Neupogen®
Filgrastim
300 mcg in 0.5mL and 480 mcg in 0.5mL (prefilled syringes) and 300 mcg in 1mL
(vials)
solution for injection
What is in this leaflet
This leaflet answers some common questions about NEUPOGEN.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
your taking NEUPOGEN against the benefits expected for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What NEUPOGEN is used for
NEUPOGEN solution for injection contains the active ingredient filgrastim.
Filgrastim is a copy of a substance normally present in your body, called
Granulocyte Colony Stimulating Factor or G-CSF.
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 be more effective. NEUPOGEN does not cure the
underlying illness but it is an important supportive therapy.
Your doctor may have prescribed NEUPOGEN because:
- you are receiving chemotherapy for cancer
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 treatment with antibiotics and/or hospital
stays. NEUPOGEN may also help to keep your chemotherapy treatment on
schedule.
- 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 before you receive your chemotherapy or from a donor's bone
marrow or blood. These collected stem cells are then stored and may be given
to you later to replace those lost during chemotherapy.
- 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.
- 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 the person after he/she has received their chemotherapy.
- you are suffering from severe chronic neutropenia
Severe chronic neutropenia is a condition 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.
- you are receiving medicines for HIV infection
Some medicines used to treat HIV (Human Immunodeficiency 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.
Your doctor, however, may have prescribed NEUPOGEN for another purpose.
Ask your doctor if you have any questions about why NEUPOGEN has been
prescribed for you.
NEUPOGEN is not addictive.
This medicine is available only with a doctor's prescription.
Before you use NEUPOGEN
When you must not use it
Do not use NEUPOGEN if:
- you have had an allergic reaction to NEUPOGEN or any ingredients listed
at the end of this leaflet - you have severe congenital neutropenia (Kostmann's syndrome) - an
inherited lack of neutrophils - the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed
If you take this medicine after the expiry
date has passed, it may not work as well.
If you are not sure if you should be using NEUPOGEN, talk to your
doctor.
Before you start to use it
Tell your doctor if:
- you are pregnant or plan to become pregnant
It is not known whether NEUPOGEN is
harmful to an unborn baby when taken by a pregnant woman. If there is a need
to take NEUPOGEN when you are pregnant your doctor will discuss the risks
and benefits to you and the unborn baby. - you are breast-feeding or plan to breast-feed
It is not known whether NEUPOGEN passes
into breast milk. Breast-feeding is not recommended while you are taking
NEUPOGEN. - you have any other health problems, especially the following:
- some cancers, including myelodysplastic syndrome and some leukaemias
- past problems with your spleen eg: splenomegaly (enlarged spleen)
- you have sickle cell disease (an inherited disease in which red blood
cells are sickle shaped) - you have osteoporosis (thinning of the bones) or other bone diseases
- you have rheumatoid arthritis
- you have previously had radiotherapy or chemotherapy as a treatment
for cancer - you have cancer where the tumour has got in to your bone marrow
- you have an infection in your bone marrow
- you have blood clotting problems and you are going to donate stem
cells for another person - you have HFI (hereditary fructose intolerance) - NEUPOGEN contains
sorbitol which may affect this condition.
- you are taking blood-thinning medicines
- you are under 16 or over 60 years, if you are being prepared to be a
stem cell donor
If you have not told your doctor about any of the above, do so before
you start to use NEUPOGEN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any
that you have bought from a pharmacy, supermarket or health food shop.
Some medicines may interfere with NEUPOGEN. These medicines include
- lithium (Lithicarb®, Priadel®)
- some chemotherapy medicines eg. fluorouracil.
These medicines may be affected by NEUPOGEN or may affect how well it
works. You may need to use different amounts of your medicine, or you may need
to take different medicines.
NEUPOGEN should not be used 24 hours before and 24 hours after having
chemotherapy.
Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking NEUPOGEN.
Ask your doctor or pharmacist if you are not sure about this list of
medicines.
How to have NEUPOGEN
Follow all directions given to you by your doctor, pharmacist or nurse
carefully.
They may differ from the information contained in this leaflet.
NEUPOGEN can be administered by the doctor, nurse or by patients
themselves.
How much to have
Have NEUPOGEN exactly as your doctor has prescribed.
The usual dose varies from 1 to 12 mcg per kg bodyweight depending on your
condition. Your doctor or other health professional will tell you how much
NEUPOGEN to use, how to inject it, how often you should inject it, and for how
many days your NEUPOGEN therapy should be continued.
For NEUPOGEN to work properly, you have to use it exactly as you have been
instructed.
How to have it
Intravenous administration
NEUPOGEN is sometimes given by injection into a vein - this is called an
intravenous injection and is normally given by a doctor or nurse.
Subcutaneous administration
NEUPOGEN is often given by injection into the tissues just below the skin.
This is called a subcutaneous injection and it is a simple procedure. In fact,
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 administer your NEUPOGEN at home.
Where to inject
The best injection sites are the abdomen and the front or side of the
thighs. Change the injection site each time you inject to avoid soreness at
any one site.
When to inject, and for how long
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 up to 14 days, but can be longer).
Stem cell donors would normally receive NEUPOGEN treatment
for 4 to 7 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. The number of injections per week may
then be reduced 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 check before you inject
Before you inject NEUPOGEN always check that:
- the syringe or vial has NOT been used before; and
- the solution is not cloudy or discoloured and contains no clumps or
flakes.
NEUPOGEN may appear frothy or bubbly if the syringe or vial has been shaken
vigorously. This does not affect the way NEUPOGEN works but, before measuring
your dose, you should allow the syringe or vial to sit undisturbed for a few
minutes to reduce the froth or bubbles.
Before proceeding, make sure that you have all the materials you need to
inject your NEUPOGEN; the syringe or vial, alcohol swab and a puncture-proof
container so you can dispose of used needles safely. If you are unsure, check
with your doctor, nurse or pharmacist.
How to prepare your injection
Note: The instructions from your doctor or nurse on how to inject NEUPOGEN
yourself may be different from the method given below. Follow the instructions
of your doctor, pharmacist or nurse carefully.
NEUPOGEN prefilled syringes
Follow these instructions to help avoid contamination and possible
infection.
- Set up the equipment you will need and remove one NEUPOGEN prefilled
syringe from the refrigerator 20 to 30 minutes before the injection is due,
to allow it to reach room temperature. Use each syringe once only and DO NOT
SHAKE. - Wash and dry your hands thoroughly, and find a clean, quiet place where
you can inject undisturbed. - 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 shield, taking care not to touch the exposed needle. - 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. - Double-check that you have the correct dose.
NEUPOGEN vials
Follow these instructions to help avoid contamination and possible
infection.
- Set up the equipment you will need and remove the vial of NEUPOGEN from
the refrigerator 20 to 30 minutes before the injection is due, to allow it
to reach room temperature. Use each NEUPOGEN vial once only and DO NOT SHAKE
THE VIAL. - Check that the syringe you are using is marked every tenth of a mL (i.e.
0.1, 0.2 mL, etc.) so that you can accurately inject the prescribed dose.
Use disposable syringes and needles, and use them once only. - Wash and dry your hands thoroughly, and find a clean, quiet place where
you can inject undisturbed. - Flip the protective cap off the vial. Do NOT remove the rubber stopper.
- Wipe the top of the rubber stopper with an alcohol swab.
- With the needle cap 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. - Carefully remove the needle cap, taking care not to touch the exposed
needle. Gently push the needle through the rubber top of the NEUPOGEN vial. - Carefully push the plunger down. The air injected into the vial will
allow NEUPOGEN to be easily withdrawn from the vial into the syringe. - 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. - 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. - Check that the correct dose of NEUPOGEN has been drawn into the syringe.
Remove the needle from the vial.
How to inject
Always follow the instructions of your doctor, pharmacist or nurse -
they may be different from those below.
- 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. - Spread the skin or pinch a large area of skin.
- Pick up the syringe and hold it as you would a pencil. Insert the needle
directly into the skin (at an angle of between 45 and 90 degrees or as
advised by your doctor, nurse or pharmacist). 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. - Withdraw the needle and using the alcohol swab apply pressure for
several minutes to the injection site. - Do not put the needle cap back on the used syringe. Unless your doctor,
nurse or pharmacist advises you of another method of disposal, put the used
syringe into an approved, puncture-proof, sharps container and, 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 or nurse.
If you forget your injection
Do not take two doses on the same day.
If you remember your NEUPOGEN dose later on in the day you are meant to
take it, then take the dose.
If you remember the next day, skip the missed dose and take your next
dose when you are meant to.
Advise your doctor, nurse or pharmacist as soon as possible about the
missed dose.
If you are not sure what to do, ask your doctor, pharmacist or nurse.
If you have trouble remembering your dose, ask your pharmacist for some
hints.
In case of an overdose
Immediately telephone your doctor, or the National Poisons Information
Centre (telephone 0800 POISON or 0800 764 766), or go to your nearest Accident
and Emergency Centre if you think you or anyone else may have taken too much
NEUPOGEN. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are using NEUPOGEN
Things you must do
Tell all doctors, dentists and pharmacist who are treating you that you
are having NEUPOGEN.
Tell your doctor if you become pregnant while having NEUPOGEN.
Be alert for any signs or symptoms of infection.
There are many ways an infection may show itself. You should watch for
fever (your body temperature is raised above normal), chills, rash, sore
throat, diarrhoea, earache, difficult or painful breathing, coughing or
wheezing.
If you develop any of these symptoms, see your doctor immediately or go
to your nearest Accident and Emergency Centre.
Tell your doctor if, for any reason, you have not taken your medicine
exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your
treatment unnecessarily.
Tell your doctor if you feel that NEUPOGEN is not helping your
condition.
Blood tests:
Be sure to keep all of your appointments with your doctor so that your
progress can be checked.
Treatment with NEUPOGEN leads to changes in the numbers of certain blood
cells. Your doctor will arrange for blood tests before treatment and then
periodically during treatment to monitor these changes. 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 stop taking NEUPOGEN or change the dose without first checking
with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give NEUPOGEN to anyone else even if they have the same condition
as you.
Do not use NEUPOGEN to treat other complaints unless you doctor says to.
Do not take other medicines whether they require a prescription or not
without first telling your doctor or consulting a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how NEUPOGEN
affects you.
However, NEUPOGEN is not expected to affect your ability to drive a car or
operate machinery.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are having NEUPOGEN.
NEUPOGEN helps most people but it may have unwanted side effects in some
people.
All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical treatment if you get some of the
side effects.
You may also experience side effects caused by other medicines you are
taking at the same time as NEUPOGEN. Ask your doctor or pharmacist to answer
any questions you may have.
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:
- bone pain. 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 medicine. - joint pain or worsening of existing arthritis
- muscle pain
- headache
- nausea (feeling sick) and/or vomiting
- diarrhoea or constipation
- loss of appetite
- pain or difficulty in passing urine, blood in the urine
- nose bleeds
- cough
- sore mouth or throat, mouth ulcers
- hair loss
- redness, swelling or itching at the site of injection
- skin rash or red, itchy or sore spots
- tiredness, weakness, looking pale
Tell your doctor immediately or go to your nearest Accident and
Emergency Centre if you notice any of the following:
- 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 - pain in the upper left side of the abdomen
- chest pain
- breathlessness or difficulty breathing
These may be serious side effects. You may need urgent medical attention.
Serious side effects from NEUPOGEN are rare.
This is not a complete list of all possible side effects. Others may occur
in some people and there may be some side effects not yet known.
Tell you doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this
list.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After using NEUPOGEN
Storage
Keep your NEUPOGEN in the original container until it is time to take
it.
Keep NEUPOGEN in the refrigerator where the temperature stays between
2°C and 8°C.
Do not store it, or any other medicines, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep NEUPOGEN where young children cannot reach it, if possible.
Disposal
If your doctor tells you to stop having NEUPOGEN, or it has passed its
expiry date, ask your pharmacist what to do with any NEUPOGEN that is left
over.
Product Description
Availability
NEUPOGEN is supplied as a solution for injection in a prefilled syringe or
vial.
NEUPOGEN 300 mcg in 0.5mL prefilled syringe, in a pack of 1
NEUPOGEN 480 mcg in 0.5mL prefilled syringe, in a pack of 1
NEUPOGEN 300 mcg in 1mL vials come in packs of 5
Each vial or syringe is for single use only.
What it looks like
NEUPOGEN is a sterile, clear, colourless solution.
Ingredients
Active ingredient - filgrastim
NEUPOGEN prefilled syringe containing 300 mcg (30 million units) of
filgrastim in 0.5mL of solution.
NEUPOGEN prefilled syringe containing 480mcg (48 million units) of filgrastim
in 0.5mL of solution.
NEUPOGEN vials containing 300 mcg (30 million units) of filgrastim in 1 mL of
solution.
Inactive ingredients
NEUPOGEN prefilled syringes and vials contain the inactive ingredients;
sodium acetate, sorbitol, polysorbate 80 and water for injection.