Neupopeg
pegfilgrastim
pegfilgrastim
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor 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 or pharmacist.
What Neupopeg is and what it is used for
Before you use Neupopeg
How to use Neupopeg
Possible side effects
How to store Neupopeg
Further information
Medicinal product no longer authorised
Neupopeg is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Your doctor has given you Neupopeg to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neupopeg.
Please tell your doctor:
if you experience a cough, fever and difficulty breathing;
if you have sickle cell anaemia;
if you get left upper abdominal pain or pain at the tip of your shoulder.
if you have an allergy to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ask your doctor or pharmacist for advice before taking any medicine. Neupopeg 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 become pregnant.
You must stop breast feeding if you use Neupopeg.
The effect of Neupopeg on the ability to drive or use machines is not known.
Medicinal product no longer authorised
Neupopeg contains sorbitol (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neupopeg. Neupopeg is essentially sodium-free.
Neupopeg is for use in adults aged 18 and over.
Always take Neupopeg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Do not shake Neupopeg vigorously as this may affect its activity
Your doctor may decide that it would be more convenient for you to inject Neupopeg yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.
For further instructions on how to inject yourself with Neupopeg, please read the section at the end of this leaflet.
If you use more Neupopeg than you should contact your doctor, nurse or pharmacist.
If you have forgotten a dose of Neupopeg, you should contact your doctor to discuss when you should inject the next dose.
Like all medicines, Neupopeg can cause side effects, although not everybody gets them.
A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain. Your doctor will tell you what you can take to ease the bone pain.
Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back. An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.
Allergic-type reactions to Neupopeg, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients)) of spleen rupture have been reported after the use of Neupopeg. Some cases of splenic rupture were fatal.
It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Medicinal product no longer authorised
Rare (likely to occur in fewer than 1 in 1000 patients)cases of breathing problems have been reported after taking G-CSFs. If you have a cough, fever and difficulty breathing please tell your doctor.
Some changes may occur in your blood, but these will be detected by routine blood tests. Your platelet count may become low which might result in bruising. Your white blood cell count may become high for a short period of time.
Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred very rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.
Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neupopeg.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Neupopeg after the expiry date which is stated on the box and on the syringe label (EXP). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
You may take Neupopeg out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
Do not freeze. Neupopeg may be used if it is accidentally frozen for a single period of less than 24 hours.
Keep the container in the outer carton in order to protect from light.
Do not use Neupopeg if you notice it is cloudy or there are particles in it.
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.
Neupopeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Medicinal product no longer authorised
Neupopeg is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Each pack contains 1 pre-filled syringe. The syringes are provided either with or without a blister wrapping. It is a clear, colourless liquid.
4817 ZK Breda The Netherlands
Dompé Biotec S.p.A. Via San Martino 12
I-20122 Milan Italy
If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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This section contains information on how to give yourself an injection of Neupopeg. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist. If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.
To give yourself a subcutaneous injection you will need:
a pre-filled syringe of Neupopeg; and
alcohol wipes or similar.
Remove from the refrigerator.
Do not shake the pre-filled syringe.
Medicinal product no longer authorised
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.
Check the appearance of Neupopeg. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Neupopeg in any other way (for example, do not warm it in a microwave or in hot water).
Wash your hands thoroughly.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Before you inject Neupopeg you must do the following:
Hold the syringe barrel and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.
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.
You can now use the pre-filled syringe.
The most suitable places to inject yourself are:
the top of your thighs; and
the abdomen, except for the area around the navel.
If someone else is injecting you, they can also use the back of your arms.
Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Put the needle fully into the skin as shown by your nurse or doctor.
Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
Inject the liquid slowly and evenly, always keeping your skin pinched.
After injecting the liquid, remove the needle and let go of your skin.
If you notice a spot of blood at the injection site dab away with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a bandage.
Medicinal product no longer authorised
Only use each syringe for one injection. Do not use any Neupopeg that is left in the syringe.
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Do not put the cover back on used needles.
Keep used syringes out of the reach and sight of children.
The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.