2. What should I know before treatment with Cytarabine Injection?
Do not use if you have ever had an allergic reaction to Cytarabine Injection or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Cytarabine Injection
should not be used in pregnant women or women whose partners are receiving treatment,
and for a period after treatment stops. Women should not breastfeed when being treated
with Cytarabine Injection or for at least a week after treatment stops. For more information, see Section
2. What should I know before treatment with Cytarabine Injection? in the full CMI.
3. What if I am taking other medicines?
4. How is Cytarabine Injection given?
5. What should I know during treatment with Cytarabine Injection?
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Things you should do
|
Tell your doctor straight away if you experience severe side effects.
Use a reliable form of contraception during treatment and for a period afterwards.
Tell your doctor immediately if you or your partner becomes pregnant while either
of you are being treated with Cytarabine Injection.
Remind any doctor or pharmacist who are treating you that you are being treated with
Cytarabine Injection.
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Things you should not do
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Do not take any other medicines, or vaccines, whether they require a prescription
or not without first telling your doctor or consulting with a pharmacist.
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Driving or using machines
|
Do not drive, operate machinery or do anything else that could be dangerous until
you know how Cytarabine Injection affects you.
|
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Drinking alcohol
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No information is available
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6. Are there any side effects?
Side effects may include hot/tender/red skin or hard area under injection site; sore
throat, sore mouth/mouth ulceration; anal ulcer/inflammation; diarrhoea; vomiting,
nausea; constipation; sleepiness; cold hands/feet; sweating, chills , shivering; loss
of appetite; aching muscles; bone pain; hair loss; itching, rash, ulceration or peeling
of the skin; stomach pain; generally feeling unwell; freckling; fever; infection;
yellowish skin/eyes; irregular or rapid heart rate; difficulty passing urine; headache;
redness, swelling, tender palms of hands/soles of feet with thick calluses or blisters;
paralysis; cough with yellow/green/bloody mucus; dizziness/light-headedness; confusion,
change in mental status or personality; coordination /movement/balance problems; numbness;
trouble sleeping slurred speech; problems with vision; conjunctivitis or eye discomfort;
any unusual bruising or bleeding; bluish skin/lips/nails; swelling/skin colour changes
in hands/feet; severe upper or lower stomach pain; allergic reaction; shortness of
breath, fast/ shallow breathing, wheezing; chest pain; coma; convulsions.
Active ingredient(s):
cytarabine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Cytarabine Injection. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about being treated with Cytarabine
Injection.
Where to find information in this leaflet:
1. Why am I being treated with Cytarabine Injection?
Cytarabine Injection contains the active ingredient cytarabine, which is a synthetic
pyrimidine nucleoside. It is a cytotoxic agent, also referred to as chemotherapy medicine. It is used to
treat cancers by inhibiting DNA synthesis to kill the cancer cells and stop them from
growing and multiplying.
Cytarabine Injection is used to treat adults and children with:
leukaemia which is cancer of the blood and bone marrow
meningeal leukaemia/neoplasms, a form of brain cancer
2. What should I know before treatment with Cytarabine Injection?
Warnings
You should not be treated with Cytarabine Injection if:
you are allergic to cytarabine, or any of the ingredients listed at the end of this
leaflet.
Check with your doctor if you:
have had prior treatment with L-asparaginase
plan to have any vaccinations
have problems with your liver
have problems with your kidneys
plan to have children
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
Cytarabine Injection should not be used in pregnant woman as it may be harmful to
the fetus. Immediately inform your doctor if you or your partner are pregnant, or
intend to become pregnant.
Women should use effective contraception during treatment with Cytarabine Injection
and for at least 6 months after treatment.
Men should use effective contraception during treatment with Cytarabine Injection
and for at least 3 months after treatment.
Talk to your doctor about the need for additional contraception while being given
Cytarabine Injection.
Cytarabine Injection may affect male and female fertility. Check with your doctor
for advice on fertility preservation before you begin treatment.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breastfeed if you being given this medicine and for at least 1 week following
the last dose of treatment.
Cytarabine Injection may pass into breast milk and affect your baby.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with Cytarabine Injection and affect how it works. These
include:
L-asparaginase, a medicine used to treat certain cancer
Some other medicines used to treat cancer
methotrexate, a medicine used to treat psoriasis, arthritis and cancer
digoxin, a medicine used to treat heart problems
some medicines used to treat infections, including gentamicin
some vaccines
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect Cytarabine Injection.
4. How is Cytarabine Injection given?
How much is given
Your doctor will decide how much Cytarabine Injection you should receive and the length
of time for which you should receive it
How is Cytarabine Injection given
Cytarabine Injection can be given alone or as part of a treatment plan with other
chemotherapy medicines. It can be given in a number of different ways:
as a single injection into a vein
as a intravenous infusion (as a slow drip into a vein)
as a single injection under the skin, where different places should be used for each
injection
as a single injection into the space around the spinal cord
If you use too much Cytarabine Injection
Cytarabine Injection is given under the close supervision of your doctor, it is very
unlikely that you will receive too much. Symptoms of an overdose include: fever; muscle
or bone pain; chest pain; problems breathing; conjunctivitis, eye pain or discomfort,
problems with vision; vomiting, nausea; diarrhoea; severe skin rash; blood in your
stool (poo); problems with balance, movement, speech or thinking. If you experience
any side effects, tell your doctor or nurse immediately.
5. What should I know during treatment with Cytarabine Injection?
Things you should do
Keep all of your doctor’s appointments and attend any appointments and tests as directed
by your doctor, as treatment with Cytarabine Injection requires your doctor to monitor
your kidneys, liver and blood.
Tell your doctor straight away if you experience:
Infection
unusual bleeding or bruising
loss of movement
loss of or a change in sensation
loss of bowel or bladder control
headache
coma, stroke-like episodes
painful, swollen joints
severe upper or lower stomach pain, nausea, vomiting
severe mouth ulcers
diarrhoea (usually with blood and mucus)
fever
personality changes
severe and unusual sleepiness
coughing, difficulty breathing, wheezing
severe shortness of breath, unusual laboured and rapid breathing, cough, chest discomfort,
fast heart rate, confusion and extreme tiredness
fatigue, chest pain, and palpitations
severe skin rash, leading to peeling of the skin
Remind any doctor, nurse or dentist you visit that you are using Cytarabine Injection.
Things you should not do
Do not take any other medicines, including vaccines, whether they require a prescription
or not without first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Cytarabine
Injection affects you.
Drinking alcohol
No information is available.
Looking after your medicine
Cytarabine Injection is stored in the pharmacy or on the hospital ward under the correct
conditions.
Disposal of Cytarabine Injection
The hospital staff will correctly dispose of any Cytarabine Injection.
6. Are there any side effects?
All medicines can have side effects. Some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
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Side effects
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What to do
|
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hot, tender and red skin at the injection site
sore mouth, mouth ulceration
anal ulcer, anal inflammation
diarrhoea, vomiting, nausea, constipation
tiredness, sleepiness
loss of appetite
aching muscles, bone pain
hair loss or thinning
itching, rash, skin ulceration, peeling of the skin
abdominal pain
painful, swollen joints
redness, swelling, burning, tender skin with thick calluses or blisters on the palms
of your hands or soles of your feet
freckling
generally feeling unwell
|
Speak to your doctor or nurse if you have any of these side effects and they worry
you.
|
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sore throat
fever
infection
pale or yellowish skin, yellow eyes
irregular heartbeat, rapid heart rate
headache
sweating, chills,
shivering
dizziness or light-headedness
confusion, change in mental status or personality
coordination, movement and balance problems
numbness or loss of sensation
trouble sleeping
slurred speech
problems with vision
conjunctivitis or any pain or discomfort in the eyes
bluish skin, lips or nails
red, hard area under the skin near the injection site
swelling and skin colour changes in hands and feet
severe upper or lower stomach pain
difficulty passing urine (wee)
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Speak to your doctor or nurse as soon as possible if you notice any of these side
effects.
|
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signs of an allergic reaction such as shortness of breath, wheezing or difficulty
breathing; flushing; swelling of the face, lips, tongue or other parts of the body;
rash, itching or hives on the skin; dizziness or light-headedness
loss of feeling or movement
any unusual bruising or bleeding including bleeding from your rectum (bottom) or vomiting
that looks tarry or like ground coffee
cough with yellow, green or bloody mucus
shortness of breath, fast/ shallow breathing, wheezing
chest pain
coma
convulsion
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example certain liver conditions, and blood abnormalities)
can only be found when your doctor does tests from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Cytarabine Injection contains
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Active ingredient
(main ingredient)
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Cytarabine
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Other ingredients
(inactive ingredients)
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Hydrochloric acid
Sodium hydroxide
Water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
Each Cytarabine Injection contains cytarabine 20 mg per 1 mL.
What Cytarabine Injection looks like
Cytarabine Injection is a clear, colourless sterile solution in a vial.
Aust R 11351
Who distributes Cytarabine Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in December 2025.