, although they can occasionally 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:

• chest tightness, cough, difficulty breathing

• fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)

• swelling of the eyelids, face, lips, tongue, or mouth

• hives

• rash

• If you think the child may be having a reaction, seek immediate medical attention.

If the child has ever had a similar reaction to any injection or medicine:

• Consult your doctor before administering Nucala to the child.

Other adverse 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 (elevated temperature)
• urinary tract infection (blood in urine, painful and frequent urination, fever, pain in the lower back)
• pain in the upper abdomen (stomach pain or discomfort in the upper stomach)
• fever (elevated temperature)
• eczema (itchy red patches on the skin)
• injection site reaction (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 the child experiences any of these symptoms, consult your doctor or nurse immediately.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 container after 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 syringe may be removed from the refrigerator and stored in its unopened outer packaging 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 container and other information

Composition of Nucala

The active substance is mepolizumab.

Each 0.4 ml of the pre-filled syringe contains 40 mg of mepolizumab.

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

Appearance of the product and contents of the container

Nucala is presented in a single-use pre-filled syringe as 0.4 ml of a solution ranging from clear to opalescent and from colourless to pale yellow to pale brown.

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

For further information about this medicine, please contact 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 medicinal product 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 Health Products (AEMPS) (http://www.aemps.gob.es/).

1. Step-by-step instructions for using Nucala 40 mg pre-filled syringe

Administer 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 use only.

• 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 left outside the refrigerator for more than 7 days.
• Store below 30 °C.

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 onto a hard surface.
• Do not use the syringe if it appears damaged.
• Do not remove the needle cap until just before your injection.