Nucala 100 mg solucion inyectable en jeringa precargada

Prospect: Information for the Patient

Nucala 100mgInjectable 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 questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

7. Step-by-Step Instructions for Use

Nucala contains the active substancemepolizumab, a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. It is used to treat severe asthma andEGPA(Eosinophilic Granulomatosis with Polyangiitis) in adults, adolescents, and children aged 6 years and older. It is also used to treatCRSwNP(Chronic Rhinosinusitis with Nasal Polyps) andHS(Hypereosinophilic Syndrome) in adults.

Mepolizumab, the active substance of 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.

Severe eosinophilic asthma

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 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 calledoral 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 manyeosinophils(a type of white blood cell) in the blood, in the tissues that cover 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, alleviating nasal congestion and helping to prevent nasal polyp surgery.

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

Eosinophilic granulomatosis with polyangiitis (EGPA)(GEPA)

GEPA is a disease in which people have too manyeosinophils(a type of white blood cell) in the blood and tissues and also have some form ofvasculitis. 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 of these symptoms of GEPA. This medication may also help reduce the daily dose oforal corticosteroidsyou need to control your symptoms.

Hypereosinophilic syndrome (HES)

The hypereosinophilic syndrome (HES) is a disease in which there is an elevated number ofeosinophils(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 flares. If you are taking medications commonly known asoral corticosteroids, Nucala may also help reduce the daily dose you need to control your symptoms and flares of HES.

No use Nucala:

• if you areallergicto 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.

Worsening of asthma

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

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

Allergic reactions and at the injection site

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 medication:

• Consult your doctorbefore Nucala is administered to you.

Parasitic infections

Nucala may weaken your resistance to parasite-caused infections. If you already have a parasitic infection, you should be treated before starting Nucala treatment. 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 inchildren 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, which will be administered by a nurse or doctor.

RSCcPN

This medication is not indicated for useinchildren or adolescents under 18 yearsfor the treatment of RSCcPN.

GEPA

This medication is not indicated for use inchildren under 6 yearsfor the treatment of GEPA.

SHE

This medication is not indicated for use inadolescents or children under 18 yearsfor the treatment of SHE.

Other medications and Nucala

Inform your doctorif you are taking,have takenrecentlyor may need to take any other medication.

Other asthma, RSCcPN, GEPA or SHE medications

• Once you have started treatment with Nucala,do not stop takingyour asthma, RSCcPN, GEPA or SHEmedications suddenly. These medications (especially the ones calledoral corticosteroids) should be gradually discontinued 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 intend to become pregnant,consult your doctorbefore using this medication.

The components of Nucala are unknown to pass into breast milk.If you are breastfeeding, you must consult your 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 1 mmol of sodium (23 mg) per 100 mg; this is essentially “sodium-free”.

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

Your doctor or nurse will decide if you or your caregiver can administer 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 the doctor, nurse, or a trained caregiver.

Severe eosinophilic asthma

Recommended dosein adults and adolescents 12 years of age and older is 100 mg. It will be administered as an injection every four weeks.

RSCcPN

Recommended dosein adults is 100mg.It will be administered 1 injection every four weeks.

GEPA

Recommended dosein adultsand adolescents 12 years of age and older is 300mg.It will be administered 3 injections every four weeks.

Children 6 to 11 years of age

Children weighing40 kg or more:

Recommended doseis 200 mg. It will be administered 2 injections every four weeks.

Children weighing less than40 kg:

Recommended doseis 100 mg.It will be administered 1 injection every four weeks.

The injection sites must be at least 5 cm apart.

SHE

Recommended dosein adults is 300 mg. It will be administered 3 injections every four weeks.

The injection sites must be at least 5 cm apart.

You can find the Instructions for use of the pre-filled syringe 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 miss a dose of Nucala

You or your caregiver must administer 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 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 receiving Nucala injections unless your doctor tells you to. Stopping or discontinuing 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 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, sensation of dizziness (due to a drop in blood pressure)
• swelling of the eyelids, face, lips, tongue, or mouth
• hives
• eruption

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

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

• Consult with your doctorbefore Nucala is administered to you (or your 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 10,000people

• severe allergic reactions (anaphylaxis)

• If you have 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 the 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 1 ml of the pre-filled syringe contains 100 mg of mepolizumab.

The other components are:sucrose, sodium phosphate dibasic heptahydrate, 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 1 ml 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 or 9 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Last update of this leaflet:

Other sources of information

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

7. Step-by-step instructions for use of Nucala 100 mg 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 subcutaneous use.

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 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.

Before using Nucala

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 onto a hard surface..
• Do notuse the pre-filled syringe if it appears to be damaged..
• Do notremove the needle cap until just before injection.n.