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Neulastim®
pegfilgrastim
6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection
This leaflet answers some common questions about NEULASTIM.
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 you taking NEULASTIM
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 NEULASTIM is used for
NEULASTIM solution for injection contains the active ingredient pegfilgrastim.
Using gene technology, pegfilgrastim is produced in a specific type of bacteria, called E. coli.
Pegfilgrastim is a long-acting form of recombinant human Granulocyte Colony Stimulating Factor (GCSF). G-CSF is produced by the body in the bone marrow and assists in the production of
neutrophils, which are a type of white blood cell. Neutrophils defend the body against infection by
destroying bacteria in the blood.
NEULASTIM also helps neutrophils to be more effective.
Some chemotherapy medicines will reduce the number of neutrophils in your body. Although
NEULASTIM is not a treatment for cancer, it is used following chemotherapy to increase the number
of neutrophils. This will reduce your chance of developing infections that might require treatment with
antibiotics and/or hospital stays. NEULASTIM may also help to keep your chemotherapy treatment on
schedule.
NEULASTIM does not cure the underlying illness but it is an important supportive therapy.
Your doctor, however, may have prescribed NEULASTIM for another purpose.
Ask your doctor if you have any questions about why NEULASTIM has been prescribed for
you.
This medicine is available only with a doctor’s prescription.
Before you use NEULASTIM
When you must not use it
Do not use NEULASTIM if:
1. you have previously used pegfilgrastim (NEULASTIM) or filgrastim (NEUPOGEN® or
ZARZIO®) and have had an allergic reaction to pegfilgrastim, filgrastim or any ingredients
listed at the end of this leaflet
2. you have had an allergic reaction to medicines or other products that are produced by
gene technology using the bacteria E. coli
3. you are currently receiving chemotherapy or radiotherapy
4. you have received chemotherapy within the last 24 hours
This is because the chemotherapy medicine may stop NEULASTIM from increasing the number of
infection-fighting neutrophils.
5. the package is torn or shows signs of tampering
6. 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.
7. the medicine has been left out of the refrigerator for more than 3 days.
If you are not sure if you should be using NEULASTIM, talk to your doctor or pharmacist.
Before you start to use it
Tell your doctor if:
1. you have allergies to any other medicines or any other substances such as foods,
preservatives or dyes
2. you are pregnant or plan to become pregnant
Your doctor will discuss the possible risks and benefits of using NEULASTIM during pregnancy.
3. you are breast-feeding or plan to breast-feed
Your doctor will discuss the possible risks and benefits of using NEULASTIM while breast-feeding.
4. you have any other health problems, especially the following:
• a medical condition affecting the bone marrow or blood
• a family history of a genetic disorder called acute myeloid leukemia (AML), with
cytogenetics t(15;17)
• sickle cell disease [an inherited disease in which red blood cells are sickle (curved or
tapered shaped)]
• previous problems with your kidneys, liver, heart or other organs
• previous radiotherapy or chemotherapy treatment for cancer
• any infections, cancers or tumours.
If you have not told your doctor about any of the above, do so before you start to use
NEULASTIM.
Your doctor will decide whether it is safe for you to use NEULASTIM.
Taking other medicines
Tell your doctor if you are taking any other medicines, particularly those which may affect the
blood. Tell your doctor about any medicines or herbal remedies that you have bought from a
pharmacy, supermarket or health food shop.
Some medicines may interfere with NEULASTIM. These medicines include some chemotherapy
medicines, such as fluorouracil, methotrexate and sulfanilamide.
These medicines may be affected by NEULASTIM 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.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while using
NEULASTIM.
Ask your doctor or pharmacist if you are not sure about other medicines you are taking.
How to use NEULASTIM
Follow all directions given to you by your doctor, pharmacist or nurse carefully.
They may differ from the information contained in this leaflet.
NEULASTIM can be administered by a doctor, nurse or by patients themselves.
NEULASTIM is given by injection, usually into the tissues just below the skin. This is called a
subcutaneous injection and it is a simple procedure.
If you do not understand the instructions, ask your doctor, pharmacist or nurse for help.
Instructions for NEULASTIM pre-filled syringe
have received special training from your doctor or nurse. If you are unsure about anything, ask your
doctor or nurse for help.
Things to do before you inject
• a new NEULASTIM ready-to-use pre-filled syringe
• the supplied needle
• an alcohol swab
• a puncture-resistant sharps container
Follow these instructions exactly to help avoid contamination and possible infection.
2. Remove the ready-to-use pre-filled syringe from the refrigerator. For a more comfortable injection,
leave it at room temperature for approximately 30 minutes. Do not warm NEULASTIM in any other
way (e.g. do not warm it in the microwave or in hot water). Do not leave the pre-filled syringe
exposed to direct sunlight.
3. Do not shake the syringe. Shaking will cause NEULASTIM to clump and it will not work properly.
4. Do not remove the needle cover until you are ready to inject.
5. Check the expiry date on the label. Do not use it if the date has passed the last day of the month
shown.
6. 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.
7. 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.
8. Wash and dry your hands thoroughly.
10. Remove the rubber cover from the glass syringe.
11. Connect the needle to the tip of the syringe and fasten it well. You may need to use a bit of force
to do this.
12. Hold the syringe vertically with the needle pointing up – this helps reduce the amount of medicine
that may leak out of the needle. Expel air from the syringe and needle by gently pressing the
plunger upwards.
13. With one hand, squeeze firmly on the base of the needle cover with your thumb and forefinger
(while taking care not to break the glass pre-filled syringe). Turn and pull the needle cover off while
holding the syringe with your other hand, taking care not to touch the exposed needle.
The pre-filled syringe is now ready to use.
The best injection sites are the front or side of the thighs and the abdomen, except for the area around
the navel (belly button). Change the injection site each time you inject to avoid tenderness at any one
site.
How to inject
Always follow the instructions of your doctor, pharmacist or nurse - they may be different from
those below.
14. 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.
15. Pinch a large area of skin between your thumb and forefinger, without squeezing it.
16. Pick up the syringe and hold it like a pencil.
17. 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).
needle has entered a blood vessel. If this happens, remove the needle, choose a new injection
site and repeat steps 13 – 16 again. 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.
19. If blood does not appear in the syringe, inject the NEULASTIM by gently pushing the plunger all
the way in, while keeping your skin pinched.
20. Withdraw the needle and using the alcohol swab, apply pressure for several minutes to the
injection site.
21. Do not put the needle cover back on the used needle. You cannot reuse the NEULASTIM prefilled syringe. Unless your doctor, nurse or pharmacist advises you of another method of disposal,
put the used syringe and needle into an approved, puncture-proof, sharps container
Use NEULASTIM exactly as your doctor has prescribed.
The usual dose is one subcutaneous injection.
When to inject
NEULASTIM should be injected 24 hours after the end of each chemotherapy cycle. Your doctor will
tell you when to begin your treatment and when to stop.
If you miss your scheduled dose, tell your doctor, nurse or pharmacist as soon as possible about your
missed dose.
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 had too much NEULASTIM. 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 NEULASTIM
Things you must do
Tell all doctors, nurses and pharmacists who are treating you that you are using NEULASTIM.
Tell your doctor if you become pregnant while using NEULASTIM.
Be alert for any signs or symptoms of infection.
You should watch out for fever (your body temperature is raised above normal i.e. 37.6°C, or as
advised by your doctor), chills, rash, sore throat, diarrhoea, ear ache, 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.
Blood tests
Keep all of your doctor’s appointments so that your health can be monitored.
Your doctor may arrange for blood tests to check the levels of infection-fighting neutrophils and other
blood cells.
Things you must not do
Do not stop taking NEULASTIM or change the dose without first checking with your doctor.
Do not give NEULASTIM to anyone else, even if they have the same condition as you.
Do not use NEULASTIM to treat other complaints unless your doctor says to.
Do not take other medicines, whether they require a prescription or not, without first telling
your doctor or consulting a pharmacist.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using
NEULASTIM, even if you do not think the problems are connected with the medicine or are not
listed in this leaflet.
Like other medicines, NEULASTIM 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
NEULASTIM.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
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 NEULASTIM:
• bone pain. This pain is usually relieved with non-prescription painkillers, like paracetamol.
If you continue to have bone pain even after taking this form of pain relief, you should
speak to your doctor, as you may need a prescription medicine.
• joint pain, muscle pain, pain in the chest area
• headache
• nausea (feeling sick) and/or vomiting
• skin rash or red, itchy or sore
Tell your doctor immediately if you notice any of the following:
• blood in urine
• fever and painful skin lesions most commonly on your arms, legs and sometimes on your
face and neck
• swelling of the hands, legs, ankles, feet or any other part of the body
• left shoulder pain
• pain in the upper left side of the abdomen
• tiredness, shortness of breath, easy bleeding and frequent infections.
Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you
notice any of the following:
• coughing up blood, bleeding from the lung
• 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
• swelling of your stomach-area (abdomen) and feeling of fullness
• swelling or puffiness
• less frequent urination.
• faintness, rapid pulse, sweating, dizziness.
These may be serious side effects. You may need urgent medical attention.
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.
Ask your doctor or pharmacist if you don’t understand anything in this list.
After using NEULASTIM
Storage
Keep your NEULASTIM in the original container, protected from light, until it is time to use it.
Keep NEULASTIM in the refrigerator where the temperature stays between 2ºC and 8ºC.
Exposure to room temperature of up to three days will not harm NEULASTIM.
Do not freeze.
Do not use NEULASTIM if you think it has been frozen.
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 NEULASTIM where young children cannot reach it.
Disposal
Once you have injected NEULASTIM do not put the needle cover back on the used needle.
Once you have injected NEULASTIM do not put the needle cover back on the used needle.
Discard used syringe and needle into an approved puncture-resistant sharps container and
keep it out of the reach of children.
Dispose of the full puncture-resistant sharps container as instructed by your doctor, nurse or
pharmacist.
Never put the used syringes into your normal household rubbish bin.
If your doctor tells you to stop using NEULASTIM, or it has passed its expiry date, ask your
pharmacist what to do with any NEULASTIM that is left over.
Product Description
Availability
NEULASTIM is supplied as a solution for injection in a single-use pre-filled syringe with an injection
needle.
What it looks like
NEULASTIM is a clear, colourless solution.
Ingredients
Active ingredient - pegfilgrastim
Inactive ingredients
NEULASTIM pre-filled syringes contain the inactive ingredients, sodium acetate, sorbitol, polysorbate
20 and water for injection.
Distributor
NEULASTIM is distributed by:
Amgen (New Zealand) Limited
Level 22, PwC Tower
15 Customs Street West
Auckland 1010
NEW ZEALAND
This leaflet was prepared in November 2020
Neulastim® is a trademark of Amgen Inc.
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