Neupogen Singleject 48 MU/0.5 ml solution for injection in a pre-filled syringe

• 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.

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
7. Instructions for injecting Neupogen

• if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).

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.
• 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 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).
• have symptoms of inflammation of aorta (the large blood vessel which transports blood from the heart to the body), this has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience those symptoms.

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.

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:

• 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.

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 pre-filled syringe, 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.

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, 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.

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.

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 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 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

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• 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.

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

Manufacturer

Manufacturer

To give yourself a subcutaneous injection you will need:

• a new pre-filled syringe of Neupogen; and
• alcohol wipes or similar.

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.

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.

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.

• 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.