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CLOFARABINE 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CLOFARABINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clofarabine 1mg/ml

concentrate for solution for infusion
clofarabine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
In this leaflet:
1. What Clofarabine is and what it is used for
2. What you need to know before you use
Clofarabine
3. How to use Clofarabine
4. Possible side effects
5. How to store Clofarabine
6. Contents of the pack and other information

1. WHAT CLOFARABINE IS AND WHAT IT
IS USED FOR
This medicine contains the active substance
clofarabine. Clofarabine is one of a family of
medicines called anticancer medicines. It works by
hindering the growth of abnormal white blood cells,
and eventually kills them. It works best against cells
which are multiplying quickly – such as cancer cells.
Clofarabine is used to treat children (≥ 1 year old),
teenagers and young adults up to 21 years old
with acute lymphoblastic leukaemia (ALL) when
previous treatments have not worked or have
stopped working. Acute lymphoblastic leukaemia is
caused by abnormal growth of some types of white
blood cells.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE CLOFARABINE
Do not use Clofarabine:
— if you are allergic to clofarabine or any of the
other ingredients of this medicine (listed in
section 6);
— if you are breast-feeding (please read the section
“Pregnancy and breast-feeding” below);
— if you have severe kidney or liver problems.
Tell your doctor if any of these conditions apply
to you. If you are the parent of a child who is being
treated with Clofarabine, tell the doctor if any of
them apply to your child.

if you lose your appetite, have nausea (feeling
sick), vomiting, diarrhoea, dark-colored urine
and light-coloured stools, stomach pain, jaundice
(yellowing of the skin and eyes), or if you feel
generally unwell, these could be symptoms of an
inflammation of the liver (hepatitis), or liver damage
(hepatic failure)
— if you pass little or no urine, or experience
drowsiness, nausea, vomiting, breathlessness, loss
of appetite and / or weakness (these may be signs
of acute kidney failure / kidney failure).
—

If you are the parent of a child who is being
treated with Clofarabine, tell the doctor if any of
the above conditions apply to your child.
During treatment with Clofarabine, your doctor
will carry out regular blood tests and other tests
to monitor your health. Because of the way this
medicine works, it will affect your blood and
other organs.
Talk to your doctor about contraception. Young men
and women must use effective contraception during
and after treatment. See the section ‘Pregnancy
and breast-feeding’ below. Clofarabine may harm
both male and female reproductive organs. Ask your
doctor to explain what can be done to protect you or
allow you to have a family.
Other medicines and Clofarabine
Tell your doctor if you are using or have recently used:
— medicines for heart disease;
— any medicine that changes your blood pressure;
— medicines that affect your liver or kidneys;
— any other medicines including those obtained
without a prescription.
Pregnancy and breast-feeding
Clofarabine should not be used during pregnancy
unless clearly necessary.

Women who are able to get pregnant: you must
use effective contraception during treatment with
clofarabine. Clofarabine may cause harm to unborn
Warnings and precautions
Talk to your doctor before using Clofarabine. Tell your babies when used by pregnant women. If you are
pregnant or you become pregnant during treatment
doctor if any of these apply to you. Clofarabine may
with clofarabine, get medical advice immediately.
not be suitable for you:
if you have suffered a severe reaction after
previously using this medicine;
— if you have kidney disease, or used to have it;
— if you have liver disease, or used to have it;
— if you have heart disease, or used to have it.
—

Tell your doctor or carer immediately if you
experience any of the following as you may need to
stop treatment:
— if you get a fever or high temperature – because
clofarabine reduces the number of blood cells
made in the bone marrow, you may be more likely
to catch infections;
— if you have breathing difficulties, rapid breathing,
or breathlessness;
— if you feel a change in your heart rate;
— if you suffer from dizziness (light-headedness)
or fainting – it may be a symptom of low blood
pressure;
— if you feel sick or have diarrhoea (loose bowels);
— if your urine is darker than usual – it is important
to drink plenty of water to avoid dehydration.
— if you get a rash with blisters or mouth ulcers

Men must also use effective contraception while they
or their partner are treated with clofarabine.
If you are breast-feeding, you must stop breastfeeding before starting the treatment, and must
not breast-feed during your treatment and within
3 months after completion of your treatment.
Driving and using machines
Do not drive or use any tools or machines if you
feel dizzy, light-headed or faint.
Clofarabine contains sodium chloride
Each vial contains 180 mg of salt (sodium chloride).
This is equivalent to 3.08 mmol (or 70.77 mg) of
sodium. You need to allow for this if you are on a
controlled sodium diet.

3. HOW TO USE CLOFARABINE
Your treatment with Clofarabine has been
prescribed by a qualified doctor experienced in
treating leukaemia.

Your doctor will work out the dose that is right for
you depending on your height, weight and how well
you are. Before Clofarabine is given to you, it will
be diluted in a sodium chloride solution (salt and
water). Tell your doctor if you are on a controlled
sodium diet as it could affect how you will be given
your medicine.
Your doctor will give you Clofarabine once every
day for 5 days. It will be given to you as an infusion
through a long thin tube which goes into a vein
(a drip), or into a small medical appliance that is
inserted under the skin (port-a-cath) if you (or your
child) have one implanted. The infusion will be given
over 2 hours. If you (or your child) weigh less than
20 kg, the infusion time may be longer.
Your doctor will monitor your health and may
change your dose depending on your response to
the treatment. It is important to drink plenty of
water to avoid dehydration.
If you use more Clofarabine than you should
If you think you may have been given too much
medicine, tell your doctor straight away.
If you forget to use Clofarabine
Your doctor will tell you when you need to be given
this medicine. If you think that you have missed a
dose, tell your doctor straight away.
If you have any further questions on the use of this
medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common side effects (may affect more than
1 in 10 people)
— anxiety, headache, fever, tiredness
— feeling and being sick, diarrhoea (loose bowels)
— flushing, itching and inflamed skin, inflammation of
mucus (moist) linings such as the mouth and other
areas
— you may have more infections than normal
because Clofarabine can lower the number of
certain types of blood cells in your body
— skin rashes which may be itchy, red, painful or
peeling skin including palms of the hands and
soles of the feet, or small reddish or purple spots
underneath the skin.
Common side effects (may affect up to 1 in 10
people)
— infections of the blood, pneumonia, shingles,
implant infections, infections of the mouth such as
thrush and cold sores
— changes in blood chemistry, changes in white
blood cells
— allergic reactions
— feeling thirsty and producing darker or less urine
than normal, decreased or loss of appetite,
weight loss
— agitation, irritability, or restlessness
— feeling numb or weak in the arms and legs,
numbness of the skin, sleepiness, dizziness,
tremor
— hearing problems
— water collecting around the heart, fast heartbeat
— low blood pressure, lump due to bad bruising
— leaking from tiny blood vessels, rapid breathing,
nosebleeds, breathing difficulties, breathlessness,
cough
— vomiting blood, stomach ache, pain in the bottom
— bleeding inside the head, stomach, intestine or
lungs, mouth or gums, mouth ulcers, inflamed
mouth lining
— yellowing of the skin and eyes (also called
jaundice), or other liver disorders
— bruising, hair loss, changes to skin colour,
increased sweating, dry skin, or other skin
problems
— pain in the chest wall or bones, neck or back pain,
pain in limbs, muscles, or joints
— blood in urine

failure of organs, pain, increased muscle tension,
water retention and swelling in parts of the body,
including the arms and legs, changes in mental
state, feeling hot, cold or abnormal
— clofarabine may affect the levels of certain
substances in the blood. Your doctor will carry out
regular blood tests to check whether your body is
working properly
— liver damage (liver failure)
— little or no urine, drowsiness, nausea, vomiting,
breathlessness, loss of appetite and /or weakness
(possible signs of acute kidney failure or kidney
failure).
—

Uncommon side effects (may affect up to 1 in
100 people)
— inflammation of the liver (hepatitis).
Reporting of side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed in
this leaflet. You can also report side effects directly
via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE CLOFARABINE
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the vial label and box after ‘EXP’. The
first two digits indicate the month and the last four
digits indicate the year.
Do not freeze.
Once prepared and diluted, Clofarabine should be
used straight away or within 24 hours if stored in a
refrigerator (at 2°C to 8°C).
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Clofarabine contains
The active substance is clofarabine. Each ml
contains 1 mg of clofarabine. Each 20 ml vial
contains 20 mg of clofarabine.
The other ingredients are sodium chloride and
water for injections.
What Clofarabine looks like and contents of
the pack
Clofarabine is a concentrate for solution for infusion.
It is a clear, almost colourless solution that is
prepared and diluted before it is used. It is supplied
in 20 ml glass vials. The vials contain 20 mg of
clofarabine and are packaged in a box. Each box
contains 1, 3, 4, 10 or 20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Synthon BV,
Microweg 22, 6545 CM Nijmegen,
The Netherlands.
Manufacturer:
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat, Spain.
Distributed by:
Consilient Health (UK) Ltd,
No. 1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in 03/2017

P0605

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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