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 given VIDAZA
VIDAZA contains the active ingredient azacitidine. VIDAZA is used to treat 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 cells.
2. What should I know before I am given VIDAZA?
Do not use if you have ever had an allergic reaction to azacitidine 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.
3. What if I am taking other medicines?
Some medicines may interfere with VIDAZA and affect how it works.
4. How am I given VIDAZA
VIDAZA will be given to you in hospital or clinic under the supervision of an experienced
doctor
5. What should I know while receiving VIDAZA
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Things you should do
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Remind any doctor, dentist, pharmacist or nurses you visit that you are using VIDAZA.
Tell your doctor immediately if you stop passing urine or if you are passing less
urine than normal.
If you become pregnant while taking this medicine, tell your doctor immediately.
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Driving or using machines
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Be careful driving or operating machinery until you know how VIDAZA affects you.
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6. Are there any side effects?
Like all medicines, VIDAZA can have side effects, although not everybody gets them.
Sometimes they may be serious, most of the time they are not. You may need medical
attention if you get some of the side effects
Active ingredient(s): azacitidine (ay″ za sye′ ti deen)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VIDAZA. 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 VIDAZA.
Where to find information in this leaflet:
1. Why am I given VIDAZA?
VIDAZA contains the active ingredient azacitidine. VIDAZA is an anti-cancer agent. VIDAZA contains a medicine called azacitidine which
prevents the growth of cancer cells.
VIDAZA 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 cells. 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 VIDAZA works, or why this medicine
has been prescribed for you.
VIDAZA will only be prescribed to you by a doctor who has experience in medicines
to treat cancers of the blood.
2. What should I know before I am given VIDAZA?
Warnings
Do not use VIDAZA if:
you are allergic to azacitidine or any of the ingredients of VIDAZA 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
you have advanced liver cancer
you are pregnant
you have severe problems with your kidney function
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
have had heart problems or lung disease
take any medicines for any other condition
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
Check with your doctor if you are pregnant or intend to become pregnant.
Avoid becoming pregnant while receiving VIDAZA but if you do, tell your doctor immediately.
Use an effective method of contraception during treatment with VIDAZA and for up to
six (6) months after discontinuation of VIDAZA.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breast-feed while you are receiving VIDAZA but if you do, tell your doctor
immediately. It is not known if VIDAZA is excreted in human milk.
1. Use by men
Do not father a child while receiving treatment with VIDAZA. Use barrier methods of contraception (e.g. condoms) during treatment and for up to
three (3) months after discontinuation of VIDAZA, if your partner is of childbearing
potential. Talk to your doctor if you wish to conserve your sperm before having this
treatment.
2. Use by all patients
Tell your doctor if you have any allergies to any other medicines, foods, preservatives,
or dyes.
Do not give VIDAZA to children (under 18 years).
You will have blood tests before you begin treatment with VIDAZA 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
other tests.
VIDAZA can cause a serious immune reaction called ‘differentiation syndrome’ (see
section 6 on Side Effects').
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines or have recently
taken any other medicines, including any medicines, vitamins, or supplements that
you buy without a prescription from your pharmacy, supermarket, or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
VIDAZA.
4. How am I given VIDAZA?
How is VIDAZA given
VIDAZA 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 VIDAZA for you.
How much VIDAZA you will be given
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 VIDAZA per metre squared of body surface area.
Initially, VIDAZA will be given daily for 7 days. 21 days later, you will have VIDAZA
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.
VIDAZA 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
VIDAZA.
If you have any further questions on the use of VIDAZA, ask your doctor or pharmacist.
If you miss a dose of VIDAZA
It is very important for you to keep all appointments to receive VIDAZA. If you miss
an appointment, ask your doctor when to schedule your next dose.
If you use too much VIDAZA
As VIDAZA is given to you under the supervision of your doctor, it is unlikely that
you will be given too much. However, if you experience any side effects after being
given VIDAZA, tell your doctor immediately.
5. What should I know while receiving VIDAZA?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being treated with VIDAZA.
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.
Call your doctor straight away if you:
stop passing urine or if you are passing less urine than normal.
become pregnant while taking this medicine.
Remind any doctor, dentist, or pharmacist you visit that you are using VIDAZA.
Driving or using machines
Be careful before driving or operating machinery until you know how VIDAZA affects
you.
Looking after your medicine
Your doctor or pharmacist is responsible for storing VIDAZA. They are also responsible
for disposing of any unused VIDAZA correctly.
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.
Serious side effects
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Serious side effects
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What to do
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Allergic reaction
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
Bleeding in the brain (a type of stroke)
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.
Pneumonia (a serious lung infection)
Fever; chills; shortness of breath; cough; phlegm; or occasionally coughing up blood.
Sepsis (blood infection) or other frequent infections
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.
Bleeding in your gut
Vomiting blood or material that looks like coffee grounds; bleeding from the back
passage; black sticky bowel motions (stools); or bloody diarrhoea.
Serious immune reaction (differentiation syndrome)
Fever; cough, difficulty breathing, rash, decreased urine, low blood pressure (hypotension),
swelling of the arms or legs and rapid weight gain.
Bleeding (including nose-bleeds) or bruising in the absence of injury, or you are
more tired than usual.
Cutaneous vasculitis
Inflammation of blood vessels in the skin which may result in rash.
VIDAZA 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.
Bleeding in eyes
Pain in one or both eyes, changes in vision.
Blood in the urine.
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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 serious side effects.
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Other side effects
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Very common side effects
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What to do
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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 feeling confused.
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.
Chest pain.
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Speak to your doctor if you have any of these side effects and they worry you.
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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, high blood pressure) 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 affects 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 VIDAZA contains
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Active ingredient
(main ingredient)
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azacitidine
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Other ingredients
(inactive ingredients)
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mannitol
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Do not take this medicine if you are allergic to any of these ingredients.
What VIDAZA looks like
VIDAZA is a white powder for suspension for injection and is supplied in a glass vial
containing 100 mg of azacitidine.
(Aust R 153080).
Who distributes VIDAZA
VIDAZA is supplied in Australia by:
Celgene Pty Ltd.
Level 2, 4 Nexus Court
Mulgrave VIC 3170
Australia.
Telephone: 1800 CELGENE
(1800 235 4363)
® = Registered Trademark
VIDAZA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
This leaflet was prepared in January 2024