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CYTARABINE 20MG/ML INJECTION

Active substance(s): CYTARABINE

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Package leaflet:
Information for the user
Cytarabine 20 mg/ml Injection
cytarabine

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.
You must talk to a doctor if you do not feel better or if you feel worse

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE
INJECTION
Do not use Cytarabine Injection

• if you are allergic to cytarabine 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cytarabine Injection.

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 (hyperuricemia) 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.

Other medicines and Cytarabine Injection
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines as special care is needed if you are taking or
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-acetyl digoxin 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

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning
to have a baby, ask your doctor or pharmacist for advice before taking 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.

Cytarabine Injection contains sodium
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.

3. HOW TO USE CYTARABINE INJECTION
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.

Recommended Dose
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 use more Cytarabine Injection than you should
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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

• 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

Cytarabine 20mg/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.

Incompatibilities
Solutions of cytarabine have been reported to be incompatible with various
drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin
sulfate, heparin sodium, hydrocortisone sodium succinate, insulin-regular,
methylprednisolone, sodium succinate, nafacillin sodium, oxacillin sodium,
penicillin G sodium. However, the incompatibility depends on several factors (e.g.
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1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR

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What is 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

FPO

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 or pharmacist.
• 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 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 chest and difficulty breathing (this may be a symptom
of pericarditis)
• 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: may affect up to 1 in 10 people
• 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: may affect up to 1 in 100 people
• 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
(intrathecal)
• 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: may affect up to 1 in 10,000 people
• irregular heart beat (arrhythmia)
• redness and itchy bumps on hands or legs, associated with inflammation of
the sweat glands (neutrophilic eccrine hidradenitis)
Not known: frequency cannot be estimated from the available data
• 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
• slower heartbeat
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side affects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE CYTARABINE INJECTION
Keep this medicine out of the sight and reach of children.

Expiry
Do not use this medicine 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.
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.

Storage
Do not store above 25°C.Keep in the outer carton to protect from light.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
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, Water for Injections, Hydrochloric Acid
and Sodium Hydroxide (see section 2 Cytarabine Injection contains sodium).

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 09/2017
Ref: gxCY 3_4
GUJ-DRUGS/G/28/1267
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.
Ref: gxCY 3_4
PAR13410I

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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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