mepolizumab: package leaflet

Find a comfortable, well-lit and clean surface. Make sure you have within reach:
• Nucala pre-filled pen
• Alcohol wipe (not included)
• Gauze pad or cotton wool ball (not included)
Clear needle cap
Before use
After use
Label
Stopper
Inspection window
(medicine inside)
Yellow needle guard
(needle inside)
Yellow indicator
(becomes visible when the injection is complete)

• Take the carton out of the refrigerator. Check the security seals are not broken.
• Remove the required number of trays from the carton.
• Place any remaining trays in the original carton back into the refrigerator.
• Peel back the film cover from the tray.
• Holding the middle of the pen, carefully take it out of the tray.
• Place the pen on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
Do not use the pen if the security seal on the carton is broken.
Do not remove the needle cap at this stage.
Security seals
Make sure the security seals are not broken
Peel off the plastic cover
Take the pen out of the tray

• Check the expiry date on the label of the pen.
• Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
• It is normal to see one or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.

Do not use if the expiry date has passed.
Do not warm the pen in a microwave, hot water, or direct sunlight.
Do not inject if the solution looks cloudy or discoloured, or has particles.
Do not use the pen if left out of the carton for more than 8 hours.
Do not remove the needle cap during this step.

• You can inject Nucala into your thighs or abdomen.
Check the expiry date
Check the medicine
Wait 30 minutes
Exp: Month-Year
Inject yourself in thighs or abdomen
Alternatively, another person can inject in your upper arm

• If someone else gives you the injection, they can also use your upper arm.
• If you need more than one injection to complete your dose, then leave at least 5 cm between each injection site.
Do not inject where your skin is bruised, tender, red or hard.
Do not inject within 5 cm of your navel (belly button).

• Wash your hands with soap and water.
• Clean your injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Do not touch your injection site again until you have finished your injection.
Inject

Pull off the clear needle cap

• Remove the clear needle cap from the pen by firmly pulling it straight off.
• Do not worry if you see a drop of liquid at the end of the needle. This is normal.
• Inject straight after removing the needle cap, and always within 5 minutes.
Do not touch the yellow needle guard with your fingers. This could activate the pen too soon and may cause a needle injury.
After removal, do not put the needle cap back onto the pen, as it may accidentally start the injection.
7. Start your injection
• Hold the pen with its inspection window facing towards you, so you can see it, and with the yellow needle guard facing down.
• Place the pen straight onto your injection site with the yellow needle guard flat against the surface of your skin, as shown.
• To start your injection, push the pen down all the way and keep it held down against your skin. The yellow needle guard will slide up into the pen.
• You should hear the 1st “click” to tell you your injection has started.
• The yellow indicator will move down through the inspection window as you receive your dose.
Do not lift the pen from your skin at this stage, as that may mean you don’t get your full dose of medicine. Your injection may take up to 15 seconds to complete.
Do not use the pen if the yellow needle guard doesn’t slide up as described. Dispose of it (see Step 9), and start again with a new pen.
Inspection window
Needle guard
Press down
1st
“Click”

8. Hold the pen in place to complete your injection

• Continue to hold the pen down until you hear the 2nd “click”, and the stopper and yellow indicator have stopped moving and fill the inspection window.
• Continue to hold the pen in place while you count to 5. Then lift the pen away from your skin.
• If you do not hear the 2nd “click”:
– Check that the inspection window is filled with the yellow indicator.
– If you are not sure, hold the pen down for another 15 seconds to make sure the injection is complete.
Do not lift the pen until you are sure you have completed your injection.
• You may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
Do not rub your injection site.
Dispose
9. Dispose of the used pen
• Dispose of the used pen and needle cap according to local requirements. Ask your doctor or pharmacist for advice if necessary.
• Keep your used pens and needle caps out of the sight and reach of children.

2nd
“Click”
Continue to hold down as you count to 5, then lift off

Find a comfortable, well-lit and clean surface. Make sure you have within reach:
• Nucala pre-filled syringe
• Alcohol wipe (not included)
• Gauze pad or cotton wool ball (not included)
Before use
After use
After use, the automatic needle guard is activated and pulls up
(retracts) the needle.
Automatic needle guard
Inspection window
(medicine inside)
Stopper
White finger grip
White plunger
Needle cap
(needle inside)

• Take the carton out of the refrigerator. Check the security seals are not broken.
• Remove the required number of trays from the carton.
• Place any remaining trays in the original carton back into the refrigerator.
• Peel back the film cover from the tray.
• Holding the middle of the syringe, carefully take it out of the tray.
• Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
Do not use the syringe if the security seal on the carton is broken.
Do not remove the needle cap at this stage.

• Check the expiry date on the label of the syringe.
Security seals
Make sure the security seals are not broken
Peel off the plastic cover
Take the syringe out of the tray
Check the expiry date
Check the medicine
Wait 30 minutes
Exp: Month-Year

• Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
• It is normal to see one or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.

Do not use if the expiry date has passed.
Do not warm the syringe in a microwave, hot water, or direct sunlight.
Do not inject if the solution looks cloudy or discoloured, or has particles.
Do not use the syringe if left out of the carton for more than 8 hours.
Do not remove the needle cap during this step

• You can inject Nucala into your thighs or abdomen.
• If someone else gives you the injection, they can also use your upper arm.
• If you need more than one injection to complete your dose, then leave at least 5 cm between each injection site.
Do not inject where your skin is bruised, tender, red or hard.
Do not inject within 5 cm of your navel (belly button).
Inject yourself in thighs or abdomen
Alternatively, another person can inject in your upper arm

• Wash your hands with soap and water.
• Clean your injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Do not touch your injection site again until you have finished your injection.
Inject

• Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown). You may need to pull the needle cap quite firmly to remove it.
• Do not worry if you see a drop of liquid at the end of the needle. This is normal.
• Inject straight after removing the needle cap, and always within 5 minutes.
Pull off the needle cap

Do not let the needle touch any surface.
Do not touch the needle.
Do not touch the plunger at this stage, as you can accidentally push liquid out and will not receive your full dose.
Do not expel any air bubbles from the syringe.
Do not put the needle cap back onto the syringe. This could cause a needle injury.
7. Start your injection

• Use your free hand to pinch the skin around your injection site. Keep the skin pinched throughout your injection.
• Insert the entire needle into the pinched skin at a 45° angle, as shown.
• Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
• Slowly push down on the plunger to inject your full dose.
8. Complete your injection

Slowly push down
Make sure the white plunger is fully down
Slowly raise your thumb

• Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
• Slowly lift your thumb up. This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
• Once complete, release the pinched skin.
• You may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
• Do not put the needle cap back onto the syringe.
• Do not rub your injection site.
Dispose
9. Dispose of the used syringe
• Dispose of the used syringe and needle cap according to local requirements. Ask your doctor or pharmacist for advice if necessary.
• Keep your used syringes and needle caps out of the sight and reach of children.

Find a comfortable, well-lit and clean surface. Make sure you have within reach:
• Nucala pre-filled syringe
• Alcohol wipe (not included)
• Gauze pad or cotton wool ball (not included)
White plunger
White finger grip
Stopper
Inspection window
(medicine inside)
Automatic needle guard
Needle cap
(needle inside)
After use, the automatic needle guard is activated and pulls up (retracts) the needle

• Take the carton out of the refrigerator. Check the security seals are not broken.
• Remove the tray from the carton.
• Peel back the film cover from the tray.
• Holding the middle of the syringe, carefully take it out of the tray.
• Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
Do not use the syringe if the security seal on the carton is broken.
Do not remove the needle cap at this stage.

Exp: Month-Year
Wait 30 minutes
Check the medicine
Check the expiry date
Security seals
Make sure the security seals are not broken
Peel off the plastic cover
Take the syringe out of the tray

• Check the expiry date on the label of the syringe.
• Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
• It is normal to see one or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.
Do not use if the expiry date has passed.
Do not warm the syringe in a microwave, hot water, or direct sunlight.
Do not inject if the solution looks cloudy or discoloured, or has particles.
Do not use the syringe if left out of the carton for more than 8 hours.
Do not remove the needle cap during this step.

• You can inject Nucala into the upper arm, abdomen or thigh of the child you are caring for.
Do not inject where the skin is bruised, tender, red or hard.
Do not inject within 5 cm of the navel (belly button).

• Wash your hands with soap and water.
Inject the child’s upper arm or abdomen or thighs

• Clean the injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Do not touch the cleaned injection site again until you have finished the injection.
Inject

• Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown). You may need to pull the needle cap quite firmly to remove it.
• Do not worry if you see a drop of liquid at the end of the needle. This is normal.
• Inject straight after removing the needle cap, and always within 5 minutes.
Do not let the needle touch any surface.
Do not touch the needle.
Do not touch the plunger at this stage, as you can accidentally push liquid out and will not give the full dose.
Do not expel any air bubbles from the syringe.
Do not put the needle cap back onto the syringe. This could cause a needle injury.

7. Start the injection

• Use your free hand to pinch the skin around the injection site. Keep the skin pinched throughout the injection.
Pull off the needle cap
45°
Slowly push down

• Insert the entire needle into the pinched skin at a 45° angle, as shown.
• Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
• Slowly push down on the plunger to inject the full dose.
8. Complete the injection

• Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
• Slowly lift your thumb up. This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
• Once complete, release the pinched skin.
• You may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
• Do not put the needle cap back onto the syringe.
• Do not rub the injection site.

Dispose
9. Dispose of the used syringe
• Dispose of the used syringe and needle cap according to local requirements. Ask your doctor or pharmacist for advice if necessary.
• Keep the used syringes and needle caps out of the sight and reach of children.

Make sure the white plunger is fully down
Slowly raise your thumb

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), 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, 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.

Chronic obstructive pulmonary disease (COPD)

Some people with COPD have too many eosinophils (a type of white blood cell) in the blood and lungs, causing the airways to become inflamed and thickened. It is a long-term condition that slowly gets worse. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Nucala reduces the number of eosinophils in the blood and can reduce flare-ups of COPD 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 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 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 or COPD
Some people get asthma-related or COPD-related side effects, or their asthma or COPD may become worse, during treatment with Nucala.
➔ Tell your doctor or nurse if your asthma or COPD 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

Severe eosinophilic asthma and EGPA

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

CRSwNP, COPD and HES

This medicine is not intended for use in children or adolescents below 18 years of age for the treatment of CRSwNP, COPD or 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, COPD, EGPA or HES
 Don’t suddenly stop taking your existing medicines for your asthma,CRSwNP, COPD, 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 polysorbate
This medicine contains 0.74 mg of polysorbate per 100 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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 to you by a doctor, nurse or healthcare professional, as an injection just under the skin (subcutaneously).

Severe eosinophilic asthma

Adults and adolescents aged 12 years and over

The recommended dose for adults and adolescents is 100 mg. You will be given 1 injection every four weeks.

Children aged 6 to 11 years old

The recommended dose is 40 mg. You will be given 1 injection every four weeks.

CRSwNP

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

COPD

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

EGPA

Adults and adolescents aged 12 years and over

The recommended dose for adults and adolescents is 300 mg. You will be given 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 be given 2 injections every four weeks.

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

The injection sites must be at least 5 cm apart.

HES

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

The injection sites must be at least 5 cm apart.

If a dose of Nucala is missed

Contact your doctor or hospital as soon as possible to re-schedule your appointment.

Stopping treatment with Nucala
Do not stop receiving 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 (or your child) 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)
- herpes zoster (shingles)
- 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
- arthralgia (joint 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 below 25C.
Do not freeze.
Store in the original package to protect from light.

What Nucala contains
The active substance is mepolizumab. Each vial contains 100 mg of mepolizumab.
After reconstitution, each mL of solution contains 100 mg mepolizumab.

The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80 (E 433).

What Nucala looks like and contents of the pack

Nucala is a lyophilised white powder supplied in a clear, colourless glass vial with a rubber stopper.

Nucala is available in a pack containing 1 vial, or in multipacks with 3 individual vials.

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

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Lietuva
UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tel: + 370 52 691 947 lt@berlin-chemie.com

България
“Берлин-Хеми/А. Менарини
България” EООД
Teл.: + 359 2 454 0950 bcsofia@berlin-chemie.com

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com
Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: + 36 23501301 bc-hu@berlin-chemie.com

Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
GlaxoSmithKline Trading Services Ltd.
Tel: + 356 80065004
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: + 372 667 5001 ee@berlin-chemie.com

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700 es-ci@gsk.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44 diam@gsk.com

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
FI.PT@gsk.com
Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: +385 1 4821 361 office-croatia@berlin-chemie.com

România
GlaxoSmithKline Trading Services Ltd.
Tel: + 40 800672524
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
Berlin-Chemie / A. Menarini Distribution
Ljubljana d.o.o.
Tel: + 386 (0)1 300 2160 slovenia@berlin-chemie.com

Ísland
Vistor ehf.
Sími: + 354 535 7000

Slovenská republika
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o.
Tel: + 421 2 544 30 730 slovakia@berlin-chemie.com

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Ltd.
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: + 371 67103210 lv@berlin-chemie.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:
https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

7.
Step-by-step instructions for use and handling, reconstitution, and administration

Nucala is provided as a lyophilised, white powder in a single-use vial for subcutaneous injection only.
Reconstitution must be carried out under aseptic conditions.

Once reconstituted, Nucala will contain a concentration of 100 mg/mL mepolizumab. The solution for injection can be stored between 2C to 30C for no more than 8 hours. Any unused concentrate or solution remaining after 8 hours must be discarded.

Traceability

In order to improve traceability of the biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Instructions for reconstitution for each vial

1.
Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2 to 3 mL syringe and a 21 gauge needle. The stream of sterile water must be directed vertically, onto the centre of the lyophilised cake. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.

Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation. Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time.

2.
If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450 rpm for no longer than 10 minutes. Alternatively, swirling at 1 000 rpm for no longer than 5 minutes is acceptable.
3.
Following reconstitution, Nucala must be visually inspected for particulate matter and clarity prior to use. The solution must be clear to opalescent, and colourless to pale yellow or pale brown, free of visible particles. Small air bubbles, however, are expected and acceptable. If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be used.
4.
The reconstituted solution, if not used immediately must be:
- Protected from sunlight
- Stored below 30°C, not frozen
- Discarded if not used within 8 hours of reconstitution

Instructions for administration of 100 mg dose

1.
For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
2.
Just prior to administration, remove 1 mL of reconstituted Nucala from one vial. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation.
3.
Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

If more than one vial is required for administration of the prescribed dosage, repeat steps 1 to 3. It is recommended that individual injection sites are separated by at least 5 cm.

Instructions for administration of 40 mg dose

1.
For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
2.
Just prior to administration, remove 0.4mL of reconstituted Nucala. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation. Dispose of the remaining solution.
3.
Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.