The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16216/0038.
Neupogen 30 MU (0.3 mg/ml) solution for injection
Neupogen 30 MU (0.3 mg/ml)
solution for injection
1. What Neupogen is and what it is used for
2. What you need to know before you use Neupogen
3. How to use Neupogen
4. Possible side effects
5. How to store Neupogen
6. Contents of the pack and other information
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:
Talk to your doctor, pharmacist or nurse before using Neupogen.
Please tell your doctor before starting treatment if you have:
Please tell your doctor immediately during treatment with Neupogen, if you:
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 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Neupogen has not been tested in pregnant or breast-feeding women.
Neupogen is not recommended during pregnancy.
It is important to tell your doctor if you:
If you become pregnant during Neupogen treatment, please inform your doctor.
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neupogen.
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.
This medicine contains less than 1 mmol (23 mg) sodium per 0.3 mg/ml vial, that is to say essentially ‘sodium free’.
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.
Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
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 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 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 think you have had more than you should, contact your doctor as soon as possible.
If you have missed an injection, contact your doctor as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please tell your doctor immediately during treatment:
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.
In normal stem cell donors an increase in white blood cells (leucocytosis) 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.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
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.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 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.
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
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the name Neupogen, except in Cyprus, Greece and Italy where it is called Granulokine.
This leaflet was last revised in July 2022.
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk.
Local representative of the marketing authorisation holder:
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.