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NEUPOGEN SINGLEJECT 30MU(0.6MG/ML)SOLUTION FOR INJECTION

Active substance(s): FILGRASTIM

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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.
• 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.
7.

Neupogen® Singleject®

EN

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

MCK5761

MCK5761

Neupogen contains sorbitol
This medicine contains 50 mg sorbitol in each ml.
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance
(HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with
HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or
if your child can no longer take sweet foods or drinks because they feel sick, vomit or get
unpleasant effects such as bloating, stomach cramps or diarrhoea.

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.

1. What Neupogen is and what it is used for

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.

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.

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.
How long will I have to take Neupogen?

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.

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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 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.

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
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

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).

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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Neupogen.

4. Possible side effects

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 may be made from a
type of natural rubber and may cause allergic reactions.
• osteoporosis (bone disease).

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).
• if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign
of Acute Respiratory Distress Syndrome (ARDS).
• if you experience kidney injury (glomerulonephritis). Kidney injury has been seen in
patients who received Neupogen. Call your doctor right away if you experience puffiness
in your face or ankles, blood in your urine or brown-coloured urine or you notice you
urinate less than usual.
• 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 a condition called “Capillary Leak Syndrome” which causes
blood to leak from the small blood vessels into your body and needs urgent medical
attention.
• if you have a combination of any of the following symptoms:
- fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation,
shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
These could be symptoms of a condition called “sepsis” (also called "blood poisoning"),
a severe infection with whole-body inflammatory response which can be life threatening
and needs urgent medical attention.
• 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).

Please tell your doctor immediately during treatment with Neupogen, if you:
• have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
breathing as these could be signs of a severe allergic reaction (hypersensitivity).
• experience puffiness in your face or ankles, blood in your urine or brown-coloured urine
or you notice you urinate less than usual (glomerulonephritis).
• 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).
Loss of response to filgrastim
If you experience a loss of response or failure to maintain a response with filgrastim treatment, your
doctor will investigate the reasons why including whether you have developed antibodies which
neutralise filgrastim’s activity.
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

A common 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of
platelets may be seen this reduces the ability of your blood to clot (thrombocytopenia), these
will be monitored by your doctor.

Pregnancy and breast-feeding

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Neupogen has not been tested in pregnant or breast-feeding women.

Very common side effects (may affect more than 1 in 10 people):
• decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
• low red blood cell count (anaemia)
• headache
• diarrhoea
• vomiting
• nausea
• unusual hair loss or thinning (alopecia)
• tiredness (fatigue)
• soreness and swelling of the digestive tract lining which runs from the mouth to the anus
(mucosal inflammation)
• fever (pyrexia)

It is important to tell your doctor if you:
• are pregnant or breast-feeding;
• 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 at the end 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 at the
end of this leaflet.
Driving and using machines
Neupogen may have a minor influence on your ability to drive and use machines. This
medicine may cause dizziness. It is advisable to wait and see how you feel after taking
Neupogen and before driving or operating machinery.

Common side effects (may affect up to 1 in 10 people):
• inflammation of the lung (bronchitis)
• upper respiratory tract infection
• urinary tract infection
• decreased appetite
• trouble sleeping (insomnia)
• dizziness
• decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
• tingling or numbness of the hands or feet (paraesthesia)























low blood pressure (hypotension)
high blood pressure (hypertension)
cough
coughing up blood (haemoptysis)
pain in your mouth and throat (oropharyngeal pain)
nose bleeds (epistaxis)
constipation
oral pain
enlargement of the liver (hepatomegaly)
rash
redness of the skin (erythema)
muscle spasm
pain when passing urine (dysuria)
chest pain
pain
generalised weakness (asthenia)
generally feeling unwell (malaise)
swelling in the hands and feet (oedema peripheral)
increase of certain enzymes in the blood
changes in blood chemistry
transfusion reaction

Uncommon side effects (may affect up to 1 in 100 people):
• increase in white blood cells (leukocytosis)
• allergic reaction (hypersensitivity)
• rejection of transplanted bone marrow (graft versus host disease)
• high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric
acid increased)
• liver damage caused by blocking of the small veins within the liver (veno-occlusive
disease)
• 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)
• bleeding from the lung (pulmonary haemorrhage)
• lack of absorption of oxygen in the lung (hypoxia)
• bumpy skin rash (rash macuo-papular)
• disease which causes bones to become less dense, making them weaker, more brittle
and likely to break (osteoporosis)
• injection site reaction
Rare side effects (may affect up to 1 in 1,000 people):
• severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
• sudden life-threatening allergic reaction (anaphylactic reaction)
• pain and swelling of the joints, similar to gout (pseudogout)
• a change in how your body regulates fluids within your body and may result in puffiness
(fluid volume disturbances)
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with
a fever (Sweets syndrome)
• worsening of rheumatoid arthritis
• unusual change in the urine
• bone density decreased

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.
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 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.

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.

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 or search for MHRA Yellow Card in the Google Play or
Apple App Store
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

ILL0397 v2

Where do I give my injection?

ILL0129 v2

Neupogen contains sodium

Package leaflet: Information for the user

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. Push the plunger with a slow constant pressure, always keeping your skin pinched, until
the syringe is empty.
4. Remove the needle and let go of your skin.
5. 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.
6. 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

Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

• 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.

5. How to store Neupogen
Local representative of the marketing authorisation holder:
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Keep the container in the outer carton in order to protect from light.
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
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 Health Products Regulatory Authority (HPRA) www.hpra.ie.

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.

+ Expand Transcript

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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