Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nucala

Document Subject

Generated Narrative: MedicinalProductDefinition mp701e93600aa20be1f78aef0a64b1f790

identifier: http://ema.europa.eu/identifier/EU/1/15/1043/003 1 pre-filled pen

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Nucala 100 mg solution for injection in pre-filled pen

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-701e93600aa20be1f78aef0a64b1f790

identifier: http://ema.europa.eu/identifier/EU/1/15/1043/003 1 pre-filled pen

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nucala

Attesters

7. Step-by-step instructions for use

What is in this leaflet

1. What Nucala is and what it is used for
2. What you need to know before you use Nucala
3. How to use Nucala
4. Possible side effects
5. How to store Nucala
6. Contents of the pack and other information

Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise 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) 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, it limits the production of eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs.

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 Nucala can treat.

Nucala can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines.
If you are taking medicines called oral corticosteroids, Nucala can 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 tissue lining the nose and sinuses. This can cause symptoms such as a blocked nose and loss of smell, and soft jelly-like growths (called nasal polyps) to form inside the nose.

Nucala reduces the number of eosinophils in the blood and can reduce the size of your polyps, relieves your nasal congestion and helps prevent surgery for nasal polyps.
Nucala can also help reduce the need for oral corticosteroids to control your symptoms.

Eosinophilic granulomatosis with polyangiitis (EGPA)

EGPA is a condition where people have too many eosinophils (a type of white blood cell) in the blood and tissues and also have a form of vasculitis. This means there is inflammation of the blood vessels. This condition most commonly affects the lungs and sinuses but often affects other organs such as the skin, heart and kidneys.

Nucala can control and delay a flare-up of these EGPA symptoms. This medicine can 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 are a high number of eosinophils (a type of 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 flares. If you are taking medicines often referred to as oral corticosteroids, Nucala can also help reduce the daily dose you need to control your HES symptoms/flares.

Do not use Nucala:

• if you are allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).

  Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before using this medicine.

Worsening asthma Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala. Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start Nucala treatment.

Allergic and injection site reactions Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, Possible side effects ).

If you may have had a similar reaction to any injection or medicine: Tell your doctor before you are given Nucala.

Parasitic infections Nucala may weaken your resistance to infections caused by parasites. If you already have a parasitic infection; it should be treated before you start treatment with Nucala. If you live in a region where these infections are common or if you are travelling to such a region:

Check with your doctor if you think any of these may apply to you. Children and adolescents

Severe eosinophilic asthma

The pre-filled pen is not intended for use in children below 12 years of age for the treatment of severe eosinophilic asthma. For children aged 6-11 years, contact your doctor who will prescribe the recommended dose of Nucala which will be administered by a nurse or doctor.

CRSwNP

This medicine is not intended for use in children or adolescents below 18 years of age for the treatment of CRSwNP.

EGPA

This medicine is not intended for use in children below 6 years of age for the treatment of EGPA.

HES

This medicine is not intended for use in adolescents or children below 18 years of age for the treatment of HES.

Other medicines and Nucala Tell your doctor if you are taking, have recently taken or might take any other medicines.

Other medicines for asthma, CRSwNP, EGPA or HES
Don t suddenly stop taking your existing medicines for your asthma, CRSwNP, EGPA or HES once you have started Nucala. These medicines (especially ones called oral corticosteroids) must be stopped gradually, under the direct supervision of your doctor and dependent on your response to Nucala.

Pregnancy and breast-feeding
If you are pregnant, if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

It is not known whether the ingredients of Nucala can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Nucala.

Driving and using machines
The possible side effects of Nucala are unlikely to affect your ability to drive or use machines.

Nucala contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e., that is to say essentially sodium-free .

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

Your doctor or nurse will decide if you or your caregiver can inject Nucala. If appropriate, they will then provide training to show you or your caregiver the correct way to use Nucala. Nucala must be given to children aged 6 to 11 years by a doctor, nurse or trained caregiver.

Severe eosinophilic asthma

The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will have 1 injection every four weeks.

CRSwNP

The recommended dose for adults is 100 mg. You will have 1 injection every four weeks.

EGPA

The recommended dose for adults and adolescents aged 12 years and older is 300 mg. You will have 3 injections every four weeks.

Children aged 6 to 11 years old

Children weighing 40 kg or more: The recommended dose is 200 mg. You will have 2 injections every four weeks.

Children weighing less than 40 kg:
The recommended dose is 100 mg. You will have 1 injection every four weeks.

The injection sites should be at least 5 cm apart.

HES

The recommended dose for adults is 300 mg. You will have 3 injections every four weeks.

The injection sites should be at least 5 cm apart.

Instructions for using the pre-filled pen are given on the other side of this leaflet.

If you use more Nucala than you should If you think you have injected too much Nucala, contact your doctor for advice.

If a dose of Nucala is missed
You or your caregiver should inject the next dose of Nucala as soon as you remember. If you do not notice that you have missed a dose until it is already time for your next dose, then just inject the next dose as planned. If you are not sure what to do, ask your doctor, pharmacist or nurse.

Stopping treatment with Nucala
Do not stop injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause your symptoms and attacks to come back.

If your symptoms get worse while receiving injections of Nucala
Call your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Nucala are usually mild to moderate but can occasionally be serious.

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

Symptoms can include:

• chest tightness, cough, difficulty breathing
• fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
• swelling of eyelids, face, lips, tongue or mouth
• hives
• rash

Seek medical attention immediately if you think you (or your child) may be having a reaction.

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

Tell 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 - symptoms of which may include cough and fever (high temperature)
• urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
• upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
• fever (high temperature)
• eczema (itchy red patches on the skin)
• injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
• back pain
• pharyngitis (sore throat)
• nasal congestion (stuffy nose)

Rare:
may affect up to 1 in 1 000 people

• severe allergic reactions (anaphylaxis)

  Tell your doctor or a nurse immediately if you get any of these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use Nucala after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C).

Do not freeze.

Store in the original package in order to protect from light.

The Nucala pre-filled pen can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30 C), when protected from light. Discard if left out of the refrigerator for more than 7 days.

What Nucala contains The active substance is mepolizumab.

Each 1 mL pre-filled pen contains 100 mg of mepolizumab. The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for injections.

What Nucala looks like and contents of the pack

Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled pen.

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

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: + 370 52 691 lt@berlin-chemie.com

• / .
  E
  Te .: + 359 2 454 0bcsofia@berlin-chemie.com

Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: + 36 23501bc-hu@berlin-chemie.com

Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Trading Services Ltd. Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti O Berlin-Chemie Menarini Eesti Tel: + 372 667 5ee@berlin-chemie.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com
Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 office-croatia@berlin-chemie.com

Rom nia GlaxoSmithKline Trading Services Ltd.
Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: + 386 (0)1 300 2slovenia@berlin-chemie.com

sland Vistor hf. S mi: + 354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: + 421 2 544 30 slovakia@berlin-chemie.com

Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline Trading Services Ltd. : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija SIA Berlin-Chemie/Menarini Baltic Tel: + 371 67103lv@berlin-chemie.com

United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Ltd. Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: