Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being given ZAVEDOS?
ZAVEDOS contains the active ingredient idarubicin hydrochloride. ZAVEDOS is used to
treat a type of leukemia in adults known as AML (acute myelogenous leukaemia).
2. What should I know before I am given ZAVEDOS?
You will not be given ZAVEDOS if you have ever had an allergic reaction to idarubicin
hydrochloride, other similar medicines for cancer or any of the ingredients listed
at the end of the CMI.
Talk to your doctor if you have any other medical conditions especially problems with
your heart, take any other medicines, or are pregnant or unsure if you are pregnant
or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ZAVEDOS and affect how it works.
4. How is ZAVEDOS given?
ZAVEDOS is injected slowly into a vein. It must only be given by a doctor or nurse.
Your doctor will decide what dose, how often, and how long you will receive it.
5. What should I know while being given ZAVEDOS?
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Things you should do
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Remind any doctor, dentist, nurse or pharmacist you visit that you are being given
ZAVEDOS.
Tell your doctor immediately if you or your partner becomes pregnant while you are
taking or just after you stop taking ZAVEDOS.
You and your partner should use a proven method of birth control during treatment
with ZAVEDOS. Proven birth control must continue to be used for at least 6 and a half
months after the last dose for women and 3 and a half months after the last dose for
men.
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Things you should not do
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You should not be given this medicine if you are pregnant or you or your partner are
planning to become pregnant.
Do not breastfeed during treatment with ZAVEDOS and for at least 14 days after last
dose.
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Driving or using machines
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Be careful driving or operating machinery until you know how this medicine affects
you. If you are feeling dizzy or drowsy do not drive, operate machinery, or do anything
else that could be dangerous.
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6. Are there any side effects?
Side effects may include: red-coloured urine for 1-2 days after treatment, nausea,
vomiting, diarrhoea, loss of appetite, stomach pain & discomfort, mouth ulcers, redness
& irritation of the throat & mouth with difficulty in swallowing & eating, skin changes,
loss of hair, hot flushes, allergic reactions; skin rash; itching; redness of the
skin or hives; signs of infection; signs of anaemia, bleeding or bruising more easily
than normal; shock due to a dangerous drop in blood pressure which may lead to collapse
& coma; signs of sepsis or blood poisoning; chest pain; abnormal heartbeat; fast heartbeat;
shortness of breath; swelling in the feet or legs due to fluid build-up; vomiting
blood or bleeding from the back passage; black sticky bowel motions or bloody diarrhoea;
swelling and redness along a vein which is extremely tender when touched.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
idarubicin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ZAVEDOS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ZAVEDOS.
Where to find information in this leaflet:
1. Why am I being given ZAVEDOS?
ZAVEDOS contains the active ingredient idarubicin hydrochloride.
ZAVEDOS is used to treat a type of leukaemia in adults known as AML (acute myelogenous
leukaemia). It works by stopping cancer cells from growing and multiplying. It may be used alone
or in combination with other chemotherapy.
Your doctor may have prescribed ZAVEDOS for another reason.
Ask your doctor if you have any questions about why ZAVEDOS has been prescribed for
you.
There is no evidence that ZAVEDOS is addictive.
ZAVEDOS is only available with a doctor's prescription.
2. What should I know before I am given ZAVEDOS?
Warnings
You should not be given ZAVEDOS if:
you are allergic to idarubicin hydrochloride, or any of the ingredients listed at
the end of this leaflet.
you are allergic to any other similar medicines for cancer, e.g., daunorubicin, doxorubicin,
epirubicin, mitoxantrone
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
you have severe kidney problems
you have severe liver problems
you have severe heart problems including heart failure, abnormal heartbeat or a recent
heart attack
you have a severe infection, with signs such as fever, severe chills, sore throat
or mouth ulcers
you have a reduced number of red or white blood cells or platelets
you have previously received the full course of treatment with the maximum dose of
idarubicin or other similar medicines e.g., daunorubicin, doxorubicin, epirubicin,
mitozantrone/mitoxantrone
you are pregnant or trying to become pregnant.
Tell your doctor if you have or have had any medical conditions, especially the following:
kidney disease
liver disease
heart disease
previous treatment with ZAVEDOS or any other chemotherapy
previous radiation therapy
anaemia
bone marrow transplant
bone marrow depression, a blood disorder with low platelet, red blood and white blood
cell counts
infection or high temperature, severe chills, sore throat or mouth ulcers
stomach ulcers, or vomiting blood or bleeding from the back passage.
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 and breastfeeding
You should not be given ZAVEDOS if you are pregnant or intend to become pregnant or
your partner is trying to become pregnant.
This medicine may cause birth defects if you or your partner is being treated with
it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Women should not breastfeed during treatment with ZAVEDOS and for at least 14 days
after the last dose.
Consult your doctor or midwife if you have any concerns about being unable to breastfeed
for this period.
Contraception
Talk to your doctor about an effective contraceptive method and fertility preservation
before starting your treatment with ZAVEDOS.
Women of childbearing potential should use effective contraception during treatment
with ZAVEDOS and for at least 6.5 months after the final dose. Men with female partners
of childbearing potential must use an effective contraception during treatment and
for at least 3.5 months after the final dose. If planning for conception, it is advisable
to seek genetic counselling.
3. What if I am taking other medicines?
Tell your doctor 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 ZAVEDOS and affect how it works. These include:
other medicines for cancer
some medicines for heart problems, including calcium channel blockers, used to treat
high blood pressure and angina
certain medicines that may affect your liver and kidney function, e.g. some antibiotics
and antifungals
vaccines.
These medicines may increase some side effects of ZAVEDOS including the effects on
the heart, blood cells, the stomach or bowels, and reduce the body's ability to fight
infection.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZAVEDOS.
4. How is ZAVEDOS given?
How much and how long is it given
ZAVEDOS is given in a clinical setting by a nurse or doctor.
Your doctor will decide what dose, how often and how long you will receive it. This
depends on your condition and other factors, such as your weight.
How ZAVEDOS is given
ZAVEDOS is injected slowly into a vein.
If too much ZAVEDOS is given
Since ZAVEDOS is given in a hospital or clinic under the supervision of a doctor,
it is very unlikely that you will be given too much of the medicine. Your doctor or
nurse will be monitoring your progress and checking the medicine that you are given.
If you think that you may have been given too much ZAVEDOS, you may need urgent medical
attention.
5. What should I know while being given ZAVEDOS?
Things you should do
Keep all appointments with your doctor so that your progress can be checked.
You will have regular tests to monitor your blood count, kidney and liver function,
and your heart before, during and after treatment.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you
are taking this medicine.
Call your doctor straight away if you:
or your partner becomes pregnant while you are taking or just after you stop taking
ZAVEDOS
develop redness or swelling at the injection site.
Things to be careful of
Take the following precautions to reduce your risk of infection or bleeding:
Avoid people who have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain or find it painful or difficult to urinate
Be careful when using a toothbrush, toothpick, or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutters
Avoid contact sports or other situations where you may bruise or get injured.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZAVEDOS
affects you.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, 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.
Side effects
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Side effects
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What to do
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Renal disorders
red coloured urine for 1-2 days after treatment (this is normal and is no cause for
alarm).
Gastrointestinal disorders
nausea and vomiting
diarrhoea
loss of appetite
stomach pain and discomfort
Skin and subcutaneous tissue disorders
mouth ulcers
skin changes such as darker areas of the skin and nails
loss of hair
Vascular disorders
hot flushes
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Speak to your doctor if you have any of these side effects and they worry you.
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More serious side effects
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More serious side effects
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What to do
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Cardiac disorders
chest pain
abnormal heartbeat
fast heartbeat
shock due to dangerous drop in blood pressure which may lead to collapse and coma
- signs include rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse,
dizziness, weakness and fainting.
Skin and subcutaneous tissue disorders
allergic reactions (swelling of the face, lips and tongue or other parts of the body,
shortness of breath, wheezing or trouble breathing)
skin rash, itching, redness of the skin or hives
bleeding or bruising more easily than normal
swelling and redness along a vein which is extremely tender when touched
clotting in a vein
swelling in the feet or legs due to fluid build-up.
General disorders and administrative site conditions
signs of infection such as fever, chills, cough or mouth ulcers
signs of sepsis or blood poisoning such as high fever, chills, headache, confusion,
rapid breathing
Blood and lymphatic system disorders
signs of anaemia such as headaches, shortness of breath, when exercising, dizziness,
looking pale
Gastrointestinal disorders
vomiting blood
bleeding from the back passage
black sticky bowel motions (stools)
bloody diarrhoea
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these more serious side effects.
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Some side effects (for example, an increase in liver enzyme levels) can only be found
when your doctor does tests from time to time to check your progress.
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.
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 ZAVEDOS contains
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Active ingredient
(main ingredient)
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idarubicin hydrochloride
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Other ingredients
(inactive ingredients)
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glycerol
hydrochloric acid
water
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Do not take this medicine if you are allergic to any of these ingredients.
ZAVEDOS does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
What ZAVEDOS looks like
ZAVEDOS is a red-orange coloured solution contained in a plastic or a glass vial.
Australian Registration Numbers
ZAVEDOS idarubicin hydrochloride 5mg/5mL injection vial - ARTG R 67397
ZAVEDOS idarubicin hydrochloride 10mg/10mL injection vial - ARTG R 67398
Who distributes ZAVEDOS
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in July 2025.
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