Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Mozobil. It does not contain all
the available information about Mozobil. It does not take the place of talking to
your treating physician or trained health care professional.
All medicines have risks and benefits. Your treating physician has weighed the risks
of you taking Mozobil against the benefits they expect it will have.
If you have any concerns about taking this medicine, ask your doctor or nurse.
Keep this leaflet.
You may need to read it again.
What it is used for
What Mozobil is used for
Plerixafor is a targeted and reversible blocker of a receptor which is present on
many cells in the body, but particularly blood stem cells. Blood stem cells are the
cells which give rise to all the cells in your blood - red cells which carry oxygen
from the lungs to the tissues; white cells which fight infections, and platelets which
stop bleeding. In the case of blood stem cells, this receptor "ties" the blood stem
cells to the bone marrow. If this "tie" is broken, the stem cells will float out into
the blood flowing in your blood vessels (arteries and veins) where they can then be
collected by a process called apheresis. Apheresis involves the insertion of a tube
into a vein. Blood is then sucked out into a machine which collects the cells wanted
(in your case the stem cells) and the unneeded cells are returned back into your veins.
How it works
Mozobil is used to improve the release or "mobilisation" of blood stem cells into
your blood stream; allowing their collection by apheresis, following which they will
be frozen and stored until they are transplanted back to you when you need them to
regenerate your bone marrow and blood.
In studies which have been carried out with Mozobil, it was used with G-CSF (granulocyte-colony
stimulating factor), another medicine which is used to mobilise stem cells into the
There is limited experience with Mozobil in children. Your doctor will discuss the
risks and benefits of using Mozobil in children. If you have any questions about
using Mozobil ask your doctor.
Ask your treating physician if you have any questions about why it has been prescribed
This medicine is only available with a physician's prescription.
It is not addictive.
Before you are given Mozobil
When you must not be given it
Do not take Mozobil if you have an allergy to:
any medicine containing (active ingredient)
any of the ingredients listed at the end of this leaflet.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
kidney problems. Your doctor may adjust the dose
high platelet counts
history of feeling faint or lightheaded on standing or sitting or have fainted before
if you are under 18 years of age. The effects of Mozobil on children and adolescents
have not been studied.
you have any other medical condition.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Like most medicines, Mozobil is not recommended during pregnancy or while breastfeeding.
There is no experience with Mozobil in pregnant women. It is recommended that you
use contraception if you are of child-bearing age.
It is not known if Mozobil is excreted in human milk.
Your doctor can discuss with you the risks and benefits involved.
Taking other medicines
Tell your treating physician or nurse if you are taking any other medicines or health
supplements, including any that you get without a prescription from your pharmacy,
supermarket or health food shop.
Tell your treating physician or nurse if you are using other medicines as these medicines
may be affected by Mozobil or may affect how well it works (different amounts of
these medicines may be needed or different medicines may need to be taken). Your
treating physician or nurse will advise you and decide whether or not to give you
How Mozobil is given
How much to use
The usual dose of Mozobil is 240 microgram/kg body weight by subcutaneous injection
(under your skin). Mozobil should be administered 6 to 11 hours before it is planned
to start collecting blood stem cells by apheresis.
The dose you will be given will depend on your weight. In order to calculate the
dose of Mozobil to be given to you, your weight must be measured. This should be
done within a week of your first Mozobil dose. If you have moderate or severe kidney
problems, your doctor will reduce the dose.
Mozobil will be administrated given to you by a trained health care professional in
a hospital or a clinic.
How to take it
The decision to treat you with Mozobil should be made by a doctor experienced in cancers
or blood diseases. Your medicine will be given to you by a doctor or a nurse in a
hospital. Mobilisation (release of blood stem cells into your blood stream) will be
started by first giving you G-CSF per your doctor's recommendation. If you want to
know more about G-CSF, please ask your doctor.
When it is given
It usually only needs to be given on two to four consecutive days, but occasionally
has been given for up to 7 consecutive days.
How long to use it
The treatment with Mozobil will last until enough stem cells have been collected by
apheresis for you to be able to have a transplant. In a few cases, enough stem cells
may not be collected, and the collection attempt will be stopped.
If you are given too much (overdose)
There have been no reported overdoses of Mozobil. Based on data in a small number
of patients, doses up to 480 microgram/kg body weight have shown to be safe. If you
think you have been given a bigger dose than recommended you should tell your doctor
Do this even if there are no signs of discomfort or poisoning. You may need urgent
If too much Mozobil has been injected or it goes into a vein, you may have a serious
Your treating physician is trained to work out the correct dose and to contact the
Australian Poisons Information Centre (telephone 13 11 26), or the New Zealand National
Poisons Centre (telephone 0800 POISON or 0800 764 766) in case of an overdose.
While you are being given Mozobil
Things you must do
Keep appointments with your treating physician or clinic.
It is important to have the treatment with Mozobil at the appropriate times to make
sure the medicine has the best chance of providing treatment for the condition.
Have any tests when your treating physician says to.
You may experience short-lived abnormal blood laboratory results such as a raised
white blood cell count or low platelet levels. Your treating physician may recommend
to perform blood tests to monitor your blood cell count.
Things to be careful of
Be careful driving or operating machinery until you know how Mozobil affects you.
The effect of Mozobil on your ability to drive a car or operate machinery has not
been studied. Make sure that you know how you react to Mozobil before you drive a
car or operate machinery or do anything else that may be dangerous if you are dizzy,
light-headed, tired or drowsy.
Tell your treating physician or nurse as soon as possible if you do not feel well
after having Mozobil.
Like all medicines, Mozobil can cause side effects, although not everybody gets them.
Your treating physician has weighed the risks of using this medicine against the benefits
they expect it will have for you.
Very common side effects (in more than 1 in 10 patients) include:
injection site redness or irritation.
Ask your treating physician or nurse to answer any questions you may have.
Tell your treating physician or nurse as soon as possible if you notice any of the
following and they worry you:
Common side effects (in fewer than 1 in 10 patients) include:
feeling tired or unwell
stomach symptoms such as pain, swelling or discomfort
numbness around the mouth
sweating generalised redness or the skin
pains in the muscles and bones.
Abnormal dreams and nightmares have also been reported in patients using Mozobil.
If any of the following happen, tell your doctor immediately or go to your nearest
shortly after receiving Mozobil, you experience
swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing
yellowing of the skin and eyes (jaundice)
you have a pain in the upper left abdomen (belly) or at the tip of your shoulder.
Other side effects may include:
Strange dreams and nightmares
In studies, patients with risk factors for a heart attached uncommonly suffered heart
attacks after being given Mozobil and G-CSF. It seems unlikely that Mozobil increases
the risk of having a heart attack because only one of these heart attacks occurred
close to the use of Mozobil, and most of these patients were known to have risk factors
for having a heart attack.
Pins and needles and numbness
Pins and needles and numbness are common in patients being treated for cancers. In
the clinical studies carried out with Mozobil and G-CSF compared to G-CSF alone for
mobilising blood stem cells, there was no difference in the pins and needles and numbness
experienced whether or not the patients were given Mozobil. About one in five patients
suffered from these feelings.
Patients treated with Mozobil rarely get severe gastrointestinal problems like diarrhoea,
vomiting, tummy pain and feeling sick.
Tell your treating physician if you notice any side effects not listed in this leaflet
that is making you feel unwell.
Other side effects not listed above may occur.
Keep out of the reach and sight of children.
Do not store above 25°C.
Once a vial has been opened it must be used immediately or disposed of, because it
does not contain any preservative.
The doctor or nurse will check that the product has not passed its expiry date. Mozobil
should not be used if there are particles in it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect
What it looks like
Mozobil is supplied as a solution for injection in a 2.0mL glass vial. Each vial contains
24mg plerixafor in 1.2mL solution. Each pack contains one vial with clear colourless
or pale yellow liquid.
sodium chloride, hydrochloric acid, sodium hydroxide (if needed), and water for injections
In Australia this product is registered by:
Genzyme Australasia Pty Ltd.
12-24 Talavera Road
North Ryde NSW 2113
Phone: +61 2 9978 3900
Toll Free Number (medical information): 1800 818 806
AUST R 158423
This leaflet was prepared on 26 September 2017.
Mozobil® is a registered trademark of Genzyme Corporation, USA.