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Active substance(s): CYTARABINE

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Patient leaflet: Information for the user

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20mg/ml and 100mg/ml
Solution for infusion or injection

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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
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.

• Remission induction is an intensive
treatment to force leukaemia into retreat.
When it works, the balance of cells in your
blood becomes more normal and your
health improves. This relatively healthy
spell is called a remission.
• Maintenance therapy is a milder treatment
to make your remission last as long as
possible. Quite low doses of Cytarabine are
used to keep the leukaemia under control
and stop it flaring up again.
You should consult your doctor if you are
unsure why you have been given Cytarabine,
if you do not feel better or if you feel worse.

What is in this leaflet

2. What you need to know
before you are given

1. What Cytarabine is and what it is used
2. What you need to know before you are
given Cytarabine
3. How Cytarabine is given to you
4. Possible side effects
5. How to store Cytarabine
6. Contents of the pack and other

1. What Cytarabine is and
what it is used for

• Cytarabine is used in adults and children.
• This medicine contains cytarabine, which
is one of a group of the medicines known
as cytotoxics. These medicines are used
in the treatment of acute leukaemias
(cancer of blood where you have too many
white blood cells). Cytarabine interferes
with the growth of cancer cells, which are
eventually destroyed.
• Cytarabine is also used for the induction
and maintenance of remission of

have been reported in children and young
adults given intravenous Cytarabine in
combination with intrathecal methotrexate.

Other medicines and Cytarabine

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Do not use Cytarabine:

• If you are allergic (hypersensitive) to
cytarabine, or any of the other ingredients
of this medicine (listed in section 6).
• If you are already taking medicines that
have caused you to have a low blood
count caused by suppression of your bone
marrow. Your doctor might not give this
medicine if you have a non-malignant
disease, except for immunosuppression.

Warnings and precautions

Tell your doctor if:
• your liver is not working properly. This will
help your doctor decide if Cytarabine is
suitable for you.
• you have had or are due to have
any vaccination including a live or
live-attenuated vaccination.
• you are given Cytarabine in combination
with methotrexate administered through
your spine, because cases of headache,
paralysis, coma and stroke-like symptoms

Tell your doctor or pharmacist if you are:
• given medicines containing 5-Fluorocytosine
(a medicine used to treat fungal infections).
• taking medicines containing digitoxin or
beta-acetyldigoxin which are used to treat
certain heart conditions.
• taking gentamicin (an antibiotic used to
treat bacterial infections).
• given medicines containing
cyclophosphamide, vincristine and
prednisone which are used in cancer
treatment programmes.
• Taking, have recently taken or might
take any other medicines, even those not


If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your
doctor or pharmacist for advice before you are
given this medicine because Cytarabine may
cause birth defects. Avoid becoming pregnant
while you or your partner is being treated with
Cytarabine. If you are sexually active, you are
advised to use effective birth control to prevent
pregnancy during treatment, whether you are
male or female.


You should stop breast-feeding before starting
treatment with Cytarabine because this
medicine may be harmful to infants being

Driving and using machines

If you feel unwell following treatment with
Cytarabine you should avoid driving or using

3. How Cytarabine is given
to you

Cytarabine will be given to you by infusion into
a vein (through a ‘drip’) or by injection under
the direction of specialists in hospital. Your
doctor will decide what dose to give and the
number of days’ treatment you will receive
depending on your condition.
The dose of Cytarabine will be decided by
your doctor based on your condition being
treated for, whether you are in induction or
maintenance therapy and your body surface
area. Your body weight and height will be used
to calculate your body surface area.

Regular Check-ups

During treatment you will need regular checks
including blood tests. Your doctor will tell you
how often this should be done. He/she will be
making regular checks of:
• your blood - to check for low blood cell
counts that may need treatment.
• your liver - using blood tests - to check
that Cytarabine is not affecting the way it
functions in a harmful way.
• your kidneys - using blood tests - to check
that Cytarabine is not affecting the way it
functions in a harmful way.
• Blood uric acid levels - Cytarabine may
increase uric acid levels in the blood. Another
medicine may be given if your uric acid levels
are too high.

If you receive high doses of

High doses can worsen side effects like sores
in the mouth or may decrease the number of
white blood cells and platelets (these help the
blood to clot) in the blood. Should this happen,
you may need antibiotics or blood transfusions.
Mouth ulcers can be treated to make them less
uncomfortable as they heal.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or

4. Possible side effects

Like all cytotoxic medicines, this medicine
causes side effects, although not everybody
gets them.
Tell your doctor or nursing staff who
will be monitoring you during this time
immediately, if you suffer from the following
symptoms after taking this medicine:
• An allergic reaction such as sudden
wheeziness, difficulty in breathing, swelling of
eyelids, face or lips, rash or itching (especially
affecting the whole body).
• You are feeling tired and lethargic.
• You have flu like symptoms e.g. raised
temperature or fever and chills.
• You bruise more easily or bleed more than
usual if you hurt yourself. These are the
symptoms of low numbers of blood
cells. Tell your doctor or nursing staff
immediately if you experience these

Other side effects that may occur are:
If any of these side effects gets serious
please tell your doctor or nursing staff

Very common: may affect more
than 1 in 10 people

• Pneumonia, infection (which can become
serious and lead to organ failure),
• Insufficient production or decrease in
numbers of red blood cells, white blood
cells or platelets.
• Inflammation or appearance of sores in
the mouth, lips, or on the anus (back
passage), feeling sick, being sick,
diarrhoea, abdominal pain
• Liver damage
• Hair loss is common and may be quite
severe. Hair normally re-grows when your
treatment course ends. Skin rash
• Cytarabine syndrome, sometimes the
following side effects can happen together
6 to12 hours after receiving Cytarabine.
Feeling generally unwell with a high
temperature, pain in bone, muscle and
sometimes the chest, blistery rash, sore
eyes. This is called “Cytarabine Syndrome”
and can be treated.
• Feeling hot and feverish
• Abnormal bone marrow results from a
biopsy, or blood results from a smear test

Common: may affect up to 1 in 10
• Ulceration on your skin

Not known: frequency cannot be
estimated from the available data

• You may get an infection, including
infection or inflammation at the site of your
• Loss of appetite
• Headaches or feeling dizzy, feeling of pins
and needles, shaking and fits, drowsiness
• Conjunctivitis
• Pericarditis (inflammation of the covering
of the heart)
• Slower than usual heart rate or heart beat
• Inflammation to your veins (caused by a
blood clot)
• Shortness of breath, sore throat, pain or
difficulty swallowing
• Pancreatitis (pain in the upper abdomen)
often accompanied by feeling sick or
vomiting, inflammation or ulcers in the
gullet, causing heartburn may make you
feel sick,
• Jaundice (seen as yellowing of the skin
and whites of the eye)
• Skin redness (similar to sunburn), pain and
numbness in joints, fingers, toes or face,
swelling of the abdomen, legs, ankles and


feet, a sensation of tingling or burning,
tenderness and tightness of the skin, thick
calluses on the palms and hands, itchy
skin rash, itching or increased freckles
• Difficulty or pain when passing urine.
Blood in your urine and impaired kidney
The following side effects have been reported
with high dose therapy:

Very common: may affect more
than 1 in 10 people

• Paralysis caused by cerebral disorder,
experience problems in walking, speech
problems, involuntary muscle movement
caused by cerebellar disorder, tiredness,
weakness, fainting
• Eye infection, irritation, pain and blurred
vision, visual loss
• Short or stabbing chest pain, build up of
fluid in the lungs

Common: may affect up to 1 in 10
• Peeling of the skin
• Infection and inflammation of the
intestines, most common in babies

Not known: Frequency cannot be
estimated from the available data

• A pus-filled mass inside the liver
• Changes in your personality
• Coma, convulsions, poor balance caused
by damage to nerves
• Fast heart beat, reduced function of the
heart, shortness of breath, dizziness,
swelling of legs, ankles, feet and veins in
the neck (cardiomyopathy), which can be
• Slower than usual heart rate or heart beat
• Blood in vomiting or in stools
(gastrointestinal necrosis or ulcer),
stomach pain or tenderness (peritonitis)

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at: or search for
MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects, you can help
provide more information on the safety of this


5. How to store Cytarabine

Keep out of the sight and reach of
Hospital staff will store your medicine safely.
The unopened vials should be stored in the
original container between 15ºC and 25ºC until
ready for use.
Cytarabine should not be used after the expiry
date which is stated on the vial label and carton
after EXP. The expiry date refers to the last day
of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

Company Contact Address:

For further information on your medicine
contact Medical Information at Pfizer Limited,
Walton Oaks, Tadworth, Surrey,
Tel: 01304 616161.
This leaflet was last revised in 09/2017.
Ref: CC 14_0

6. Contents of the pack and
other information
What Cytarabine contains

The active ingredient is cytarabine.
The other ingredients in Cytarabine 20mg/ml
are hydrochloric acid, sodium hydroxide,
nitrogen, water for injections and sodium
The other ingredients in Cytarabine 100mg/ml
are hydrochloric acid, sodium hydroxide,
nitrogen and water for injections.

What Cytarabine looks like and
contents of the pack

Cytarabine is a solution available in two
strengths: 20mg/ml and 100mg/ml.
Cytarabine containing 20mg/ml is supplied in
plastic vials containing 100mg (5ml) or 500mg
Cytarabine containing 100mg/ml is supplied in
plastic vials 1000mg (10ml) or 2000mg (20ml).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
CT13 9NJ
United Kingdom


Pfizer Service Company BVBA
10 Hoge Wei
1930 Zaventem


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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.