Powder for Suspension for Injection
(azacitidine 100mg)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
WHAT IS VIDAZA USED FOR
Vidaza contains a medicine called azacitidine which works by preventing 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 too few blood cells are produced.
Each pack of Vidaza contains 1 vial. Each vial contains 100mg azacitidine and 100mg of mannitol. The contents of the vial are mixed with 4mL of water before it is given to you as an injection.
BEFORE YOU TAKE VIDAZA
Vidaza will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood.
Follow all of your doctor's instructions carefully, even if they differ from the general information given in this leaflet.
Do not take Vidaza:
If you are allergic to Vidaza or any of the other ingredients of Vidaza listed at the end of this leaflet.
If you have advanced liver cancer.
If you are pregnant
If you have severe problems with your kidney function (creatinine clearance of less than 30 mLs/min)
If any of these apply to you, tell your doctor before you take Vidaza.
Your doctor will need to be aware if any of the following apply to you:
if you have a lower number of red or white blood cells than normal.
if you have a lower number of blood platelets than normal (thrombocytopenia).
if you have liver problems.
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.
Before receiving Vidaza tell your doctor if you have had any heart problems or lung disease.
Taking other medicines:
Please tell your doctor or pharmacist 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.
Children:
Vidaza is not to be taken by children (under 18 years).
Use by pregnant women:
Do not take Vidaza if you are pregnant. In addition, you should not become pregnant while taking Vidaza but, if you do, you should inform your doctor immediately.
Use an effective method of contraception during treatment with Vidaza.
Use by men:
Do not father a child while receiving treatment with Vidaza. You should use barrier methods of contraception (e.g. condoms) if your partner is of child-bearing potential.
Talk to your doctor if you wish to conserve your sperm before having this treatment.
Use by breast-feeding women:
It is not known if Vidaza is excreted in human milk. Therefore, do not breast-feed while you are receiving Vidaza but, if you do, you should inform your doctor immediately.
Use in other cases
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.
Driving and using machines:
If you experience side effects, such as dizziness, tiredness or blurred vision, take special care when driving or operating machines.
HOW TO TAKE VIDAZA
Vidaza will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse. It may be given under the skin on your thigh, abdomen or upper arm.
Your doctor will choose the correct dose of Vidaza for you.
Your dose will depend on your general condition and your height and weight.
The usual dose is 75 milligrams per metre squared.
Initially, Vidaza will be given daily for 7 days. 28 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.
To stop sickness (nausea and vomiting) from happening, 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.
WHILE YOU ARE TAKING VIDAZA
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Vidaza.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Vidaza.
If you become pregnant while taking Vidaza tell your doctor immediately.
SIDE EFFECTS
Like all medicines, Vidaza can have side effects, although not everybody gets them. You should tell your doctor straight away if you experience any of the following:
Constipation or diarrhoea.
Feeling sick or vomiting.
Chest pain.
Tiredness or lethargy.
A reaction where the injection was given including redness, pain or a skin reaction.
Changes to your skin at the injection site such as the formation of a hard lump, swelling, bleeding into your skin, rash, itching and changes in the skin colour.
Loss of appetite and weight loss.
Joint aches
Bruising
Pain in your stomach
Fever
Sore nose and throat
Headache, dizziness or confusion
Cold sores or bleeding gums.
Bleeding from around your back passage.
Blood in your urine.
Bleeding in your eye.
Ulcers of your mouth or tongue.
Allergic reaction.
High or low blood pressure
Being short of breath
Pain in your throat and voicebox
Indigestion
Feeling generally unwell
Muscle aches
Anxiety or having trouble sleeping
Hair loss
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
AFTER TAKING VIDAZA
How to store Vidaza
Your doctor or pharmacist are responsible for storing Vidaza. They are also responsible for disposing of any unused Vidaza correctly.
Do not use after the expiry date stated on the vial label and carton. The expiry date refers to the last day of the month.
Keep out of the reach and sight of children.
Store below 25°C.
PRODUCT DESCRIPTION
What does Vidaza look like
Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100mg of azacitidine.
What Vidaza contains
The active substance is azacitidine.
The other ingredient is mannitol.
Sponsor
Vidaza is supplied in Australia by:
Celgene Pty Ltd.
Level 7, 607 St Kilda Road,
Melbourne Vic 3004.
Telephone: 03 9539 5500
This leaflet was approved on 23 November 2009
Australian Registration Number: 153080
