Filgrastim (rbe)
Consumer Medicine Information
What is in this booklet
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.
1.
What NEUPOGEN is used for
How it works
2.
Before you use NEUPOGEN
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
4.
Things to do before you inject
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)
5.
While you are using NEUPOGEN
Things you must do
Things you must not do
Storage
Disposal
What it looks like
Ingredients
Supplier
What NEUPOGEN is used for
Your doctor may have prescribed NEUPOGEN because:
(1)
You are receiving chemotherapy for cancer
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.
(2)
You are receiving a bone marrow or stem cell transplant
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.
(3)
You are donating stem cells for another person
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.
(4)
You are suffering from severe chronic neutropenia
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.
(5)
You are receiving medicines for HIV infection
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.
How it works
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.
Before you use NEUPOGEN
When you must not use Neupogen
Do not have NEUPOGEN if you have had an allergy to:
NEUPOGEN or any of the ingredients listed at the back of this booklet
medicine or any other products that are produced by DNA technology using the bacteria E. coli.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
skin rash, itching or hives.
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.
Before you start to use NEUPOGEN
Tell your doctor if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor if you are pregnant or intend to become pregnant or are breastfeeding.
Tell your doctor if you:
have a medical condition affecting the bone marrow or blood
have a family history of a genetic disorder
suffer from sickle cell disease
have problems with your kidneys, liver, heart or other organs
have had previous treatment for cancer
have any infections, cancers or tumours.
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.
Taking other medicines
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.
How to use NEUPOGEN
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.
How much to inject
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.
Where to inject
The best injection sites are
your abdomen, except for the area around the navel (belly button) or
the front or side of your thighs.
Change the injection site each time you inject to avoid soreness at any one site.
When to inject
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.
How long to use it
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.
Things to do before you inject
Make sure that you have all the materials you need for your injection:
a new NEUPOGEN syringe or vial
a syringe if using a NEUPOGEN vial
an alcohol swab
a puncture-resistant sharps container.
Follow these instructions exactly to help avoid contamination and possible infection.
If you are unsure, check with your doctor, nurse or pharmacist.
1.
Find a clean, flat working surface, such as a table, where you can inject undisturbed.
2.
Remove the syringe or vial from the refrigerator. For a more comfortable injection, leave at room temperature for approximately
30 minutes. Do not warm NEUPOGEN in any other way (e.g. do not warm it in the microwave or in hot water).
3.
Check that the syringe or vial has NOT been used before.
4.
Do not shake the syringe or vial. If the NEUPOGEN solution appears frothy or bubbly, allow the syringe or vial to sit undisturbed
for a few minutes to reduce the froth or bubbles before measuring your dose.
5.
Do not remove the needle cover until you are ready to inject.
6.
Check the expiry date on the label. Do not use if the date has passed the last day of the month shown.
7.
Check the appearance of the solution. The solution should be clear and colourless. If it is cloudy, coloured or if there
are clumps or flakes, you must not use it.
8.
Wash and dry your hands thoroughly.
How to prepare your injection - NEUPOGEN Ready to Use Syringe
1.
Hold the syringe vertically with the needle pointing up - this helps reduce the amount of medicine that may leak out of the
needle. Carefully remove the needle cover, taking care not to touch the exposed needle.
2.
Check the dose (in mL) that your doctor has prescribed and locate the correct volume mark on the syringe barrel. Carefully
push the plunger until the grey upper edge of the plunger reaches the correct volume mark. This will push the air and any
excess liquid out of the syringe.
3.
Double-check that you have the correct dose.
How to prepare your injection - NEUPOGEN in a Vial
1.
Check that the syringe you are using is marked every tenth of a mL/cc (i.e. 0.1, 0.2, etc. mL/cc) so that you can accurately
inject the prescribed dose. Use disposable syringes and needles and use them once only.
2.
Flip the protective cap off the vial. Do NOT remove the rubber stopper.
3.
Wipe the top of the rubber stopper with an alcohol swab.
4.
With the needle cover on, carefully pull back on the plunger. This will draw air into the syringe. The amount of air should
be the same as your NEUPOGEN dose.
5.
Carefully remove the needle cover, taking care not to touch the exposed needle.
6.
Gently push the needle through the rubber top of the NEUPOGEN vial.
7.
Carefully push the plunger down. The air injected into the vial will allow NEUPOGEN to be easily withdrawn from the vial
into the syringe.
8.
Turn the vial and syringe upside down. Make sure the tip of the needle is IN the solution. Slowly pull back on the plunger
to draw the correct dose of NEUPOGEN into the syringe.
9.
Check the syringe for air bubbles. The air is harmless, but a large air bubble will reduce the NEUPOGEN dose. To remove
the air bubbles, gently push the solution back into the vial and measure the correct dose of NEUPOGEN.
10.
Check that the correct dose of NEUPOGEN has been drawn into the syringe. Remove the needle from the vial.
How to inject
1.
Clean the site where the injection is to be made with an alcohol swab, moving the alcohol swab in an expanding circle and
allow the site to dry.
2.
Pinch a large area of skin between your thumb and forefinger, to create a firm injection site.
3.
Pick up the syringe and hold it as you would a pencil.
4.
Insert the needle directly into the skin (at an angle of between 45 degrees and 90 degrees or as advised by your doctor, nurse
or pharmacist).
5.
After the needle is in, pull back the plunger very slightly. If blood comes into the syringe, the needle has entered a blood
vessel. Remove the needle. Select another site, clean the new site with an alcohol swab and reinsert the needle. Again,
pull back the plunger very slightly to check for blood. If blood does not appear in the syringe, inject the NEUPOGEN by gently
pushing the plunger all the way in.
6.
Withdraw the needle and using the alcohol swab apply pressure for several minutes to the injection site.
7.
Do not put the needle cover back on the used syringe. You cannot reuse the syringe.
Discard the used syringe into an approved, puncture-resistant, sharps container. If you are using NEUPOGEN vials, dispose
of the used vial in the rubbish.
Do not change the dose or the way you inject NEUPOGEN without consulting your doctor. Always follow your doctor's instructions.
If you forget your injection
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 too much (Overdose)
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.
While you are using NEUPOGEN
Things you must do
Be alert for any signs or symptoms of infection.
There are many ways an infection may show itself.
You should watch for:
fever (a temperature of 38.2 degrees C or greater, or as your doctor suggests)
chills
rash
sore throat
diarrhoea
ear ache
difficult or painful breathing, coughing or wheezing.
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.
Things you must not do
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.
Side effects
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:
rash over a large area of the body
shortness of breath
wheezing
faintness, rapid pulse or sweating.
Severe allergic reactions to NEUPOGEN are very rare.
Tell you doctor immediately if you notice any of the following:
pain in the upper left side of the abdomen
left shoulder pain
dizziness.
fever and painful skin lesions that appear mainly on your face, neck, back and arms.
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:
temporary bone pain, such as in the lower back or in the long bones of the arms or legs.
This pain is usually relieved with non-prescription painkillers, like paracetamol. If you continue to have bone pain even
after having taken this form of pain relief, you should speak to your doctor, as you may need a prescription medication.
abdominal discomfort
bleeding or bruising more than usual, severe nose bleeds, reddish or purplish blotches under the skin
blood in the urine
cough, breathlessness
diarrhoea
hair loss
headache
painful and swollen joints
worsening of existing arthritis
muscle pain
redness, swelling or itching at the site of injection
skin disorders - worsening of existing symptoms
skin rash or red, itchy spots
sore mouth, mouth ulcers
tiredness, looking pale
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.
After using NEUPOGEN
Storage
Keep NEUPOGEN in a refrigerator at a temperature of 2 degrees C to 8 degrees 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.
Disposal
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.
Product description
What it looks like
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:
300 micrograms of filgrastim in a volume of 0.5 mL, in a syringe;
480 micrograms of filgrastim in a volume of 0.5 mL, in a syringe;
300 micrograms of filgrastim in a volume of 1 mL, in a vial; and
480 micrograms of filgrastim in a volume of 1.6 mL, in a vial.
Ingredients
The active ingredient in NEUPOGEN is filgrastim. Other ingredients are:
sodium acetate
sorbitol
polysorbate 80.
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.
Supplier
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 microgram/0.5 mL syringe - AUST R 53580
NEUPOGEN 480 microgram/0.5 mL syringe - AUST R 53581
NEUPOGEN 300 microgram/1 mL vial - AUST R 53579
NEUPOGEN 480 microgram/1.6 mL vial - AUST R 53577
This booklet was prepared on 28 November 2008.
® Registered trademark.