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Consumer Medicine Information
This booklet answers some common questions about NEUPOGEN®.
Please note that this booklet does not contain everything there is to know about NEUPOGEN®. It does not take the place of talking to your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor has prescribed NEUPOGEN® after considering its likely benefit to you, as well as the potential risks. If you have any concerns about taking this medicine, talk to your doctor, nurse or pharmacist.
Keep this booklet with your medicine. You may need to read this information again.
How it works
When you must not use NEUPOGEN®
Before you start to use NEUPOGEN®
Taking other medicines
How much to inject
Where to inject
When to inject
How long to use it
How to prepare your injection – NEUPOGEN® Ready to Use Syringe
How to prepare your injection – NEUPOGEN® in a Vial
How to inject
If you forget your injection
If you inject too much (Overdose)
Things you must do
Things you must not do
What it looks like
Your doctor may have prescribed NEUPOGEN® because:
Unfortunately, some chemotherapy will reduce the number of neutrophils in your body. Although NEUPOGEN® is not a treatment for cancer, it does help the body to make new neutrophils and this will reduce your chance of developing infections that might require antibiotics and/or hospital stays. It may even increase your chance of receiving your chemotherapy on time and at the right dose.
Blood cells are produced in the bone marrow and arise from special ‘parent’ cells, called stem cells. Some chemotherapy has toxic effects on bone marrow, so your doctor may choose to collect stem cells from your bone marrow or blood – or from a donor’s bone marrow or blood – before you receive your chemotherapy. These collected stem cells are then stored and may be given back to you later, to replace those lost during chemotherapy. This procedure is called a bone marrow or stem cell transplant.
There are normally only a small number of stem cells in your blood; NEUPOGEN® is typically used to increase this number before stem cell collection. You may also receive NEUPOGEN® after a bone marrow or stem cell transplant, to help speed up your recovery.
If you are aged between 16 and 60 years and have volunteered to donate your stem cells for another person, NEUPOGEN® may be used to increase the number of stem cells in your blood before they are collected. Your stem cells can then be given to a patient after he/she has received their chemotherapy.
Severe chronic neutropenia is a disease in which the body does not make enough neutrophils, increasing your risk of fever and/or infection. NEUPOGEN® helps the body to make and maintain the right number of infection-fighting neutrophils, decreasing the risk of infection and the need for antibiotics and/or hospital stays.
Some medicines used to treat HIV (Human Immuno-deficiency Virus) infection, or its complications, can reduce the number of infection-fighting neutrophils in your blood. Your doctor may prescribe NEUPOGEN® if the number of neutrophils falls too low.
By boosting your neutrophil count, NEUPOGEN® will improve your body’s ability to fight infection and may increase your chance of receiving the full dose of some of your HIV medicines. NEUPOGEN® is not a treatment for HIV infection.
NEUPOGEN® – also known as Filgrastim (rbe) - is a copy of a substance normally present in your body, called Granulocyte Colony Stimulating Factor or G-CSF. Using gene technology, NEUPOGEN® is produced in a specific type of bacteria, called E. coli.
G-CSF is produced in the bone marrow and assists in the production of neutrophils, which are a type of white blood cell. Neutrophils help the body fight infections by surrounding and destroying the bacteria that cause them. G-CSF also helps neutrophils to do this work better.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Do not have NEUPOGEN® if you have had an allergy to:
Symptoms of an allergic reaction may include:
Do not use NEUPOGEN® at the same time as your chemotherapy or radiotherapy.
Do not use NEUPOGEN® in the 24 hours before or the 24 hours after you receive your chemotherapy, radiotherapy, bone marrow transplant or stem cell transplant. This is because these types of treatments may stop NEUPOGEN® from increasing the number of infection-fighting neutrophils.
Do not use NEUPOGEN® after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
Do not use NEUPOGEN® if it has been left out of the refrigerator for more than three days.
If you are not sure whether you should use Neupogen®, talk to your doctor or pharmacist.
Tell your doctor if you have allergies to:
Tell your doctor if you are pregnant or intend to become pregnant or are breastfeeding.
Tell your doctor if you:
If you have not told your doctor about any of these things, tell him/her before you use any NEUPOGEN®. Your doctor will decide whether it is safe for you to use NEUPOGEN®.
There is limited experience with the use of NEUPOGEN® in children. Your doctor will discuss the risks and benefits of using it in children.
Tell your doctor if you are taking any other medicines, particularly those that may affect the blood. Also tell him/her about those you buy without a prescription from a pharmacy, supermarket or health food shop.
Follow all directions given to you by your doctor, nurse or pharmacist carefully. They may differ from the information contained in this booklet.
If you do not understand the instructions ask your doctor, nurse or pharmacist for help.
NEUPOGEN® is given by injection, usually into the tissues just below the skin. This is called a subcutaneous injection and it is a simple procedure.
Your doctor, nurse or pharmacist may suggest that you or your carer be taught how to give a subcutaneous injection. This will allow you to have your NEUPOGEN® injection at home.
NEUPOGEN® is sometimes given by injection into a vein. This is called an intravenous injection and is generally given by a doctor or nurse.
Your doctor will tell you the strength of NEUPOGEN® you need and how much you require. How much you need will depend on the reason for your treatment, your body weight and the number of neutrophils in your blood.
For NEUPOGEN® to work properly, you have to use it exactly as your doctor has instructed.
The best injection sites are
The sites are shown in the picture below.
Change the injection site each time you inject to avoid soreness at any one site.
For best results, you should inject NEUPOGEN® at about the same time each day. Your doctor will tell you when to begin your treatment and when to stop.
Patients receiving chemotherapy or who have received a bone marrow or stem cell transplant are only required to use NEUPOGEN® for short periods of time until the number of infection-fighting neutrophils are restored (usually 1 to 3 weeks).
Stem cell donors should receive NEUPOGEN® treatment for 4 to 5 days.
Patients with severe chronic neutropenia are required to use NEUPOGEN® regularly and for a long period of time, to keep the number of infection-fighting neutrophils at a normal level.
Patients with HIV infection need to use NEUPOGEN® daily until their neutrophil numbers are normal. Usually, the dose is then reduced to three injections per week to maintain the neutrophil numbers. Your doctor will tell you how many injections you need each week and on which days they should be given.
Make sure that you have all the materials you need for your injection:
Follow these instructions exactly to help avoid contamination and possible infection.
If you are unsure, check with your doctor, nurse or pharmacist.
Do not change the dose or the way you inject NEUPOGEN® without consulting your doctor. Always follow your doctor’s instructions.
If you miss your scheduled dose, inject it as soon as you can – provided that it is still on the same day.
If you miss a whole day before you remember to inject yourself, do not take a ‘catch-up’ dose or increase your next dose. Advise your doctor, nurse or pharmacist as soon as possible about the missed dose.
If you inject more than the dose recommended by your doctor you should contact your doctor, nurse or pharmacist immediately.
Too much NEUPOGEN® may lead to neutrophil levels that are too high. Research has shown that doses almost 15 times greater than the most common dose do not immediately result in any harmful effects.
Be alert for any signs or symptoms of infection.
There are many ways an infection may show itself.
You should watch for:
If you develop any of these symptoms, go straight to your hospital.
If you are about to be started on any new medicine, tell your doctor, nurse and pharmacist that you are using Neupogen®.
Tell any other doctors who treat you that you are taking this medicine.
If you become pregnant during treatment with NEUPOGEN®, tell your doctor immediately.
Keep all of your doctor’s appointment so that your health can be monitored. Treatment with NEUPOGEN® leads to changes in the numbers of certain blood cells. Your doctor may order blood tests to check the levels of infection-fighting neutrophils and other blood cells.
Blood tests may also be undertaken after you have completed your NEUPOGEN® treatment until your blood cells have returned to normal levels.
Do not use NEUPOGEN® to treat any other complaint unless your doctor tells you to.
Do not give NEUPOGEN® to anyone else, even if they have the same condition as you.
Tell your doctor as soon as possible if you have any problems while using NEUPOGEN®, even if you do not think the problems are connected with the medicine or are not listed in this booklet.
Like other medicines, NEUPOGEN® may have unwanted side effects. Some side effects may be serious and need medical attention. Other side effects are minor and are likely to be temporary. You may also experience side effects caused by other medicines you are taking at the same time as NEUPOGEN®.
Do not be alarmed by this list of possible side effects. You may not experience any of these side effects.
Ask your doctor or pharmacist to answer any questions you may have.
If any of the following happen, stop taking NEUPOGEN® and go straight to hospital, as you may need urgent medical attention:
Severe allergic reactions to NEUPOGEN® are very rare.
Tell you doctor immediately if you notice any of the following:
The above list includes serious side effects that may require medical attention.
Tell your doctor if you notice any of the following and they worry you. Some of these are known side effects of chemotherapy and may not be related to NEUPOGEN®:
Tell your doctor if you notice anything that worries you or that is making you feel unwell, even if it is not on this list. Other side effects not listed above may occur in some people.
Keep NEUPOGEN® in a refrigerator at a temperature of 2°C to 8°C. Exposure to freezing temperatures will not harm NEUPOGEN®, nor will exposure to room temperature for up to three days.
Keep NEUPOGEN® in its carton protected from light.
Keep NEUPOGEN® out of reach of children.
Once you have injected NEUPOGEN®, do not put the needle cover back on the used syringe.
Put the used syringe into an approved, puncture-resistant, sharps container.
Dispose of the full puncture-resistant sharps container as instructed by your doctor, nurse or pharmacist.
Never put used syringes into your normal household rubbish bin.
Dispose of the used vial in the rubbish or as directed by your doctor, nurse or pharmacist.
NEUPOGEN® is a clear, colourless solution and is supplied as ready to use syringes or as ready to use solution in vials.
The syringes and vials are packed in cartons of 10 and are available in the following strengths:
The active ingredient in NEUPOGEN® is filgrastim. Other ingredients are:
The needle cover on the pre-filled syringe contains a derivative of latex.
NEUPOGEN® does not contain lactose, gluten, tartrazine or any other azo dyes.
NEUPOGEN® is supplied in Australia by:
Amgen Australia Pty Ltd
Level 7, 123 Epping Road,
North Ryde NSW 2113
ABN 31 051 057 428
Australian Registration Numbers:
NEUPOGEN® 300 µg/0.5 mL syringe
AUST R 53580
NEUPOGEN® 480 µg/0.5 mL syringe
AUST R 53581
NEUPOGEN® 300 µg/1 mL vial
AUST R 53579
NEUPOGEN® 480 µg/1.6 mL vial
AUST R 53577
This booklet was prepared on 28 November 2008.
® Registered trademark.
Published by MIMS/myDr May 2009