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Cytarabine 20 mg/ml Injection

In this leaflet:
1. What Cytarabine Injection is and what it is used for
2. What you need to know before you use Cytarabine Injection
3. How to use Cytarabine Injection
4. Possible side effects
5. How to store Cytarabine Injection
6. Contents of the pack and other information

Cytarabine Injection is an anti-cancer medicine. Treatment with an anti-cancer
medicine is sometimes called cancer chemotherapy.
Cytarabine Injection is used to treat some types of leukaemia (cancer affecting
the blood) and lymphomas (cancer of the lymph glands). It may be used in
combination with other anti-cancer medicines.

Do not use Cytarabine Injection

• if you have shown signs of hypersensitivity (severe allergy) to cytarabine in
the past, or any of the other ingredients of this medicine (listed in section 6)
• if your blood cell count (number of cells in your blood) is very low due to
some cause other than cancer (unless your doctor decides the benefits of
treatment outweigh the risks)
• if you are feeling increasing difficulties in body coordination after radiation
treatment or treatment with another anticancer medicine such as methotrexate
• if you are pregnant
Tell your doctor if you think any of the above applies to you before this medicine
is used.

Take special care with Cytarabine Injection

• if your blood cell count is low
• if you have any problems with your liver including jaundice
(causes yellowing of the skin)
• if you have recently received cancer medicine treatment or radiotherapy or
if you are due to have radiotherapy (the side effects of radiotherapy can be
made worse by cytarabine treatment)
• Cytarabine strongly reduces blood cell production in the bone marrow and
your 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.
• if your bone marrow is still recovering from the effects of other
medicines (your doctor will only consider treatment with cytarabine if
absolutely necessary)
• Serious and sometimes life-threatening side effects can occur in the central
nervous system, the bowels, the lungs or the heart especially when treated
with high doses of cytarabine.
• 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 certain vaccines is not
advised. 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.
• During treatment with cytarabine granulocyte transfusion should be avoided
as severe respiratory insufficiency has been reported. If required, consult
your doctor.
Tell your doctor if any of the above applies to you before this medicine is used.
Your doctor will monitor your blood to check your blood cell count, your liver and
kidney functions and to monitor for raised uric acid levels.
Special care will be taken if cytarabine is to be given to a child. Cytarabine
should not be used in infants.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could
interact with cytarabine.
The effectiveness of the following medicines may be reduced or increased
by cytarabine:
• methotrexate (a medicine used to treat a range of cancers and some
inflammatory conditions)
• digoxin or beta-acetyldigoxin tablets (heart medicine)
• gentamicin (an antibiotic)
• 5-fluorocytosine (a medicine used to treat fungal infections)
• medicines containing cyclophosphamide, vincristine and prednisone which
are used in cancer treatment programmes
• other medicines which decrease the activity of the immune system
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. Your doctor will decide if you should receive this medicine.
Avoid becoming pregnant while you or your partner is being treated with
cytarabine. As there is a risk of birth defects, women of childbearing potential
or their partner should use appropriate contraception methods during and up to
6 months after treatment with cytarabine to prevent pregnancy.
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.

Driving and using machines
Do not drive or use machines if you experience any side effect which may
lessen your ability to do so.

Important information about one of the ingredients of
Cytarabine Injection
This medicinal product contains 2.1 mmol sodium (48 mg) per 350 mg dose. To
be taken into consideration by patients on a controlled sodium diet.

This medicine may be given by injection (using a syringe) under the skin
(subcutaneous), into a vein (intravenous) or into the spine (intrathecal). It may
also be given by infusion (drip) into a vein. If given as an infusion, Cytarabine
Injection will be diluted first.

Your doctor will work out the correct dose of cytarabine for you and how often it
must be given.
The dose will depend on your medical condition, your size and how well your liver
is working. Your doctor will tell how well your liver is working using blood tests.
You will have regular blood tests after your dose of cytarabine to check for side
effects. These tests may be done more often if you are elderly, as you may be
more likely to get side effects. Treatment may have to be stopped if your blood
cell count drops too low.

If you are given too much or too little Cytarabine Injection
This medicine will be given to you in a hospital, under the supervision of a
doctor. It is unlikely that you will be given too much or too little, however, tell
your doctor or nurse if you have any concerns.

Like all medicines, Cytarabine Injection can cause side effects, although not
everybody gets them.

If any of the following happen, tell your doctor or nursing staff

• sore mouth, particularly if you have a number of ulcers inside of the mouth
• severe allergic reaction - you may experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing), and you may feel you are going to faint
• symptoms of an infection, e.g. fever, chills, aches or soreness
when swallowing
• unexpected bleeding e.g. bleeding gums, blood in urine or vomit,
unexpected bruises
• black tarry stools which may indicate bleeding in the digestive system
• severe pain in the chest and difficulty breathing (this may be a symptom
of pericarditis)

Cytarabine 20 mg/ml Injection
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Solutions of cytarabine have been reported to be incompatible with various
drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin
sulphate, heparin sodium, hydrocortisone sodium succinate, insulin-regular,
methylprednisolone sodium succinate, nafacillin sodium, oxacillin sodium,
penicillin G sodium. However, the incompatibility depends on several factors

read direction

Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

• severe pain in the abdomen (this may be a symptom of inflammation of
the pancreas)
• loss of vision, 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.

If you experience any of the following tell your doctor as soon
as possible:
The side effects of cytarabine are dependent on the dose. The digestive tract is
most commonly affected, but also the blood.
Common side effects which may affect up to 1 person in 10 are
listed below:
• decrease in cells responsible for providing immunity, carrying oxygen around
the body and for normal blood clotting shown as a reduction in the amount
of red and white cells and platelets in the blood, anaemia, shortness of
breath, unexpected bleeding e.g. bleeding gums, blood in urine or vomit,
unexpected bruises
• loss of appetite
• high levels of uric acid due to the breakdown of cancer cells during treatment
with cytarabine
• reduced consciousness, speaking difficulties, abnormal eye
movements (nystagmus)
• reversible effects on the eyes such as sore eyes with bleeding (haemorrhagic
conjunctivitis), vision disturbance, sensitivity to light (photophobia), watery or
burning eyes and inflammation of the cornea (keratitis)
• feeling or being sick (this side effect may be reduced if cytarabine is given as an
infusion into a vein rather than an injection into a vein), diarrhoea, sore mouth
or anus (back passage), ulcers in the mouth or anus, mild pain in the abdomen
• reversible effects on the liver such as increased enzyme levels
• reversible effects to the skin such as reddening (erythema), blistering, rash,
hives, blood vessel inflammation (vasculitis)
• hair loss
• impaired/disturbed kidney function, problems passing urine
• fever
• blood clots causing inflammation at the site of injection
Uncommon side effects which may affect up to 1 person in 100 are
listed below:
• whole body infection (sepsis) seen as a fever, vomiting, confusion,
dizziness, chills
• lung infection
• headache
• numbness or weakness of the arms and legs, paralysis of the legs and lower
body when cytarabine is given into the space surrounding the spinal cord
• inflammation of the sac that surrounds the heart
• shortness of breath
• sore throat
• inflammation of the food pipe (oesophagus), ulcers in the food pipe
• bowel cysts (pneumatosis cystoides intestinalis), severe bowel inflammation
(necrotising colitis), serious infection of the membrane that lines the
abdomen (peritonitis)
• brown/black spots on the skin (lentigo), ulceration of the skin, itching
• painful redness and blistering on the hands and the soles of the feet
• joint and muscle pain
• inflammation at the injection site
Very rare side effects which may affect up to 1 person in 10,000 are
listed below:
• irregular heart beat (arrhythmia)
• redness and itchy bumps on hands or legs, associated with inflammation of
the sweat glands (neutrophilic eccrine hidradenitis)
Not known (cannot be estimated from available data) side effects are
listed below:
• bone marrow suppression, low counts of pre-stages of red cells in the blood
(reticulocytopenia), abnormal blood cells (megaloblastosis)
• dizziness, inflammation of a nerve or part of the nervous system, damage to
nerve tissues and pain
• sore or itchy eyes
• black tarry stools which may indicate bleeding in the digestive system
• impaired liver function
• yellowing of the skin or yellowing of the whites of the eyes (jaundice)
• skin rash, pigmented spots on the skin (freckles), skin bleeding
• kidneys may not work properly
• chest pain
• irritation or severe blood infection (sepsis) at the site of injection,
mucosal bleeding
Severe and at times fatal side effects on the blood, eyes, lungs, nervous
system, liver, digestive or genital system have been reported after using
experimental dose schedules. The side effects have included severe bone
marrow suppression, reversible effects on the cornea (front of the eye),
effects on the brain (usually reversible), drowsiness and convulsion, ulcers
in the digestive system which may lead to the infection of your abdominal
fluid (peritonitis), inflammation of the pancreas, abscess or blood clots in
a vein in the liver, blood infection, fluid in the lungs, absence of menstrual
periods in women or complete lack of sperm in the ejaculate in men, heart
muscle disease or abnormal muscle breakdown, which may lead to kidney
problems (rhabdomyolysis).
The side effects on the digestive tract are less if cytarabine is given by
infusion. Your doctor may prescribe local corticosteroids (anti-inflammatory
medicines) to prevent effects on the eyes such as sore eyes with bleeding
(haemorrhagic conjunctivitis).
Cytarabine may lead to changes in your blood cells. Your doctor will take
blood samples to monitor for these and also to check how well your liver and
kidneys are working.
Sometimes the following side effects can occur together, usually 6-12 hours
after receiving cytarabine:
• feeling generally unwell with a high temperature
• pain in bone, muscle and occasionally the chest
• rash
• sore eyes
This is known as ‘cytarabine syndrome’ and it can be treated. If you experience
these side effects please tell your doctor or nurse as soon as possible.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

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:
United Kingdom
Yellow Card Scheme
ADR Reporting
By reporting side effects you can help provide more information on the safety of
this medicine.

Keep out of the reach and sight of children

This medicine must not be used after the expiry date which is stated on the vial
label and carton after ‘EXP’. Where only a month and year is stated, the expiry
date refers to the last day of that month.

The vial should be kept in the outer carton, in order to protect from light, and
stored at a temperature not above 25°C.

What Cytarabine Injection contains
The active substance is cytarabine. Each millilitre (ml) of solution contains
20 milligrams (mg) of cytarabine.
The other ingredients are sodium chloride and Water for Injections. See section
2 ‘Important information about one of the ingredients of Cytarabine Injection’ for
further information about the sodium content.

What Cytarabine Injection looks like and contents of the pack
Cytarabine Injection is a clear, colourless solution for injection which comes in
glass containers called vials.
It may be supplied in packs containing:
5, 25 or 50 x 100 mg/5 ml vials
5, 25 or 50 x 500 mg/25 ml vials
5, 25 or 50 x 1 g/50 ml vials
Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
This leaflet was last revised in 06/2016

(e.g. concentrations of the drug, specific diluents used, resulting pH, temperature).
Specialised references should be consulted for specific compatibility information.

Use and handling
Cytarabine 20 mg/ml Injection is a ready to use solution but it can be diluted with
sterilised Water for Injections BP, Glucose Intravenous Infusion BP or Sodium
Chloride Intravenous Infusion BP.
Chemical and physical in-use stability has been demonstrated for 7 days at
room temperature.
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.

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.