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NEUPOGEN SINGLEJECT 48MU (0.96MG/ML)

Active substance: FILGRASTIM

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Package leaflet: Information for the user
Neupogen Singleject 30 MU (0.6 mg/ml)
Neupogen Singleject 48 MU (0.96 mg/ml)
solution for injection in a pre-filled syringe
filgrastim

3. How to use Neupogen
Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not
sure.
How is Neupogen given and how much should I take?

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

Neupogen is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can
also be given as a daily slow injection into the vein (known as an intravenous infusion). The usual dose varies depending
on your illness and weight. Your doctor will tell you how much Neupogen you should take.

Patients having a bone marrow transplant after chemotherapy:
You will normally receive your first dose of Neupogen at least 24 hours after your chemotherapy and at least 24 hours after
receiving your bone marrow transplant.

You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment
at home. However, you should not attempt this unless you have been properly trained first by your health care provider.

What is in this leaflet

How long will I have to take Neupogen?

1.
2.
3.
4.
5.
6.
7.

You will need to take Neupogen until your white blood cell count is normal. Regular blood tests will be taken to monitor the
number of white blood cells in your body. Your doctor will tell you how long you will need to take Neupogen.

Read all of this leaflet carefully before you start using this medicine because it contains important information
for you.

What Neupogen is and what it is used for
What you need to know before you use Neupogen
How to use Neupogen
Possible side effects
How to store Neupogen
Contents of the pack and other information
Instructions for injecting Neupogen













swelling and/or fluid in the lungs (pulmonary oedema)
inflammation of the lungs (interstitial lung disease)
abnormal x-rays of the lungs (lung infiltration)
plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
inflammation of the blood vessels in the skin (cutaneous vasculitis)
worsening of rheumatoid arthritis
unusual change in the urine
pain
liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
bleeding from the lung (pulmonary haemorrhage)
a change in how your body regulates fluids within your body and may result in puffiness

in normal stem cell donors
• rupture of the spleen
• sudden life-threatening allergic reaction (anaphylactic reaction)
• changes in blood chemistry
• bleeding in the lung (pulmonary haemorrhage)
• coughing up blood (haemoptysis)
• abnormal x-rays of the lung (lung infiltration)
• lack of absorption of oxygen in the lung (hypoxia)
• increase of certain enzymes in the blood
• worsening of rheumatoid arthritis

Use in children

in severe chronic neutropenia patients
• excess protein in the urine (proteinuria)

Neupogen is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count
(neutropenia). The dosing in children receiving chemotherapy is the same as for adults.

Reporting of side effects

If you use more Neupogen than you should

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 (see details below). By reporting side effects you can help provide more information on
the safety of this medicine.

Do not increase the dose your doctor has given you. If you think you have injected more than you should, contact your
doctor as soon as possible.
If you forget to use Neupogen

If you have missed an injection, or injected too little, contact your doctor as soon as possible. Do not take a double dose to
make up for any missed doses.

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

Neupogen®

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1. What Neupogen is and what it is used for
Neupogen is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines
called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using
biotechnology for use as a medicine. Neupogen works by encouraging the bone marrow to produce more white blood cells.
A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able
to fight infection. Neupogen stimulates the bone marrow to produce new white cells quickly.
Neupogen can be used:
• to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
• to increase the number of white blood cells after a bone marrow transplant to help prevent infections;
• before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given
back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into
the bone marrow and produce blood cells;
• to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;
• in patients with advanced HIV infection which will help reduce the risk of infections.
2. What you need to know before you use Neupogen
Do not use Neupogen
• if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Neupogen.
Please tell your doctor before starting treatment if you have:
• sickle cell anaemia, as Neupogen may cause sickle cell crisis.
• an allergy to natural rubber (latex). The needle cover on the syringe is made from a type of natural rubber and may
cause allergic reactions.
• osteoporosis (bone disease).

Please tell your doctor immediately during treatment with Neupogen, if you:
• get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be
symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen),
• notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with
a reduced ability of your blood to clot).
Your doctor may want to monitor you closely, see section 4 of the package leaflet.
If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia,
myelodysplastic syndrome (MDS)) You should talk to your doctor about your risks of developing cancers of the blood and
what testing should be done. If you develop or are likely to develop cancers of the blood, you should not use Neupogen,
unless instructed by your doctor.
If you are a stem cell donor, you must be aged between16 and 60 years.
Take special care with other products that stimulate white blood cells
Neupogen is one of a group of products that stimulate the production of white blood cells. Your healthcare professional
should always record the exact product you are using.
Other medicines and Neupogen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Neupogen has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be
pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine. Neupogen could affect
your ability to become pregnant or stay pregnant.
You must not use this medicine if you are breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Neupogen should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel
after taking Neupogen and before driving or operating machinery.

Neupogen contains sodium and sorbitol
Neupogen contains less than 1 mmol (23 mg) sodium per 0.6 mg/ml or 0.96 mg/ml dose, i.e. essentially sodium free.

Neupogen contains sorbitol (E420), if you have been told by your doctor that you have a reaction to some sugars, contact
your doctor before taking this medicinal product.

4. Possible side effects
Please tell your doctor immediately during treatment:
• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the
face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and
shortness of breath (dyspnoea). Hypersensitivity is common in patients with cancer;
• if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress
Syndrome (ARDS). ARDS is uncommon in patients with cancer;
• if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may
be a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).
• if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may
regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
• if you have any of the following or combination of the following side effects:
­ swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal
swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid
fashion.
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak
Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
A very frequent side effect of Neupogen use is pain in your muscles or bones (musculoskeletal pain), which can be helped
by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft
versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant;
signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut,
liver, skin, or your eyes, lungs, vagina and joints. Very commonly seen in normal stem cell donors is increase in white blood
cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be
monitored by your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (seen in more than 1 in 10 people who take Neupogen):
in cancer patients
• changes in blood chemistry
• increase of certain enzymes in the blood
• decreased appetite
• headache
• pain in your mouth and throat (oropharyngeal pain)
• cough
• diarrhoea
• vomiting
• constipation
• nausea
• skin rash
• unusual hair loss or thinning (alopecia)
• pain in your muscles or bones (musculoskeletal pain)
• generalised weakness (asthenia)
• tiredness (fatigue)
• soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)
• shortness of breath (dyspnoea)
in normal stem cell donors
• decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
• increase in white blood cells (leukocytosis)
• headache
• pain in your muscles or bones (musculoskeletal pain)
in severe chronic neutropenia patients
• enlargement of the spleen (splenomegaly)
• low red blood cell count (anaemia)
• changes in blood chemistry
• increase of certain enzymes in the blood
• headache
• nose bleeds (epistaxis)
• diarrhoea
• enlargement of the liver (hepatomegaly)
• skin rash
• pain in your muscles or bones (musculoskeletal pain)
• joint pain (arthralgia)

in HIV patients
• pain in your muscles or bones (musculoskeletal pain)

United Kingdom
Yellow Card Scheme
Tel: Freephone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6767836
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Neupogen
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Accidental freezing will not harm Neupogen.
Do not use this medicine after the expiry date which is stated on the syringe label and carton after EXP. The expiry date
refers to the last day of that month.

Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines
no longer required. These measures will help protect the environment.
6. Contents of the pack and other information

What Neupogen contains

• The active substance is filgrastim 30 million units (0.6 mg/ml) or 48 million units (0.96 mg/ml).
• The other ingredients are sodium acetate, sorbitol (E420), polysorbate 80, water for injections.
What Neupogen looks like and contents of the pack
Neupogen is a clear colourless solution for injection (injection)/concentrate for solution for infusion (sterile concentrate) in a
pre-filled syringe.
Neupogen is available in packs of one or five pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
This medicine is marketed in the European Economic Area under the name Neupogen, except in Cyprus, Greece and Italy
where it is called Granulokine.
This leaflet was last revised in September 2014.
Detailed information on this medicine can be found on the following web sites:
• For UK residents, the Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk.
• For residents of Ireland, the Irish Medicines Board www.imb.ie.

7. Instructions for injecting Neupogen
This section contains information on how to give an injection of Neupogen.
Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.

Common side effects (seen in more than 1 in 100 people taking Neupogen):
in cancer patients
• allergic reaction (drug hypersensitivity)
• low blood pressure (hypotension)
• pain when passing urine (dysuria)
• chest pain
• coughing up blood (haemoptysis)

Neupogen is injected into the tissue just under the skin. This is known as a subcutaneous injection.

in normal stem cell donors
• increase of certain enzymes in the blood
• shortness of breath (dyspnoea)
• enlargement of the spleen (splenomegaly)

What do I do before I give myself a subcutaneous injection of Neupogen?

in severe chronic neutropenia patients
• rupture of the spleen
• decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
• changes in blood chemistry
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• unusual hair loss or thinning (alopecia)
• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
• blood in the urine (haematuria)
• injection site pain
in HIV patients
• enlargement of the spleen (splenomegaly)
Uncommon side effects (seen in more than 1 in 1000 people taking Neupogen):
in cancer patients
• rupture of the spleen
• enlargement of the spleen (splenomegaly)
• severe pain in the bones, chest, gut or joints (sickle cell crisis)
• rejection of transplanted bone marrow (graft versus host disease)
• pain and swelling of the joints, similar to gout (pseudogout)
• severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)
• lungs do not function as they should, causing breathlessness (respiratory failure)

Equipment that you need
To give yourself a subcutaneous injection you will need:
• a new pre-filled syringe of Neupogen; and
• alcohol wipes or similar.

1. Remove one tray containing a syringe from the refrigerator and leave at room temperature for approximately
30 minutes, or hold gently in your hand for a few minutes. This will make the injection more comfortable. Do not
warm Neupogen in any other way (for example, do not warm it in a microwave or in hot water).
2. Do not shake the pre-filled syringe.
3. Place the tray in your hand and peel the paper off the tray.
4. Flip the tray to place the pre-filled syringe onto your palm.
5. Do not remove the needle cover until you are ready to inject.
6. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the
month shown.
7. Check the appearance of Neupogen. It must be a clear and colourless liquid. If there is discolouration, cloudiness or
particles in it, you must not use it.
8. Wash your hands thoroughly.
9. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
How do I prepare my Neupogen injection?
Before you inject Neupogen you must do the following:
1. To avoid bending the needle, securely grasp the pre-filled syringe by the glass barrel.
Gently pull the cover from the needle without twisting as shown in pictures 1 and 2.
2. Do not touch the needle or push the plunger.
3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove
the air bubble before injecting. Injecting the solution with the air bubble is harmless.
4. You can now use the pre-filled syringe.

Where do I give my injection?
The best places to inject are the top of your thighs and the abdomen. If someone else is injecting you,
they can also use the back of your arms.
You may change the injection site if you notice the area is red or sore.

How do I give my injection?
1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
2. Put the needle fully into the skin as shown by your nurse or doctor.
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the
needle out and re-insert it in another place.
4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
5. Remove the needle and let go of your skin.
6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If
needed, you may cover the injection site with a plaster.
7. Only use each syringe for one injection. Do not use any Neupogen that may be left in the syringe.
Remember: if you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposing of used syringes
• Do not put the cover back on used needles, as you may accidentally prick yourself.
• Keep used syringes out of the reach and sight of children.
• Syringes should not be thrown out in the household rubbish. Your pharmacist will know how to dispose of used syringes
or syringes no longer needed.
Local representative of the marketing authorisation holder:
United Kingdom
Amgen Limited
240 Cambridge Science Park
Cambridge
CB4 0WD
United Kingdom
Tel: 01223 420305

Ireland
Amgen Limited
240 Cambridge Science Park
Cambridge
CB4 0WD
United Kingdom
Tel: +44 (0)1223 420305

Neupogen is available on the Royal National Institute of the Blind (RNIB) Medicines
Information Line who can provide this leaflet in a number of physical formats including
large/clear print, Braille and audio CD.
You can also listen to this leaflet when you call the Medicines Information Line.
The RNIB Medicines Information Line is free to use and available 24 hours a day, 7 days a
week. Please call them on 0800 198 5000.
The following information is intended for medical or healthcare professionals only:
When being used as a concentrate for solution for infusion, Neupogen should be diluted in 20 ml of 5% glucose solution.
Please see the Summary of Product Characteristics for full details.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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