Neulasta

Package leaflet: Information for the user

Neulasta 6 mg solution for injection

pegfilgrastim
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Neulasta is and what it is used for

Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using biotechnology in a bacterial cell called Escherichia coli. It belongs to a group of proteins known as cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.
Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with fever) that may be caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important because they help the body fight infections. These cells are highly sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells in the body. If the white blood cell count drops to a low level, there may not be enough cells left to fight bacteria, and you may be at increased risk of developing an infection.
Your doctor has prescribed Neulasta to stimulate the bone marrow (the part of the bone responsible for blood cell production) to produce more white blood cells, helping your body to fight infections.

2. What you should know before using Neulasta

Do not use Neulasta

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Neulasta:

• if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness, skin rash, and itchy areas of skin.
• if you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.
• if you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you experience one or more of the following side effects:
  • swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These could be symptoms of a condition called "Capillary Leak Syndrome," which causes blood to leak from small blood vessels in the body. See section 4.
• if you have pain in the upper left side of the abdomen or shoulder tip pain. These could be signs of a problem with the spleen (splenomegaly).
• if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal X-ray finding (pulmonary infiltration).
• if you know you have abnormal blood cell counts (e.g. elevated white blood cells or anemia) or a low platelet count, which reduces the body's ability to clot (thrombocytopenia). Your doctor may wish to monitor you closely.
• if you have sickle cell anemia. Your doctor may wish to monitor you closely.
• if you have breast cancer or lung cancer, Neulasta in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
• if you suddenly develop signs of allergy such as skin rash, hives, or itching, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing—these could be signs of a severe allergic reaction.
• if you have symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), which has been reported rarely in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Inform your doctor if such symptoms occur.

Your doctor will regularly monitor your blood and urine, as Neulasta may damage the tiny filters in your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Neulasta. If you notice any of the symptoms described in section 4, stop using Neulasta and seek immediate medical attention.
You should discuss with your doctor the risks of developing a blood cancer. If you have or may have a blood cancer, you must not use Neulasta unless otherwise directed by your doctor.

Loss of response to pegfilgrastim
If you experience a reduced response or failure to maintain a response to treatment with pegfilgrastim, your doctor will investigate the reasons, including the possibility that you have developed antibodies that neutralize the activity of pegfilgrastim.

Other medicines and Neulasta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been studied in pregnant women. It is important that you inform your doctor if:

• you are pregnant;
• you suspect you may be pregnant; or
• you are planning a pregnancy.

Unless otherwise advised by your doctor, you must stop breastfeeding while using Neulasta.

Driving and using machines
Neulasta does not affect or has a negligible effect on the ability to drive or operate machinery.

Neulasta contains sorbitol (E420) and sodium
This medicine contains 30 mg of sorbitol per pre-filled syringe, equivalent to 50 mg/mL.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e., essentially 'sodium-free'.

3. How to use Neulasta

Neulasta is intended for adults aged 18 years or older.
Always take Neulasta exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is one subcutaneous injection (injection under the skin) of 6 mg, which must be administered at least 24 hours after the last dose of chemotherapy, at the end of each chemotherapy cycle.
How to self-administer the Neulasta injection
Your doctor may consider it appropriate for you to self-administer the Neulasta injection. Your doctor or nurse will show you how to inject Neulasta. Do not attempt to inject yourself unless you have been properly instructed.
Refer to the section at the end of this leaflet for instructions on how to self-administer the Neulasta injection.

Neulasta alone.

Do not shake Neulasta vigorously, as this may impair its activity.
If you use more Neulasta than you should
If you use more Neulasta than you should, you must contact your doctor, pharmacist, or nurse.
If you forget your Neulasta injection
If you perform the self-injection and have forgotten your dose of Neulasta, you must contact your doctor to determine when to administer the next injection.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you experience any one or a combination of the following side effects:

• swelling or puffiness, which may be associated with reduced urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly.

These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called "Capillary Leak Syndrome", which causes blood to leak from small blood vessels into the body and requires urgent medical treatment.

Very common side effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will advise you on what to take to relieve bone pain.
• nausea and headache.

Common side effects (may affect up to 1 in 10 people):

• pain at the injection site.
• general pain and joint and muscle aches.
• some blood changes may occur, but these will be detected during routine blood tests. White blood cell levels may rise temporarily. Platelet levels may decrease, leading to bruising.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic-type reactions, including flushing and hot flushes, skin rash (redness of the skin), and skin swellings with itching.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• rupture of the spleen. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you feel pain in the upper left part of the abdomen or in the left shoulder, as this may indicate spleen problems.
• breathing problems. If you have cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet’s syndrome (purple-coloured, raised and painful skin lesions on limbs and sometimes on the face and neck, associated with fever) have been reported, although other factors may have contributed.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters within the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (haemoptysis).
• blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
• bleeding from the lungs (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which may present with reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals and eyes, and which may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Neulasta and contact your doctor or seek immediate medical assistance. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Neulasta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
You may remove Neulasta from the refrigerator and keep it at room temperature (not above 30°C) for
no more than 3 days. Once the syringe has been removed from the refrigerator and has reached room
temperature (not above 30°C), it must be used within 3 days or must be discarded.
Do not freeze. Neulasta may be used if it has been accidentally frozen once for less than 24 hours.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice it is cloudy or if particles are visible.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Neulasta Contains

• The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.
• The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections. See section 2.

Description of the Appearance of Neulasta and Contents of the Package
Neulasta is a clear, colourless injectable solution in a pre-filled syringe (6 mg/0.6 mL).
Each pack contains 1 glass pre-filled syringe with a stainless steel needle and needle cap.
The pre-filled syringe (with or without blister packaging) may be supplied with an automatic needle protection device.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen Technology Ireland (ADL)
Pottery Road
Dun Laoghaire
Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474

България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700

Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf: +45 39617500 Italy
Tel: +39 02 6241121

Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel.: +49 89 1490960 Tel: +31 (0)76 5732500

Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000

Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217

España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000

France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 422 0606

Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000

Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767

Ísland Slovenská republika
Vistor hf. Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49

Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100

Latvija United Kingdom (Northern Ireland)
Amgen Switzerland AG Rīgas filiāle Amgen Limited
Tel: +371 257 25888 Tel: +44 (0)1223 420305

Other Sources of Information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

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Instructions for Injection of Neulasta Pre-filled Syringe
This section contains information on how to self-administer a Neulasta injection. It is important that you do not attempt to give yourself an injection unless your doctor, nurse, or pharmacist has shown you how to do it. If you have any questions about how to inject, please consult your doctor, nurse, or pharmacist for assistance.

How You or the Person Administering the Injection Should Use Neulasta in Pre-filled Syringe
You must inject the medicine just under the skin. This type of injection is called subcutaneous.

What You Need
To give a subcutaneous injection, you will need:

• one pre-filled syringe of Neulasta; and
• alcohol swabs or similar disinfectants.

What Should I Do Before Giving Myself a Subcutaneous Injection of Neulasta?

1. Remove the medicine from the refrigerator.
2. Do not shake the pre-filled syringe.
3. Do not remove the needle cap from the syringe until you are ready to give the injection.
4. Check the expiry date on the label of the pre-filled syringe (EXP). Do not use it after the last day of the month shown.
5. Check the appearance of Neulasta. It should be a clear, colourless liquid. Do not use it if you see particles in the solution.
6. For a more comfortable injection, allow the pre-filled syringe to sit outside the refrigerator for half an hour to reach room temperature, or hold it gently in your hand for a few minutes. Do not heat Neulasta in any other way (for example, do not heat it in a microwave or in hot water).
7. Wash your hands thoroughly.
8. Find a clean, well-lit, comfortable surface and have everything you need within reach.

How Do I Prepare the Neulasta Injection?
Before giving yourself the Neulasta injection, you must perform the following steps:

1. Hold the syringe and gently remove the needle cap without bending it. Pull horizontally as shown in figures 1 and 2. Do not touch the needle or push the plunger.
2. You may notice a small air bubble in the pre-filled syringe. You do not need to remove the air bubble before injection. Injecting the solution with the air bubble is harmless.
3. The pre-filled syringe is now ready for use.

Where Should I Give Myself the Injection?

The most suitable sites for injection are:

• the upper thigh; and
• the abdomen, except the area around the navel. If someone else is giving you the injection, the back of the upper arms may also be used.

How Do I Give Myself the Injection?

1. Clean the skin with an alcohol swab.
2. Pinch the skin between your thumb and index finger (without squeezing it tightly). Insert the needle into the skin.
3. Push the plunger down slowly and steadily. Push the plunger all the way until all the liquid has been injected.
4. After injecting the liquid, withdraw the needle and release the skin.
5. If you notice a small drop of blood at the injection site, gently wipe it away with a cotton ball or gauze. Do not rub the injection site. If needed, you may cover the injection site with a plaster.
6. Do not reuse any Neulasta remaining in the syringe.

To Remember
Use each syringe only once. If you have any problems, do not hesitate to consult your doctor or nurse for help and advice.

Disposal of Used Syringes

• Do not recap used needles.
• Keep used syringes out of the sight and reach of children.
• Used syringes must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

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Instructions for use:

Guide to parts
Before use After use

Plunger

Used plunger
Syringe label
Used syringe barrel
Finger flange
Syringe label
Used needle
Syringe barrel
Needle safety shield
Safety spring of the
used needle
Grey needle cap
Grey needle cap
removed
with needle inserted
Important
Before using a pre-filled Neulasta syringe with automatic needle protection, read
these important instructions:

• It is important that you do not attempt to administer the injection unless you have received adequate instructions from your doctor or healthcare professional.
• Neulasta is administered as an injection into the tissue just beneath the skin (subcutaneous injection).
• Inform your doctor if you are allergic to latex. The needle cap on the pre-filled syringe contains a latex derivative and may cause severe allergic reactions. Do not remove the grey needle cap from the pre-filled syringe until you are ready for
  the injection.
  Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new
  pre-filled syringe and contact your doctor or healthcare professional.
  Do not attempt to activate the pre-filled syringe before the injection.
  Do not attempt to remove the transparent safety shield from the pre-filled syringe.
  Do not attempt to remove the detachable label from the pre-filled syringe before administering
  the injection.
  Contact your doctor or healthcare professional if you have any questions.

Step 1: Preparation
A Remove the pre-filled syringe from its packaging and gather the necessary materials for the injection: alcohol swabs, a cotton ball or gauze, a bandage, and a sharps disposal container (not included).
For a more comfortable injection, allow the pre-filled syringe to reach room temperature for about 30 minutes before injection. Wash your hands thoroughly with soap and water.
Place the new pre-filled syringe on a clean, well-lit work surface along with the necessary injection materials.
Do not attempt to warm the syringe using a heat source such as hot water or a microwave.
Do not expose the pre-filled syringe to direct sunlight.
Do not shake the pre-filled syringe excessively.

• Keep the pre-filled syringe out of sight and reach of children.

B Open the packaging by tearing off the cover. Grasp the safety shield of the pre-filled syringe to remove the syringe from the packaging.

Grasp here
For safety reasons:
Do not grasp the plunger.
Do not grasp the grey needle cap.

C Check the medicine and the pre-filled syringe.
Medicine

Do not use the pre-filled syringe if:

• The medicine is cloudy or contains particles. It should be a clear, colourless liquid.
• Any parts appear cracked or broken.
• The grey needle cap is missing or not securely attached.
• The expiration date printed on the label has passed the last day of the month indicated.
  In all cases, contact your doctor or healthcare professional.

Step 2: Preparation
A Wash your hands thoroughly. Prepare and clean the injection site.

Upper arm
Abdomen
Upper thigh
You may use:

• The upper thigh.
• The abdomen, except for an area of 5 centimetres around the navel.
• The outer upper arm (only if someone else is administering the injection).
  Clean the injection site with an alcohol swab. Allow the skin to dry. Do not touch the injection site before administering the injection.

Do not inject into areas where the skin is tender, bruised, red, or hardened. Avoid injecting into
areas with scars or stretch marks.

B Carefully remove the grey needle cap by pulling it straight off and away from the body.

C Lift the skin at the injection site to create a stable surface.

It is important to keep the skin lifted during the injection.

Step 3: Injection
A Keep the skin lifted. INSERT the needle into the skin.

Do not touch the cleaned area of skin.

B PUSH the plunger with slow, steady pressure until you feel or hear a "click". Push all the way until the plunger clicks into place.

It is important to push fully until the "click" to ensure the full dose is injected.

C RELEASE the thumb. Then REMOVE the syringe from the skin.

After releasing the plunger, the safety shield on the pre-filled syringe will automatically cover the injection needle securely.
Do not replace the grey needle cap on used pre-filled syringes.

For healthcare professionals only
The trade name of the administered product must be clearly recorded in the patient’s medical record.
Remove and retain the syringe label.

Rotate the plunger to move the label to a position where it can be removed.

Step 4: Completion
A Dispose of the used pre-filled syringe and other materials in a sharps disposal container.

Medicines must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
Keep the syringe and sharps disposal container out of sight and reach of children.
Do not reuse the pre-filled syringe.
Do not recycle pre-filled syringes or dispose of them in household waste.

B Examine the injection site.
If you see blood, press a cotton ball or gauze onto the injection site. Do not rub the injection site. Apply a bandage if needed.