Nucala 40 mg solucion inyectable en jeringa precargada

Prospecto: information for the patient

Nucala 40mginjectable solution in pre-filled syringe

mepolizumab

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for the child in your care, and you must not give it to other people even if they have the same symptoms as the child in your care, as it may harm them.
• If the child experiences adverse effects, consult your doctor, pharmacist, or nurse even if they do not appear in this prospect. See section 4.

Nucala contains the active substancemepolizumab,amonoclonal antibody,a type of protein designed to recognize a specific target substance in the body. It is used to treatsevere asthmain adults, adolescents, and children aged 6 years and above.

Some people with severe asthma have too manyeosinophils(a type of white blood cell) in the blood and lungs. This condition is calledeosinophilic asthma– the type of asthma that Nucala can treat.

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

Mepolizumab, the active substance in Nucala, blocks a protein calledinterleukin-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 decreased.

No use Nucala:

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

• Consult with your doctorif you think this applies to the child.

Warnings and precautions

Consult your doctor before starting to use Nucala.

Worsening of asthma

Some people have asthma-related side effects, or their asthma may worsen during treatment withNucala.

• Consult with your doctor or nurseif the child's asthma remains uncontrolled, or worsens, after starting treatment with Nucala.

Allergic reactions and at the injection site

Medications of this type(monoclonal antibodies)can cause severe 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 medication:

• Consult with your doctorbefore administering Nucala.

Parasitic infections

Nucala may weaken the child's resistance to parasite-caused infections. If they already have a parasitic infection; it should be treated before starting treatment with Nucala. If they live in an area where these infections are common or if they are traveling to such an area:

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

Children and adolescents

This medication is not intended for use inchildren under 6 years old.

Other medications andNucala

Inform your doctorif the child is taking,has takenrecentlyor may need to take any other medication.

Other asthma medications

• Once treatment with Nucala has begun,do not stop giving the child their asthma-preventing medications suddenly. These medications (especially those calledoral corticosteroids) should be gradually discontinued under the direct supervision of your doctor and depending on the child's response to Nucala.

Pregnancy and breastfeeding

Pregnant patients, patients who think they may be pregnant, or patients who intend to become pregnant shouldconsult with their doctorbefore using this medication.

The components of Nucala are unknown to pass into breast milk.Pregnant patients should consult with their doctorbefore using Nucala.

Driving and operating machinery

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

Nucala contains sodium

This medication contains less than 1mmol of sodium (23mg) per 40mg; this is essentially “sodium-free”.

Nucalais administered through an injection just under the skin (subcutaneous injection).

Your doctor or nurse will decide if you can administer Nucala to the child in your care. If they consider it appropriate, you will receive training to use Nucala correctly.

The recommended dosefor children aged 6 to 11 yearsis 40mg.It will be administered 1 injection every four weeks.

You can find the Pre-filled Syringe Instructions for use on the other side of the leaflet.

If you use more Nucala than you should

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

If you forget a dose of Nucala

You must administer the next dose of Nucala as soon as you remember. If you do not realize you have forgotten a dose until it is time for the next one, administer only the next dose as planned. If you are unsure what to do, ask your doctor, pharmacist, or nurse.

If you interrupt treatment with Nucala

Do not stop administering Nucala injections unless your doctor tells you to. Stopping or interrupting treatment with Nucala may cause symptoms and asthma attacks to return in the child.

If the child's asthma symptoms worsen while receiving Nucala injections:

• Inform your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 allergic-type reactions. These reactions can be frequent (can affect up to 1 in 10 people). They usually occur within minutes to hours after the injection, but sometimes symptoms can start even several days later.

The symptoms may include:

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

• If you think the child is having a reactionseek medical attention immediately.

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

• Consult with your doctorbefore administering Nucala to the child.

Other side effects include:

Very common::can affect more than 1 in 10 people

• headache

Common:can affect up to 1 in 10 people

• chest infection whose symptoms may include cough and fever (elevated temperature)
• urinary tract infection (blood in urine, painful and frequent urination, fever, lower back pain)
• upper abdominal pain (stomach pain or discomfort in the upper stomach)
• fever (elevated temperature)
• eczema (red itchy patches on the skin)
• reactions at the injection site (pain, redness, swelling, itching, and burning sensation on the skin near the injection site)
• back pain
• arthralgia (joint pain)
• pharyngitis (sore throat)
• nasal congestion (stuffy nose)

Uncommon:can affect up to 1 in 100 people

• herpes zoster (herpes)

Rare:can affect up to1 in 1000people

• severe allergic reactions (anaphylaxis)

• If the child has any of these symptoms,consult your doctor or nurse immediately.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report themdirectlythrough thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label or on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Do not freeze.

Store in original packaging to protect it from light.

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

Composition of Nucala

The active ingredient is mepolizumab.

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

The other components are:sucrose, sodium phosphate dihydrate, citric acid monohydrate,polysorbate 80, disodium edetate,water for injection.

Appearance of the product and contents of the pack

Nucala is presented in a single-use pre-filled syringe as 0.4ml of a transparent to opalescent, colourless to pale yellow-brown solution.

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

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible for manufacturing

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 Authorisation Holder:

Last update of this leaflet:

Other sources of information

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

7. Step-by-step instructions for use of Nucala 40mg pre-filled syringe

Administer 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 only for useunder the skin(subcutaneously).

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

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

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