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.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Neupogen is and what it is used for
2. Before you use Neupogen
3. How to use Neupogen
4. Possible side effects
5. How to store Neupogen
6. Further information
7. Instructions for injecting Neupogen
What Neupogen Is And What It Is Used For
Neupogen is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs 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.
Before You Use Neupogen
Do not use Neupogen
- if you are allergic (hypersensitive) to filgrastim or any of the other ingredients of Neupogen.
- if you have Kostman’s Syndrome (severe condition acquired at birth), your doctor will discuss with you whether or not you should take Neupogen.
Take special care with Neupogen
Please tell your doctor before starting treatment:
- if you have sickle cell anaemia, as Neupogen may cause sickle cell crisis;
- if you have an allergy to natural rubber (latex). The needle cover on the syringe is made from a type of natural rubber and may cause severe allergic reactions;
- if you have osteoporosis (bone disease).
If you are a stem cell donor, you must be aged between 16 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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as they may affect the way Neupogen works.
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.
Important information about some of the ingredients of Neupogen
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.
How To Use Neupogen
Always use Neupogen exactly as your doctor has told you. You should 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.
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.
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.
Neupogen and 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 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
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.
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);
- if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Adult Respiratory Distress Syndrome (ARDS);
- if you get left upper belly (abdominal) pain or pain at the tip of your shoulder, as there may be a problem with your spleen.
Like all medicines, Neupogen 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
- nausea and vomiting
- pain in your bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics)
- changes in blood chemistry
in normal stem cell donors
- headache
- increase in white blood cells (leukocytosis), decrease of platelets which reduces the bloods ability to clot (thrombocytopenia)
- pain in your bones (musculoskeletal pain), which can be treated with standard pain relief tablets
in severe chronic neutropenia patients
- low red blood cell count (anaemia), enlargement of the spleen (splenomegaly)
- changes in blood chemistry
- pain in your bones (musculoskeletal pain)
- nose bleeds (epistaxis)
in HIV patients
- pain in your bones (musculoskeletal)
Common side effects (seen in more than 1 in 100 people taking Neupogen):
in cancer patients
- tiredness (fatigue), generalised weakness
- headache
- constipation, anorexia, diarrhoea, soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucositis)
- chest pain, pain in your bones (musculoskeletal pain)
- cough, sore throat
- unusual hair loss or thinning (alopecia), skin rash
in normal stem cell donors
- changes in blood chemistry
in severe chronic neutropenia patients
- headache
- diarrhoea
- decrease of platelets which reduces the bloods ability to clot (thrombocytopenia)
- enlargement of the liver (hepatomegaly)
- disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
- unusual hair loss or thinning (alopecia), injection site pain, rash
in HIV patients
- enlargement of the spleen (splenomegaly)
Uncommon side effects (seen in more than 1 in 1000 people taking Neupogen):
in cancer patients
- unspecified pain
in normal stem cell donors
- changes in blood chemistry
- enlargement of the spleen (splenomegaly)
in severe chronic neutropenia patients
- enlargement of the spleen (splenomegaly)
- blood in the urine (haematuria)
- excess protein in the urine (proteinuria)
Rare side effects (seen in more than 1 in 10,000 people taking Neupogen):
in cancer patients
- problems with your blood vessels (vascular disorders)
Very rare side effects (seen in less than 1 in 10,000 people taking Neupogen):
in cancer patients
- pain when passing urine (dysuria)
Frequency unknown
in cancer patients
- 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 (Sweet’s syndrome)
- worsening of rheumatoid arthritis
- a cough, fever and difficulty breathing (dyspnoea)
- problems with your lungs (pulmonary) including serious lung infection (interstitial pneumonia), swelling and/or fluid in the lungs (pulmonary oedema)
- pain and swelling of the joints, similar to gout (pseudogout)
in normal stem cell donors
- cough, fever and difficulty breathing or coughing up blood.
Some changes may occur in your blood, but these will be detected by routine blood tests.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
How To Store Neupogen
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C).
Accidental freezing will not harm Neupogen.
Do not use Neupogen 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 Neupogen if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further 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
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 approved in July 2010.
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.
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 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.
7. Wash your hands thoroughly.
8. 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.
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
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.
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