Powder for Injection
(azacitidine 100 mg)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Azacitidine-Teva.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Azacitidine-Teva against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Azacitidine-Teva is used for
Azacitidine-Teva is an anti-cancer agent.
Azacitidine-Teva contains a medicine called azacitidine which prevents the growth
of cancer cells. Azacitidine-Teva has been prescribed by your doctor for the treatment
of myelodysplastic syndrome (MDS). Myelodysplastic syndrome is a blood disorder in
which the bone marrow is not working normally and does not produce enough mature blood
This causes a lack of healthy blood cells that can function properly in the body.
Ask your doctor if you have any questions about how Azacitidine-Teva works or why
this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Azacitidine-Teva will only be prescribed to you by a doctor who has experience in
medicines to treat cancers of the blood.
Before you are given Azacitidine-Teva
When you must not be given Azacitidine-Teva
Tell your doctor
If you are allergic to azacitidine or any of the other ingredients of Azacitidine-Teva
listed at the end of this leaflet.
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.
If you have advanced liver cancer
If you are pregnant
If you have severe problems with your kidney function
Before you are given Azacitidine-Teva
Avoid becoming pregnant while receiving Azacitidine-Teva but if you do, tell. your
Use an effective method of contraception during treatment with Azacitidine-Teva and
for up to three (3) months after discontinuation of Azacitidine-Teva.
Do not breast-feed while you are receiving Azacitidine-Teva but if you do, tell your
It is not known if Azacitidine-Teva is excreted in human milk.
Do not father a child while receiving treatment with Azacitidine-Teva.
Use barrier methods of contraception (e.g. condoms) during treatment and for up to
three (3) months after discontinuation of Azacitidine-Teva, if your partner is of
Talk to your doctor if you wish to conserve your sperm before having this treatment.
Tell your doctor if you have any allergies to any other medicines, foods, preservatives
Do not give Azacitidine-Teva to children (under 18 years).
Before receiving Azacitidine-Teva, tell your doctor if you have had any heart problems
or lung disease.
You will have blood tests before you begin treatment with Azacitidine-Teva and at
the start of each period of treatment (called a 'cycle'). This is to check that you
have enough blood cells and that your liver and kidneys are working properly.
If you are older than 65 years, your doctor will give you the regular blood tests
described above but may also check your kidney function during your treatment with
Taking other medicines
Tell your doctor if you are taking any other medicines or have recently taken any
other medicines, including any medicines that you buy without a prescription from
a pharmacy, supermarket or health food shop.
How you will be given Azacitidine-Teva
Azacitidine-Teva will be given to you as an injection under the skin (subcutaneously
i.e. under the skin on your thigh, abdomen or upper arm) or as an intravenous infusion
by a doctor or a nurse.
Your doctor will choose the correct dose of Azacitidine-Teva for you.
Your dose will depend on your general condition and your height and weight.
Your dose will be calculated based on your body surface area, with the usual dose
of 75 mg Azacitidine-Teva per metre squared of body surface area.
Initially, Azacitidine-Teva will be given daily for 7 days. 21 days later, you will
have Azacitidine-Teva for another 7 days. This is called a 'cycle'. The cycle is repeated
every 28 days for a minimum of 6 cycles.
Your doctor will check your progress and may change your dose if necessary.
Azacitidine-Teva can cause nausea and vomiting. To stop you from getting sick (nausea
and vomiting), your doctor may give you another medicine at the start of each treatment
cycle with Azacitidine-Teva.
If you have any further questions on the use of Azacitidine-Teva, ask your doctor
While you are being treated with Azacitidine-Teva
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being treated with Azacitidine-Teva.
Tell your doctor immediately if you stop passing urine or if you are passing less
urine than normal.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being treated with this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor will do some tests e.g. blood tests, at regular intervals to make sure
the medicine is working and to prevent any unwanted side effects.
Things to be careful of
Be careful driving or operating machinery until you know how Azacitidine-Teva affects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are receiving Azacitidine-Teva.
Like all medicines, Azacitidine-Teva can have side effects, although not everybody
gets them. Sometimes they are serious, most of the time they are not.
You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
Tell your doctor or pharmacist if you notice any of the following and they worry you.
Sore throat or trouble swallowing; feeling of tension in the nose, cheeks or behind
your eyes; runny or blocked nose.
Trouble sleeping; feeling tired or lacking energy; dizziness; headache; anxiety; or
Loss of appetite, decreased weight, constipation, stomach pain, indigestion.
Cold sores or bleeding from the gums.
Red or purple, flat, pinhead spots under the skin; itching; rash; bruising, redness
of the skin; soreness and swelling at the injection site; unusual hair loss or thinning.
Muscle or joint pain.
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
Bleeding (including nosebleeds) or bruising in the absence of injury, or you are more
tired than usual.
Azacitidine-Teva can reduce the number of red blood cells that carry oxygen around
the body and can also reduce the number of platelets, which are responsible for making
the blood clot appropriately
Pain in one or both eyes, changes in vision.
This could be due to bleeding in your eyes.
Blood in the urine.
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
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.
These could be symptoms of an allergic reaction.
A sudden severe headache; weakness or numbness in the face, arm or leg; changes in
vision; trouble speaking or understanding speech; or loss of coordination.
These could be signs of bleeding in the brain (a type of stroke).
Fever; chills; shortness of breath; cough; phlegm; or occasionally coughing up blood.
These could be symptoms of pneumonia (a serious lung infection).
Fever; severe chills; hot, tender and red skin; rapid breathing; rapid pulse; confusion;
nausea; vomiting; diarrhoea; pain or burning when you urinate; sore mouth or throat;
or mouth ulcers.
These could be symptoms of sepsis (blood infection) or other frequent infections.
Vomiting blood or material that looks like coffee grounds; bleeding from the back
passage; black sticky bowel motions (stools); or bloody diarrhoea.
These could be signs of bleeding in your gut.
The above list includes very serious side effects. You may need urgent medical attention
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects (for example, high blood pressure) can only be found when
your doctor does tests from time to time to check your progress.
After being given Azacitidine-Teva
Your doctor or pharmacist is responsible for storing Azacitidine-Teva. They are also
responsible for disposing of any unused Azacitidine-Teva correctly.
What Azacitidine-Teva looks like
Azacitidine-Teva is a white powder for suspension for injection and is supplied in
a glass vial containing 100 mg of azacitidine.
The active substance is azacitidine.
The other ingredients are sucrose, monobasic sodium phosphate monohydrate and dibasic
sodium phosphate dihydrate.
This medicine does not contain lactose.
Azacitidine-Teva is supplied in Australia by:
Teva Pharma Australia Pty Ltd
Macquarie Park NSW 2113
® = Registered Trademark
This leaflet was updated in July 2019.
Australian Registration Number: AUST R 299040