Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Mozobil?
Mozobil contains the active ingredient plerixafor. 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.
2. What should I know before I use Mozobil?
Do not use if you have ever had an allergic reaction to plerixafor or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Mozobil and affect how it works.
4. How do I use Mozobil?
Your medicine will be given to you by a doctor or a nurse in a hospital.
The dose you will be given will depend on your weight. 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.
5. What should I know while using Mozobil?
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are using Mozobil.
Keep appointments with your treating physician or clinic.
Have any tests when your treating physician says to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Mozobil
affects you.
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Looking after your medicine
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Your medicine will be stored at the hospital. It should be stored below 25°C.
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6. Are there any side effects?
Very common side effects include diarrhoea, feeling sick, and injection site redness
or irritation. Common side effects include headache, dizziness, feeling tired or
unwell, difficulty sleeping, flatulence, constipation, indigestion, vomiting, stomach
symptoms such as pain, swelling or discomfort, dry mouth, numbness around the mouth,
sweating, generalised redness of the skin, joint pains, pains in the muscles and bones.
Serious side effects include swelling of the face, lips, mouth or throat, which may
cause difficultly in swallowing or breathing, hives, fainting, yellowing of the skin
and eyes (jaundice), and a pain in the upper left abdomen (belly) or at the tip of
your shoulder. If you experience any of these serious side effects, call your doctor
straight away, or go straight to the Emergency Department at your nearest hospital.
Active ingredient:
plerixafor
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Mozobil. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Mozobil.
Where to find information in this leaflet:
1. Why am I using Mozobil?
Mozobil contains the active ingredient plerixafor. Mozobil is in a class of medicines called haematopoietic stem cell mobilisers.
Mozobil 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 (arteriesand 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.
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
bloodstream.
2. What should I know before I use Mozobil?
Warnings
Do not use Mozobil if:
you are allergic to plerixafor, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions including
heart problems
kidney problems
high platelet counts
have a history of feeling faint or lightheaded on standing or sitting or have fainted
before upon injections
if you are under 18 years of age. The effects of Mozobil on children and adolescents
have not been studied
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
You should not use Mozobil if you are pregnant.
There are no adequate clinical trials with Mozobil in pregnant women. Tell your doctor
if you are, think you may be or are planning to become pregnant.
It is recommended that you use contraception if you are of child-bearing age during
Mozobil use and for one week after cessation of treatment.
Men treated with Mozobil should use effective contraception during treatment and for
one week after cessation of treatment.
You should not breastfeed if you are being treated with Mozobil.
It is not known if Mozobil is excreted in human milk.
Use in children
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.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with Mozobil and affect how it works.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect Mozobil.
4. How do I use Mozobil?
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.
When to use Mozobil
It usually only needs to be given on two to four consecutive days, but occasionally
has been given for up to 7 consecutive days.
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.
How to use Mozobil
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.
If you are given too much Mozobil
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 immediately.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
medical attention
If too much Mozobil has been injected or it goes into a vein, you may have a serious
allergic reaction.
Your treating physician is trained to work out the correct dose and to contact the Poisons Information Centre
(by calling 13 11 26 in Australia or 0800 764 766 in New Zealand), in case of an overdose.
5. What should I know while using Mozobil?
Things you should do
Keep appointments with your treating doctor 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 doctor 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 doctor may recommend
to perform blood tests to monitor your blood cell count.
Remind any doctor, nurse, dentist or pharmacist you visit that you are using Mozobil.
Driving or using machines
Be careful before you drive or use any machines or tools 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.
Looking after your medicine
Your medicine will be stored at the hospital.
Store below 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.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
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
the environment
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Severe gastrointestinal problems like diarrhoea, vomiting, tummy pain and feeling
sick are rare.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Heart attacks
In studies, patients with risk factors for a heart attack 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
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems in Australia New Zealand at https://pophealth.my.site.com/carmreportnz/s/. By reporting
side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Mozobil contains
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Active ingredient
(main ingredient)
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plerixafor
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Other ingredients
(inactive ingredients)
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sodium chloride
hydrochloric acid
sodium hydroxide (if needed)
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Mozobil 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. (Aust R 158423).
Who distributes Mozobil
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Mozobil® is a registered trademark of Genzyme Corporation, USA.
This leaflet was prepared in May 2025.
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