NEUPOGEN 30 MU (0.3MG/ML) SOLUTION FOR INJECTION

Active substance: FILGRASTIM

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Package leaflet: Information for the user

EN

Neupogen 30 MU (0.3 mg/ml)
solution for injection
filgrastim
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.

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

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

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EN
MCK2351

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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.

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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.
• 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 0.3 mg/ml, 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.

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.
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.
How long will I have to take Neupogen?
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.
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.
If you use more Neupogen than you should
If you think you have had more than you should, contact your doctor as soon as possible.
If you forget to use Neupogen
If you have missed an injection, contact your doctor as soon as possible.
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)

This medicine is marketed in the European Economic Area under the name Neupogen, except in
Cyprus, Greece and Italy where it is called Granulokine.

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

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.

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)
• 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)
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 (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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 vial 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 in a 1 ml vial (0.3 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 vial.
Neupogen is available in packs of one or five vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

This leaflet was last revised in September 2014.

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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