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CLOFARABINE ACTAVIS 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CLOFARABINE / CLOFARABINE

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Package leaflet:
Information for the user

Clofarabine 1 mg/ml
concentrate for solution for
infusion
Read all of this leaflet carefully before
you start using 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.
- If you get any side effects, talk to
your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet

1. What Clofarabine 1 mg/ml
concentrate for solution for infusion
is and what it is used for
2. What you need to know before you
use Clofarabine 1 mg/ml concentrate
for solution for infusion
3. How to use Clofarabine 1 mg/ml
concentrate for solution for infusion
4. Possible side effects
5. How to store Clofarabine 1 mg/ml
concentrate for solution for infusion
6. Contents of the pack and other
information

1

What Clofarabine 1 mg/ml
concentrate for solution
for infusion is and what it
is used for

Clofarabine 1 mg/ml concentrate for
solution for infusion 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
1 mg/ml concentrate for
solution for infusion

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.
Warnings and precautions
Talk to your doctor before using
Clofarabine
Tell your doctor if any of these apply
to you. Clofarabine may not be suitable
for you if you have:
• suffered a severe reaction after
previously using this medicine,
• kidney disease, or used to have it,
• liver disease, or used to have it,
• heart disease, or used to have it.

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.
Children
Safe and effective dosage
recommendation for patients under
1 year old has not been established.
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
babies when used by pregnant women.
If you are pregnant or you become
pregnant during treatment with
clofarabine, get medical advice
immediately.
Men must also use effective
contraception while they or their
partner are treated with clofarabine.
If you are breast-feeding, you must
stop breast-feeding 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 1 mg/ml concentrate for
solution for infusion contains sodium
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
1 mg/ml concentrate for
solution for infusion

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
Tell your doctor or carer immediately if sodium diet as it could affect how you
you experience any of the following as will be given your medicine.
you may need to stop treatment:
Your doctor will give you Clofarabine
• if you get a fever or high
once every day for 5 days. It will be
temperature – because clofarabine
given to you as an infusion through a
reduces the number of blood cells
made in the bone marrow, you may long thin tube which goes into a vein
(a drip), or into a small medical
be more likely to catch infections,
appliance that is inserted under the skin
• if you have breathing difficulties,
(port-a-cath) if you (or your child) have
rapid breathing, or breathlessness,
• if you feel a change in your heart rate, one implanted. The infusion will be
given over 2 hours. If you (or your
• if you suffer from dizziness
child) weigh less than 20 kg, the
(light-headedness) or fainting – it
infusion time may be longer.
may be a symptom of low blood
pressure,
Your doctor will monitor your health
• if you feel sick or have diarrhoea
and may change your dose depending
(loose bowels),
• if your urine is darker than usual – it on your response to the treatment. It is
is important to drink plenty of water important to drink plenty of water to
avoid dehydration.
to avoid dehydration
• if you get a rash with blisters or
If you use more Clofarabine than you
mouth ulcers,
should
• if you lose your appetite, have
If you think you may have been given
nausea (feeling sick), vomiting,
too much medicine, tell your doctor
diarrhea, dark-colored urine and
light-coloured stools, stomach pain, straight away.
jaundice (yellowing of the skin and
eyes), or if you feel generally unwell, If you forget to use Clofarabine
Your doctor will tell you when you
these could be symptoms of an
inflammation of the liver (hepatitis), need to be given this medicine. If you
think that you have missed a dose, tell
or liver damage (hepatic failure),
your doctor straight away.
• if you pass little or no urine, or
experience drowsiness, nausea,

The following information is intended
for healthcare professionals only:
Special precautions for administration
Clofarabine 1 mg/ml concentrate for
solution for infusion must be diluted
prior to administration. It should be
filtered through a sterile 0.2
micrometre syringe filter and then
diluted with sodium chloride 9 mg/ml
(0.9%) intravenous infusion to produce
a total volume according to the
examples given in the table below.
However, the final dilution volume may
vary depending on the patient’s clinical
status and physician discretion. (If the
use of a 0.2 micrometre syringe filter is
not feasible, the concentrate should be
pre-filtered with a 5 micrometre filter,
diluted and then administered through
a 0.22 micrometre in-line filter.)

Suggested dilution schedule based on
the recommended dosage of
52 mg/m2/day clofarabine
Body
surface
area (m2)

Concentrate
(ml)*

Total
diluted
volume

≤ 1.44

≤ 74.9

100 ml

1.45 to 2.40 75.4 to 124.8

150 ml

2.41 to 2.50 125.3 to 130.0

200 ml

*Each ml of concentrate contains 1 mg
of clofarabine. Each 20 ml vial contains
20 mg of clofarabine. Therefore, for
patients with a body surface area
≤ 0.38 m2, the partial contents of a
single vial will be required to produce
the recommended daily dosage of
clofarabine. However, for patients with
a body surface area > 0.38 m2, the
contents of between 1 to 7 vials will be
required to produce the recommended
daily dosage of clofarabine.

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: 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 (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).

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 1 mg/ml
concentrate for solution for infusion
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, hydrochloric acid (for pH
adjustment) and water for injections.
What Clofarabine 1 mg/ml
concentrate for solution for infusion
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. Vials may or may not be
sheathed in a protective sleeve. Each
box contains 1 or 4 vials, but not all
pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
BN22 9AG, United Kingdom
Manufacturer:
S.C. SINDAN-PHARMA S.R.L.,
Romania
This leaflet was last revised in
05/2017
PL 00289/2179
This medicine has been authorised
under “exceptional circumstances”.
This means that because of the rarity of
this disease it has been impossible to get
complete information on this medicine.
The Medicines Healthcare products
Regulatory Agency will review any new
information on this medicine every year
and this leaflet will be updated as
necessary.

Uncommon: 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 at:
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
1 mg/ml concentrate for
solution for infusion

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 expiry
date refers to the last day of that
month.
Do not freeze.
The diluted concentrate is chemically
and physically stable in PVC bags for 3
days at 2°C to 8°C and at room
temperature (up to 25°C). From a
microbiological point of view, it should
be used immediately. If not used
immediately, in-use storage times and
conditions prior to use are the
responsibility of the user and would
normally not be longer than 24 hours
at 2°C to 8°C unless dilution has taken
place under controlled and validated
aseptic conditions.

EAS972
XXXX PL 01

Diluted concentrate
The diluted concentrate is chemically
and physically stable in PVC bags for
3 days at 2°C to 8°C and at room
temperature (up to 25°C). From a
microbiological point of view, it should
be used immediately. If not used
Instructions for handling
immediately, in-use storage times and
Procedures for proper handling of
conditions prior to use are the
antineoplastic agents should be
observed. Cytotoxic medicinal products responsibility of the user and would
normally not be longer than 24 hours
should be handled with caution.
at 2°C to 8°C unless dilution has taken
place under controlled and validated
The use of disposable gloves and
aseptic conditions.
protective garments is recommended
when handling Clofarabine 1 mg/ml
concentrate for solution for infusion. If Disposal
the product comes into contact with
Clofarabine 1 mg/ml concentrate for
eyes, skin or mucous membranes, rinse solution for infusion is for single use
immediately with copious amounts of
only.
water.
Any unused medicinal product or waste
Clofarabine 1 mg/ml concentrate for
material should be disposed of in
solution for infusion should not be
accordance with local requirements.
handled by pregnant women.
The diluted concentrate should be a
clear, colourless solution. It should be
visually inspected for particulate matter
and discolouration prior to
administration.

EAS972
XXXX PL 01

Expand Transcript

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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