NEUPOGEN SINGLEJECT 48MU (0.96MG/ML)

Active substance: FILGRASTIM

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Package leaflet: Information for the user

EN

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

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?
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.

• 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.

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.

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.

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

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.

Use in children
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.

1. What Neupogen is and what it is used for

If you use more Neupogen than you should

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.

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.

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.

2. What you need to know before you 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 or breast-feeding women.
It is important to tell your doctor if you:
• are pregnant;
• think you may be pregnant; or
• are planning to have a baby.
If you become pregnant during Neupogen treatment, please inform your doctor. You
may be encouraged to enrol in Amgen’s Pregnancy Surveillance programme. Local
representative contact details are provided in section 6 of this leaflet.
Unless your doctor directs you otherwise, you must stop breast feeding if you use Neupogen.
If you are nursing during Neupogen treatment, you may be encouraged to enrol in
Amgen’s Lactation Surveillance programme. Local representative contact details are
provided in section 6 of this leaflet.
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.

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

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)
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)
in normal stem cell donors
• increase of certain enzymes in the blood
• shortness of breath (dyspnoea)
• 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)
• 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
in severe chronic neutropenia patients
• excess protein in the urine (proteinuria)

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.
Neupogen is injected into the tissue just under the skin. This is known as a
subcutaneous injection.
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.
What do I do before I give myself a subcutaneous injection of Neupogen?
1. Remove the syringe from the refrigerator. Leave the syringe at room temperature for
approximately 30 minutes or hold the pre-filled syringe 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. Do not remove the needle cover until you are ready to inject.
4. 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.
5. 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.
6. Wash your hands thoroughly.
7. 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, 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.

How do I give my injection?

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.

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.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.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.

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.

6. Contents of the pack and other information
What Neupogen contains

The following information is intended for medical or healthcare professionals only:

• 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.

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.

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.

EN

You may change the injection site if you notice the area is red or sore.

Reporting of side effects

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Neupogen®

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Do not 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.

in HIV patients
• enlargement of the spleen (splenomegaly)

7. Instructions for injecting Neupogen

MCK2350

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.

If you forget to use 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

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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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