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CYTARABINE 100MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CYTARABINE / CYTARABINE

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Pregnancy, breast-feeding and
fertility
Pregnancy
Avoid becoming pregnant while you
Package leaflet:
or your partner is being treated with
Information for the user
Cytarabine. If you are sexually active,
you are advised to use effective birth
Cytarabine 100 mg/ml
control to prevent pregnancy during
Solution for Injection or treatment, whether you are male or
female. Cytarabine may cause birth
Infusion
defects, so it is important to tell your
Read all of this leaflet carefully
doctor if you think you are pregnant.
before you start using this medicine
Men and women have to use
because it contains important
effective contraception during and
information for you.
up to 6 months after treatment.
• Keep this leaflet. You may need to
Breast-feeding
read it again.
• If you have any further questions, You should stop breast-feeding
ask your doctor, pharmacist or nurse. before starting treatment with
• If you get any side effects, talk to Cytarabine because this medicine
may be harmful to infants being
your doctor, pharmacist or nurse.
breast-fed.
This includes any possible side
effects not listed in this leaflet. See Fertility
section 4.
Cytarabine may lead to suppression
of menstrual cycles and ammenorrhoea
What is in this leaflet
in female patients, and may suppress
sperm production in male patients.
1. What Cytarabine Solution for
Injection or Infusion is and what it Male patients undergoing cytarabine
treatment should use a reliable
is used for
contraceptive method.
2. What you need to know before
you are given Cytarabine Solution Ask your doctor or pharmacist for
for Injection or Infusion
advice before taking any medicine.
3. How to use Cytarabine Solution
Driving and using machines
for Injection or Infusion
Cytarabine does not affect your
4. Possible side effects
ability to drive or use machinery.
5. How to store Cytarabine Solution
However, cancer treatment in
for Injection or Infusion
general can affect the ability of some
6. Contents of the pack and other
patients to drive or operate
information
machines. If you are affected, you
1 What Cytarabine Solution should not drive or use machinery.

for Injection or Infusion
is and what it is used for

3

Cytarabine Solution for Injection or
Infusion is used in adults and
children. The active ingredient is
cytarabine.
Cytarabine is one of a group of
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.
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.

How to use Cytarabine
Solution for Injection or
Infusion

Method and routes of administration
Cytarabine will be given to you
either by infusion into a vein
(through a ‘drip’), by injection into a
vein or by subcutaneous 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 recommended dose is
Your doctor will decide the dose of
Cytarabine, based on your condition,
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.
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
you need to know
2 What
• your liver (again using blood tests)
before you are given
to check that Cytarabine is not
Cytarabine Solution for
affecting the way it functions in a
Injection or Infusion
harmful way
• your kidneys (again using blood
Do not use Cytarabine if:
tests) to check that Cytarabine is
• you are allergic to cytarabine, or
not affecting the way it functions
any of the other ingredients of this
in a harmful way
medicine (listed in section 6)
• the cell count in your blood report • blood uric acid levels, as cytarabine
may increase uric acid levels in the
is very low due to some cause
blood. Another medicine may be
other than cancer, or as decided by
given if your uric acid levels are
your doctor
too high.
• you are feeling increasing
difficulties in body coordination
If you are on dialysis, the doctor may
after radiation treatment with
alter the time of drug administration
another anticancer drug such as
as dialysis may decrease the
methotrexate.
effectiveness of the medicine.
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Warnings and precautions
Talk to your doctor, pharmacist or
nurse before using Cytarabine. Take
special care with Cytarabine:
• if your bone marrow is in low
state, therapy should be initiated
under close medical supervision
• if you have problems with your liver
• Cytarabine strongly reduces blood
cell production in the bone
marrow. This can make you more
prone to infections or bleeding.
The blood cell numbers can
continue to fall for up to a week
after stopping treatment. Your
doctor will test your blood
regularly and examine your bone
marrow if required
• serious and sometimes
life-threatening side effects can
occur in the central nervous
system, the bowels or lungs
• your liver and kidney functions
should be monitored during
cytarabine therapy. If your liver is
not working well before treatment,
cytarabine should be given only
with utmost care
• the levels of uric acid (showing
that the cancer cells are destroyed)
in your blood (hyperuricaemia)
may be high during treatment.
Your doctor will tell you if you
need to take any medicine to
control this
• during treatment with cytarabine
administration of live or attenuated
vaccine can lead to serious or
life-threatening infections. If
required, consult your doctor. Use
of killed or inactivated vaccine may
not have the desired effect due to
suppressed immune system while
on cytarabine
• do not forget to tell your doctor if
you have received radiotherapy.
Other medicines and Cytarabine
Solution for Injection or Infusion
Tell your doctor or pharmacist if you
are using, have recently used or
might use any other medicines. In
particular, tell your doctor if you are
using medicines containing any of
the following:
• 5-Fluorocytosine (a medicine used
to treat fungal infections)
• Digitoxin or beta-acetyldigoxin,
which are used to treat certain
heart conditions
• Gentamicin (an antibiotic used to
treat bacterial infections)
• Cyclophosphamide, vincristine and
prednisone which are used in
cancer treatment programmes.

If you receive high doses of
cytarabine
High doses can worsen side effects
such as 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 nurse.

4

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them. The side
effects of Cytarabine are dependent
on the dose. The digestive tract is
most commonly affected, but also
the blood.
Tell your doctor or nursing staff
immediately if you suffer from the
following symptoms after you are
given 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) (frequency
cannot be estimated from the
available data)
• severe allergic reaction
(anaphylaxis): Skin rash (including
red itchy skin); swelling of the
hands, feet, ankles, face, lips,
mouth or throat (which may cause
difficulty in swallowing or
breathing); bronchospasm
(narrowing of the airways); and
you may feel you are going to
faint (a spontaneous loss of
consciousness caused by
insufficient blood to the brain). It
can be life-threatening (may affect
up to 1 in 100 people)
• clinical signs of pulmonary oedema
/ Acute Respiratory Distress
Syndrome (ARDS): Sudden,
distressing breathing difficulties
and water in the lungs. These are
more likely to develop with high
dose therapy (frequency cannot be
estimated from the available data)
• you are feeling tired and lethargic.
These are symptoms of low
numbers of red blood cells (may
affect up to 1 in 10 people)
• you have flu like symptoms e.g.
raised temperature, fever and

The following information
is intended for healthcare
professionals only:

minutes, with adequate shaking, and
allowed to cool to room temperature.
Once opened, the contents of each
vial must be used immediately.
Method of administration
Discard any unused contents.
By intravenous infusion or injection,
Cytarabine 100 mg/ml Solution for
or subcutaneous injection only.
Injection or Infusion can be diluted
Cytarabine 100 mg/ml Solution for
with 0.9 % sodium chloride solution
Injection or Infusion should not be
for infusion or 5 % glucose solution.
administered by any other route.
Cytotoxic Handling Guidelines
Instruction for Use/Handling
For single use only.
Administration
Cytarabine Solution for Injection or
The undiluted/diluted solution
Infusion should be administered by,
should be clear, colourless to pale
yellow and free from visible particles. or under the direct supervision of a
qualified physician who is
If the solution contains visible particles, experienced in the use of cancer
it should be warmed to 55°C, for 30 chemotherapeutic agents.
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chills. These are symptoms of low
numbers of white blood cells (may
affect up to 1 in 10 people)
• you bruise more easily or bleed
more than usual if you hurt
yourself. These are symptoms of
low numbers of blood platelets
(may affect up to 1 in 10 people)
• severe pain in the chest (may
affect up to 1 in 100 people)
• severe pain in the abdomen
(frequency cannot be estimated
from the available data)
• loss of vision (frequency cannot be
estimated from the available data),
loss of sense of touch, mental
disturbance or loss of ability to
move normally (this medicine may
cause side effects to the brain and
eyes which are usually reversible
but may be very serious).
These are serious side effects. You
may need urgent medical attention.
Other side effects:
Common: may affect up to 1 in 10
people
• abnormal red blood cells
(megaloblastosis)
• loss of appetite (anorexia)
• stomach ache (abdominal pain)
• difficulty in swallowing
• feeling sick (nausea)
• vomiting
• diarrhoea
• inflammation or ulceration of the
mouth or anus
• reversible effects on the skin such
as reddening (erythema),
blistering, rash, hives, blood vessel
inflammation (vasculitis), hair loss
• reversible effects on the liver such
as increased enzyme levels
• reversible effects on the eyes such
as sore eyes with bleeding
(haemorrhagic conjunctivitis) with
vision disturbance, sensitivity to
light (photophobia), watery or
burning eyes and inflammation of
the cornea (keratitis)
• fever
• inflammation of the vein at the site
of injection
• abnormally high blood uric acid
levels (hyperuricaemia)
• impaired kidney function
• inability to pass urine (urinary
retention)
Uncommon: may affect up to 1 in
100 people
• sore throat
• headache
• blood poisoning (sepsis)
• inflammation and ulcers of the
gullet
• severe bowel inflammation
(necrotising colitis)
• bowel cysts
• inflammation of the inner lining of
the stomach (peritonitis)
• ulceration of the skin
• itching
• brown/black spots on the skin
(lentigo)
• yellowish skin and eye balls
(jaundice)
• lung infection (pneumonia)
• breathing difficulty
• damage to peripheral nerves
causing symptoms such as tingling,
weakness or pain in your hands or
feet (peripheral neuropathy)
• muscle and joint pain
• inflammation of the lining that
surrounds the heart (pericarditis)
• chest pain
• burning pain of palms and soles
• bacterial infection of the skin
(cellulitis) at the site of injection
Very rare: may affect up to 1 in
10,000 people
• inflammation of the sweat glands
• irregular heart beat (arrhythmias)
Not known: frequency cannot be
estimated from the available data
• damage to nervous tissue (neural
toxicity) and inflammation of one
or more nerves (neuritis)
• reduced number of immature red
blood cells (reticulocytes)
• dizziness
• inflammation of the pancreas
(pancreatitis)
• sore eyes (conjunctivitis)
• impaired liver function
• liver abscess
• freckling
• skin rash
The following side effects have also
been reported with the use of
Cytarabine but how often they occur
is not known:
• a so-called ‘Cytarabine Syndrome’
may occur 6-12 hours after the
start of treatment. The symptoms
include: Fever, bone and muscle
pain, occasional chest pain, rash,
sore eyes (conjunctivitis), nausea
(feeling sick). Your doctor may
prescribe corticosteroids
(anti-inflammatory medicines) to
prevent or treat these symptoms. If
they are effective, treatment with
cytarabine may be continued
• heart muscle disease
(cardiomyopathy)
• abnormal muscle breakdown
(rhabdomyolysis)
• loss of sperm and menstrual cycle
• paralysis of the legs and lower
body can occur when cytarabine is
given into the space surrounding
the spinal cord. This method of
administration is not
recommended.
Additional reactions observed with
higher dose therapy
Blood disorders
A severe reduction in blood cells
(pancytopenia), which can cause
weakness, bruising and make
infections more likely.
Central nervous system
The following symptoms, which are
usually reversible, may develop in up
to one third of patients after
treatment with high cytarabine
doses:
• personality changes, changed
alertness, difficulty in speaking,
problems of coordination, tremor,
abnormal eye movements
(nystagmus), headache, peripheral
motor and sensory neuropathies
(damage to nerves of the
peripheral nervous system),
confusion, sleepiness, dizziness,
coma, convulsions.

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Skin disorders
A skin rash leading to scaling and
peeling of the skin has been
observed with high-dose therapy.
Digestive tract
Especially in treatment with high
doses of cytarabine more severe
reactions may appear in addition to
the common symptoms. Perforation,
death of tissue (necrosis) and
obstruction of the bowel have been
reported.
Lungs
Acute, distressing breathing
difficulties and water in the lungs
(pulmonary oedema) have been
observed, particularly at high doses.
Liver problems
Liver abscesses, liver enlargement,
blockage of liver veins and
inflammation of the pancreas have
been observed after high-dose therapy.
Others
• effects on the surface of the eye
(corneal toxicity)
• viral, bacterial etc infections
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:
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 Cytarabine
Solution for Injection or
Infusion

Keep this medicine out of the sight
and reach of children.
Unopened container
Do not store above 25ºC.
Do not refrigerate or freeze.
Keep the vial in the outer carton in
order to protect from light.
Solution for infusion
Chemical and physical in-use stability
of the diluted solution has been
demonstrated in 0.9% sodium chloride
solution for infusion between 0.1 mg/ml
and 21.6 mg/ml for up to 28 days at
temperature below 25°C and for up
to 28 days at 2-8° C.
Chemical and physical in-use stability
of the diluted solution has been
demonstrated in 5% glucose solution
between 5.4 mg/ml and 21.6 mg/ml
for up to 10 days at temperature
below 25°C and for up to 28 days at
2-8°C. The diluted solutions do not
require protection from light at 25°C
storage conditions.
From a microbiological point of view,
the product 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 2-8°C, unless
dilution has taken place in controlled
and validated aseptic conditions.
Do not use this medicine after the
expiry date which is stated on the
vial or carton label after EXP. The
expiry date refers to the last day of
that month.
Do not use this medicine if you notice
that the solution is not clear, colourless
to pale yellow and free from particles.
Do not throw away any medicines
via wastewater . Ask your pharmacist
how to dispose of medicines you no
longer use. These measures will help
to protect the environment.

6

Contents of the pack and
other information

What Cytarabine Solution for
Injection or Infusion contains
• The active substance is cytarabine.
One ml solution contains 100 mg
cytarabine.
• Each 1 ml vial contains 100 mg
cytarabine.
• Each 5 ml vial contains 500 mg
cytarabine.
• Each 10 ml vial contains
1000 mg cytarabine.
• Each 20 ml vial contains
2000 mg cytarabine.
• The other ingredients are:
• macrogol 400
• trometamol
• water for injections.
What Cytarabine Solution for
Infusion or Injection looks like and
contents of the pack
Cytarabine Solution for Injection or
Infusion is a clear, colourless to pale
yellow solution for injection or
infusion.
Colourless glass vial with rubber
stopper coated with Fluorotec and an
aluminium metallic cap with
propylene disk.
The vial may or may not be sheathed
in a protective sleeve.
100 mg/1 ml (butyl, 3 ml nominal fill
volume)
500 mg/5 ml (bromobutyl, 5 ml
nominal fill volume)
1000 mg/10 ml (bromobutyl, 10 ml
nominal fill volume)
2000 mg/20 ml (bromobutyl, 20 ml
nominal fill volume)
Pack sizes
Each pack contains 1 single-use vial.
Pack sizes:
1x 1 ml
1x 5 ml
1x 10 ml
1x 20 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
BN22 9AG, United Kingdom
Manufacturer: Actavis Italy S.p.A,
Via Pasteur 10, Nerviano (Milan),
20014, Italy
This leaflet was last revised in 02/2017
PL 00289/2134

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Preparation
• Chemotherapeutic agents should
be prepared for administration
only by professionals trained in the
safe use of the preparation.
• Operations such as dilution and
transfer to syringes should be carried
out only in the designated area.
• The personnel carrying out these
procedures should be adequately
protected with clothing, gloves
and eye shield.
• Pregnant personnel are advised
not to handle chemotherapeutic
agents.
Disposal and Contamination
To destroy, place in a high risk (for
cytotoxics) waste disposal bag and
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incinerate at 1100ºC.
If spills occur, restrict access to the
affected area and adequate protection
including gloves and safety spectacles
should be worn. Limit the spread and
clean the area with absorbent
paper/material. Spills may also be
treated with 5% sodium hypochlorite.
The spill area should be cleaned with
copious amounts of water. Place the
contaminated material in a leak proof
disposal bag for cytotoxics and
incinerate at 1100ºC.
Any unused medicinal product or
waste material should be disposed of
in accordance with local
requirements for cytotoxic agents.
32214-A

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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