CYTARABINE 100MG/ML

Active substance: CYTARABINE

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INFORMATION FOR MEDICAL STAFF

Cytarabine

20mg/ml and 100mg/ml
Solution for infusion or injection
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4.3 Contra-indications

Therapy with Cytarabine should not be considered in
patients with pre-existing drug-induced bone marrow
suppression, unless the clinician feels that such
management offers the most hopeful alternative for the
patient. Cytarabine should not be used in the management
of non-malignant disease, except for immunosuppression.
Cytarabine is contraindicated in those patients who are
hypersensitive to Cytarabine or to any of the excipients
listed in section 6.1.

1. TRADE NAME OF THE MEDICINAL
PRODUCT
Cytarabine 20mg/ml
Cytarabine 100mg/ml

2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
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1 ml of solution contains 20mg of cytarabine.
1 ml of solution contains 100mg of cytarabine.
For a full list of excipients see Section 6.1

3. PHARMACEUTICAL FORM
Solution for infusion or injection.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications

Cytotoxic. For induction of remission in acute myeloid
leukaemia in adults and for other acute leukaemias of
adults and children.
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4.2 Posology and method of administration

By intravenous infusion or injection, or subcutaneous
injection.
Dosage recommendations may be converted from those
in terms of bodyweight to those related to surface area by
means of nomograms, as presented in Documenta Geigy.
1) Remission induction:
a) Continuous treatment:
i) Rapid injection - 2 mg/kg/day is a judicious starting
dose. Administer for 10 days. Obtain daily blood
counts. If no antileukaemic effect is noted and there
is no apparent toxicity, increase to 4 mg/kg/day and
maintain until therapeutic response or toxicity is
evident. Almost all patients can be carried to toxicity
with these doses.
ii) 0.5 - 1.0 mg/kg/day may be given in an infusion
of up to 24 hours duration. Results from one hour
infusions have been satisfactory in the majority of
patients. After 10 days this initial daily dose may be
increased to 2 mg/kg/day subject to toxicity. Continue
to toxicity or until remission occurs.
b) Intermittent treatment:
3 - 5 mg/kg/day are administered intravenously on
each of five consecutive days. After a two to nine day
rest period, a further course is given. Continue until
response or toxicity occurs.
The first evidence of marrow improvement has been
reported to occur 7 - 64 days (mean 28 days) after the
beginning of therapy.
In general, if a patient shows neither toxicity nor
remission after a fair trial, the cautious administration
of higher doses is warranted. As a rule, patients have
been seen to tolerate higher doses when given by rapid
intravenous injection as compared with slow infusion.
This difference is due to the rapid metabolism of
Cytarabine and the consequent short duration of action
of the high dose.
2) Maintenance therapy: Remissions which have been
induced by Cytarabine, or by other drugs, may be
maintained by intravenous or subcutaneous injection of
1 mg/kg once or twice weekly.
Children: Children appear to tolerate higher doses than
adults and, where dose ranges are quoted, the children
should receive the higher dose and the adults the
lower.
Elderly Patients: There is no information to suggest
that a change in dosage is warranted in the elderly.
Nevertheless, the elderly patient does not tolerate
drug toxicity as well as the younger patient, and
particular attention should thus be given to drug
induced leucopenia, thrombocytopenia, and anaemia,
with appropriate initiation of supportive therapy when
indicated.

4.4 Special warnings and special
precautions for use

General: Only physicians experienced in cancer
chemotherapy should use cytarabine.
Warnings: Cytarabine is a potent bone marrow
suppressant; the severity depends on the dose of the drug
and schedule of administration. Therapy should be started
cautiously in patients with pre-existing drug-induced bone
marrow suppression. Patients receiving this drug must
be under close medical supervision and, during induction
therapy, should have leucocyte and platelet counts
performed daily. Bone marrow examinations should be
performed frequently after blasts have disappeared from
the peripheral blood.
The main toxic effect of cytarabine is bone marrow
suppression with leukopenia, thrombocytopenia and
anemia. Less serious toxicity includes nausea, vomiting,
diarrhoea and abdominal pain, oral ulceration, and hepatic
dysfunction.
Following 5-day constant infusions or acute injections of
50 mg/m² to 600 mg/m², white cell depression follows a
biphasic course. Regardless of initial count, dosage level,
or schedule, there is an initial fall starting the first 24 hours
with a nadir at days 7-9. This is followed by a brief rise
which peaks around the twelfth day. A second and deeper
fall reaches nadir at days 15-24. Then there is rapid rise
to above baseline in the next 10 days. Platelet depression
is noticeable at 5 days with a peak depression occurring
between days 12-15. Thereupon, a rapid rise to above
baseline occurs in the next 10 days.
Facilities should be available for management of
complications, possibly fatal, of bone marrow suppression
(infection resulting from granulocytopenia and other
impaired body defences, and haemorrhage secondary to
thrombocytopenia). Anaphylactic reactions have occurred
with cytarabine treatment. Anaphylaxis that resulted in
acute cardiopulmonary arrest and required resuscitation
has been reported. This occurred immediately after the
intravenous administration of Cytarabine (see section 4.8).
Severe and at times fatal CNS, GI and pulmonary toxicity
(different from that seen with conventional therapy
regimens of Cytarabine) has been reported following
some experimental high dose (2-3 g/m²) schedules with
Cytarabine. These reactions include reversible corneal
toxicity; cerebral and cerebellar dysfunction, usually
reversible; somnolence; convulsion; severe gastrointestinal
ulceration, including pneumatosis cystoides intestinalis,
leading to peritonitis; sepsis and liver abscess; and
pulmonary oedema (see section 4.8).
Cytarabine has been shown to be carcinogenic in animals.
The possibility of a similar effect should be borne in mind
when designing the long-term management of the patient.
Precautions: Patients receiving Cytarabine must be
monitored closely. Frequent platelet and leucocyte counts
are mandatory. Suspend or modify therapy when drug
induced marrow depression has resulted in a platelet count
under 50,000 or a polymorphonuclear granulocyte count
under 1,000 per cubic mm. Counts of formed elements in
the peripheral blood may continue to fall after the drug is
stopped, and reach lowest values after drug-free intervals
of 12 to 24 days. If indicated, restart therapy when definite
signs of marrow recovery appear (on successive bone
marrow studies). Patients whose drug is withheld until

‘normal’ peripheral blood values are attained may escape
from control.
Peripheral motor and sensory neuropathies after
consolidation with high doses of cytarabine, daunorubicin,
and asparaginase have occurred in adult patients with acute
non lymphocytic leukemia. Patients treated with high doses
of cytarabine should be observed for neuropathy since dose
schedule alterations may be needed to avoid irreversible
neurologic disorders.
Severe and sometimes fatal pulmonary toxicity, sudden
respiratory distress syndrome and pulmonary oedema have
occurred following experimental high dose schedules with
cytarabine therapy.
Cases of cardiomyopathy with subsequent death have been
reported following experimental high dose cytarabine and
cyclophosphamide therapy when used for bone marrow
transplant preparation. This may be schedule dependent.
When intravenous doses are given quickly, patients are
frequently nauseated and may vomit for several hours
afterwards. This problem tends to be less severe when the
drug is infused.
Abdominal tenderness (peritonitis) and guaiac positive
colitis, with concurrent neutropenia and thrombocytopenia,
have been reported in patients treated with conventional
doses of cytarabine in combination with other drugs.
Patients have responded to nonoperative medical
management. Delayed progressive ascending paralysis
resulting in death has been reported in children with
AML following intrathecal and intravenous cytarabine at
conventional doses in combination with other drugs.
The human liver apparently detoxifies a substantial fraction
of an administered dose of cytarabine. In particular, patients
with renal or hepatic function impairment may have a higher
likelihood of CNS toxicity after high-dose treatment with
cytarabine. Use the drug with caution and at reduced dose in
patients whose liver function is poor.
Periodic checks of bone marrow, liver and kidney functions
should be performed in patients receiving Cytarabine.
The safety of this drug for use in infants is not established.
Like other cytotoxic drugs, Cytarabine may induce
hyperuricaemia secondary to rapid lysis of neoplastic
cells. The clinician should monitor the patient’s blood uric
acid level and be prepared to use such supportive and
pharmacological measures as may be necessary to control
this problem.
Immunosuppressant Effects/Increased Susceptibility to
Infections. Administration of live or live-attenuated vaccines
in patients immunocompromised by chemotherapeutic
agents including cytarabine, may result in serious or fatal
infections. Vaccination with a live vaccine should be avoided
in patients receiving cytarabine. Killed or inactivated
vaccines may be administered; however, the response to
such vaccines may be diminished.

4.5 Interaction with Other Medicaments
and Other Forms of Interaction

5-Fluorocytosine should not be administered with Cytarabine
as the therapeutic efficacy of 5-Fluorocytosine has been
shown to be abolished during such therapy.
Reversible decreases in steady-state plasma digoxin
concentrations and renal glycoside excretion were observed
in patients receiving beta-acetyldigoxin and chemotherapy
regimens containing cyclophosphamide, vincristine and
prednisone with or without Cytarabine or procarbazine.
Steady-state plasma digitoxin concentrations did not appear
to change. Therefore, monitoring of plasma digoxin levels
may be indicated in patients receiving similar combination
chemotherapy regimens. The utilisation of digitoxin for such
patients may be considered as an alternative.
An in-vitro interaction study between gentamicin and
Cytarabine showed a Cytarabine related antagonism for
the susceptibility of K.pneumoniae strains. In patients
on Cytarabine being treated with gentamicin for a
K.pneumoniae infection, a lack of a prompt therapeutic
response may indicate the need for re-evaluation of
antibacterial therapy.

4.6 Pregnancy and Lactation

Cytarabine is known to be teratogenic in some animal
species. The use of Cytarabine in women who are, or who
may become, pregnant should be undertaken only after due
consideration of the potential benefits and hazards.
Because of the potential for abnormalities with cytotoxic
therapy, particularly during the first trimester, a patient
who is or who may become pregnant while on cytarabine

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should be apprised of the potential risk to the fetus and
the advisability of preganancy continuation. There is
a definite, but considerably reduced risk if therapy is
initiated during the second or third trimester. Although
normal infants have been delivered to patients treated
in all three trimesters of pregnancy, follow-up of such
infants would be advisable.
Nursing Mothers
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk
and because of the potential for serious adverse reactions
in nursing infants from cytarabine, a decision should be
made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of the drug
to the mother.
This product should not normally be administered to
patients who are pregnant or to mothers who are breastfeeding.

PATIENT INFORMATION LEAFLET

4.7 Effects on ability to drive and use
machines

• 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. Do not pass it on to others. It may
harm them, even if their symptoms
are the same as yours.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Cytarabine has no effect on intellectual function or
psychomotor performance. Nevertheless, patients
receiving chemotherapy may have an impaired ability to
drive or operate machinery and should be warned of the
possibility and advised to avoid such tasks if so affected.

4.8 Undesirable effects

Most frequent adverse reactions include nausea,
vomiting, diarrhoea, fever, rash, anorexia, oral and anal
inflammation or ulceration, and hepatic dysfunction.
Blood and lymphatic system disorders: Because
Cytarabine is a bone marrow suppressant, anaemia,
leucopenia, thrombocytopenia, megaloblastosis and
reduced reticulocytes can be expected as a result of
its administration. The severity of these reactions are
dose and schedule dependent. Cellular changes in the
morphology of bone marrow and peripheral smears can
be expected.
- Infections and infestations: Pneumonia, sepsis,
cellulitis at injection site, liver abscess
- Immune system disorders: Anaphylaxis, allergic
oedema
- Metabolism and nutrition disorders: Anorexia
- Nervous system disorders: Neural toxicity, neuritis,
dizziness, headache
- Eye disorders: Conjunctivitis (may occur with rash)
- Cardiac disorders: Pericarditis
- Vascular disorders: Thrombophlebitis
- Respiratory, thoracic and mediastinal disorders:
Shortness of breath, sore throat
- Gastrointestinal disorders: Pancreatitis, esophageal
ulceration, abdominal pain, diarrhoea, esophagitis,
nausea/vomiting, oral and anal inflammation or
ulceration
- Hepatobiliary disorders: Hepatic dysfunction, jaundice
- Skin and subcutaneous tissue disorders: Skin
ulceration, alopecia, freckling, rash, pruritus, urticaria
- Renal and urinary disorders: Renal dysfunction,
urinary retention
- General disorders and administration site conditions:
Chest pain, fever, injection site reaction (pain and
inflammation at subcutaneous injection sites)
High Dose Therapy (see section 4.4)
- Infections and infestations: Sepsis, liver abscess
- Nervous system disorders: Coma, cerebral and
cerebellar dysfunction including personality changes,
somnolence, and convulsion; peripheral motor and
sensory neuropathies.
- Eye disorders: Corneal toxicity, conjunctivitis
- Cardiac disorders: Cardiomyopathy with subsequent
death
- Respiratory, thoracic and mediastinal disorders: Adult
respiratory distress syndrome, pulmonary oedema
- Gastrointestinal disorders: Gastrointestinal necrosis,
necrotizing colitis, gastrointestinal ulceration
(including pneumatosis cystoides intestinalis leading
to peritonitis)
- Hepatobiliary disorders: Liver damage with increased
hyperbilirubinemia
- Skin and subcutaneous tissue disorders: Skin rash
leading to desquamation, alopecia

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Driving and using machinery

Cytarabine

20mg/ml and 100mg/ml
Solution for infusion or injection
Read all of this leaflet carefully
before you start taking this
medicine.

In this leaflet:

1. What Cytarabine is and what it is
used for
2. Before you are given Cytarabine
3. How Cytarabine is given to you
4. Possible side effects
5. How to store Cytarabine
6. Further information

1. What Cytarabine is and
what it is used for

• Cytarabine is used in adults and children.
The active ingredient is cytarabine.
• Cytarabine 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
leukaemia.
• 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.

2. Before you are given
Cytarabine
Do not use Cytarabine if you:

• are allergic (hypersensitive) to cytarabine,
or any of the other ingredients of Cytarabine
20mg/ml and 100mg/ml Solution for
Injection.
• are already taking medicines that have
caused you to have a low blood count
caused by suppression of your bone
marrow.

Take special care with Cytarabine:

• Tell your doctor if your liver is not working
properly. This will help your doctor decide if
Cytarabine is suitable for you.
• If you have had or are due to have any
vaccination including a live or liveattenuated vaccination.

Taking other medicines

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 or have recently taken any other
medicines, even those not prescribed.

Pregnancy

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. Cytarabine may cause birth defects,
so it is important to tell your doctor if you think
you are pregnant.

Breast-feeding

You should stop breast-feeding before starting
treatment with Cytarabine because this
medicine may be harmful to infants being
breast-fed.
Ask your doctor or pharmacist for advice
before taking any medicine.

If feeling unwell following treatment with
Cytarabine you should avoid driving or using
machinery.
Ask your doctor or pharmacist for advice
before taking any medicine.

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 - again using blood tests - to
check that Cytarabine is not affecting the
way it functions in a harmful way.
• Your kidneys - again 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
Cytarabine:

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.

4. Possible side effects

Like all cytotoxic medicines, Cytarabine
causes side effects, although these can vary
from patient to patient.
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.

FRONT

• 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
symptoms.

Other side effects that may occur
are:

If any of these side effects gets serious
please tell your doctor or nursing staff
immediately.
• Reactions at Injection site:
inflammation to your veins (caused by a
blood clot).
• Effects on your nervous system:
Headaches or feeling dizzy, feeling of pins
and needles, shaking and fits, drowsiness,
experience problems in walking, speech
problems, involuntary muscular movement,
changes in your personality, tiredness,
weakness, fainting.
• Effects on your skin and hair:
Hair loss is common and may be quite
severe. Hair normally re-grows when
your treatment course ends. A rash or
ulceration on your skin, peeling of the
skin, itching or increased freckles. You
may get an infection, including infection or
inflammation at the site of your injection.
• Effects on your stomach, intestines:
Feeling sick, being sick, diarrhoea, loss of
appetite, abdominal pain.
• Effects on your mouth, gullet and
anus: Inflammation of the gullet, causing
heartburn may make you feel sick, and the
appearance of sores in the mouth, lips, or
on the anus (back passage).
• Effects on your pancreas: Pancreatitis
(pain in the upper abdomen) often
accompanied by feeling sick or vomiting.
Tell your doctor if this happens to you.
• Effects on your liver: Liver damage
(seen as yellowing of the skin and whites
of the eye).
• Effects on your kidneys, bladder and
urine: Difficulty or pain when passing
urine. Blood in your urine and impaired
kidney function.
• Effects on your hands, face and body:
Feeling hot and feverish, conjunctivitis, and
pain and numbness in joints, fingers, toes
or face, swelling of the abdomen, legs,
ankles and feet.
• Effects on respiratory system and
chest: Shortness of breath, pneumonia,
short or stabbing chest pain, build up of
fluid in the lungs, sore throat.
• Effects on your muscles and bone:
muscle pain, bone pain.
• Effects on your heart and circulation:
fast heart beat, pericarditis (inflammation
of the covering of the heart).
• Effects on your eyes and vision: eye
infection, irritation, pain and blurred vision,
visual loss.

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BACK

“Cytarabine Syndrome”
Sometimes the following side effects can
happen together 6 to 12 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.
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
nursing staff immediately.

5. How to store Cytarabine

Keep out of the reach and sight of
children.
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 stamped on the pack.
The expiry date refers to the last day of that
month.
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.

Marketing Authorisation Holder:

A diffuse interstitial pneumonitis without clear cause
that may have been related to cytarabine was reported
in patients treated with experimental intermediate
doses of cytarabine (1g/m²) with and without other
chemotherapeutic agents (meta-AMSA, daunorubicin,
VP-16).
A syndrome of sudden respiratory distress, rapidly
progressing to pulmonary oedema and a radiographically
pronounced cardiomegaly has been reported following
experimental high dose therapy with cytarabine used for
the treatment of relapsed leukemia; fatal outcome has
been reported.
Viral, bacterial, fungal, parasitic, or saprophytic
infections, in any location in the body, may be associated
with the use of Cytarabine alone or in combination
with other immunosuppressive agents following
immunosuppressant doses that affect cellular or humoral
immunity. These infections may be mild, but can be
severe and at times fatal.
A Cytarabine syndrome has been described. It is
characterised by fever, myalgia, bone pain, occasionally
chest pain, maculopapular rash, conjunctivitis and
malaise. It usually occurs 6 - 12 hours following drug
administration. Corticosteroids have been shown to be
beneficial in treating or preventing this syndrome. If the
symptoms of the syndrome are serious enough to warrant
treatment, corticosteroids should be contemplated as
well as continuation of therapy with Cytarabine.
Cases of pancreatitis have been observed with the
induction of Cytarabine.
Cytarabine is not recommended for intrathecal use;
however, the following side-effects have been reported
with such use. Expected systemic reactions: bone
marrow depression, nausea, vomiting. Occasionally,
severe spinal cord toxicity even leading to quadriplegia
and paralysis, necrotising encephalopathy, with or
without convulsion, blindness and other isolated
neurotoxicities have been reported.

Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer:

Pfizer Service Company BVBA
10 Hoge Wei
1930 Zaventem
Belgium

Company Contact address:

If you have any comments on the way this
leaflet is written, please contact Medical
Information at Pfizer Limited in Walton Oaks,
Tadworth, Surrey, Tel: 01304 616161.
This leaflet was last revised in: 08/2013
Ref: CC 10_2

4.9 Overdose

Cessation of therapy, followed by management of
ensuing bone marrow depression including whole blood
or platelet transfusion and antibiotics as required. There
is no antidote for overdosage of cytarabine. Doses of
4.5g/m² by intravenous infusion over 1 hour every 12
hours for 12 doses has caused an unacceptable increase
in irreversible CNS toxicity and death.

6. Further 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
chloride.
The other ingredients in Cytarabine
100mg/ml are hydrochloric acid, sodium
hydroxide, nitrogen and water for injections.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

ATC Code: L01BC01
Cytarabine, a pyrimidine nucleoside analogue, is an
antineoplastic agent which inhibits the synthesis
of deoxyribonucleic acid. It also has antiviral and
immunosuppressant properties. Detailed studies on
the mechanism of cytotoxicity in vitro suggests that the
primary action of Cytarabine is inhibition of deoxycytidine
synthesis, although inhibition of cytidylic kinases and
incorporation of the compound into nucleic acids may
also play a role in its cytostatic and cytocidal actions.

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 (25ml).
Cytarabine containing 100mg/ml is supplied
in plastic vials containing 1000mg (10ml) or
2000mg (20ml).

5.2 Pharmacokinetic properties

Cytarabine is deaminated to arabinofuranosyl uracil in
the liver and kidneys. After intravenous administration to
humans, only 5.8% of the administered doses is excreted
unaltered in urine within 12 - 24 hours, 90% of the
dose is excreted as the deaminated product. Cytarabine
appears to be metabolised rapidly, primarily by the liver
and perhaps by the kidney. After single high intravenous
doses, blood levels fall to unmeasurable levels within
15 minutes in most patients. Some patients have in
demonstrable circulating drug as early as 5 minutes after
injection.

5.3 Preclinical Safety Data

Cytarabine is embryotoxic and teratogenic when
administered to rodents during the period of
organogenesis at clinically relevant doses. It is reported
that cytarabine causes developmental toxicity, including
damage to the developing brain, when administered
during the peri- and postnatal period. No formal fertility
studies have been reported however sperm head
abnormalities were observed following cytarabine
treatment in mice.
Cytarabine is mutagenic and clastogenic and produced
malignant transformation of rodent cells in vitro.
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6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Cytarabine 20mg/ml
Hydrochloric Acid
Sodium Hydroxide
Nitrogen
Water for injections
Sodium Chloride

Cytarabine 100mg/ml
Hydrochloric Acid
Sodium Hydroxide
Nitrogen
Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal products
except those mentioned in section 6.6.

6.3 Shelf-life

Cytarabine 20mg/ml
Cytarabine 100mg/ml

12 months
18 months

6.4 Special precautions for storage

Store at 15°C - 25°C. Keep container in outer carton.
Cytarabine should not be stored at refrigerated temperatures
(2-8ºC).

6.5 Nature and contents of container

Polypropylene vials, closed with either a West S63/1704
Grey EPDM rubber stopper or a West 4110/40 Grey
FluroTec® Plus-faced rubber stopper, and sealed with an
aluminium crimp with a plastic flip-off top.
Cytarabine 20mg/ml
Cytarabine is supplied as vials containing 20mg/ml
cytarabine in 5ml (100mg) in packs of 5, or 25ml (500mg)
as single vials.
Cytarabine 100mg/ml
Cytarabine is supplied as single vials containing 100mg/ml
cytarabine in 10ml (1g) or 20ml (2g).

6.6 Instructions for use, handling and
disposal

Cytarabine 100mg/ml only:
Prior to use, vials of Cytarabine 100mg/ml must be warmed
to 55°C, for 30 minutes, with adequate shaking, and allowed
to cool to room temperature.
Cytarabine 20mg/ml & 100mg/ml:
Once opened, the contents of each vial must be used
immediately and not stored. Discard any unused portion.
Water for injections, 0.9% saline or 5% dextrose are
commonly used infusion fluids for Cytarabine. Compatibility
must be assured before mixing with any other substance.
Infusion fluids containing Cytarabine should be used
immediately.
Disposal and Spills: To destroy, place in a high risk (for
cytotoxics) waste disposal bag and 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.

7. MARKETING AUTHORISATION HOLDER

Pharmacia Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK

8. MARKETING AUTHORISATION NUMBER
Cytarabine 20mg/ml
Cytarabine 100mg/ml

PL 00032/0197
PL 00032/0198

9. DATE OF FIRST AUTHORISATION/
RENEWAL OF AUTHORISATION
03 June 1999

10. DATE OF REVISION OF THE TEXT
08/2013

LEGAL CATEGORY
POM
Ref: CC 10_2

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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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