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 using Onureg?
Onureg contains the active ingredient azacitidine. Onureg is used to treat adults
with a certain type of leukaemia called acute myeloid leukaemia (AML). For more information,
see Section
1. Why am I using Onureg? in the full CMI.
2. What should I know before I use Onureg?
Do not take this medicine if you are allergic to the active ingredient in Onureg (azacitidine)
or any of the ingredients listed at the end of the CMI.
Do not use Onureg if you plan to become pregnant, are pregnant or breastfeeding.
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.
For more information, see Section
2. What should I know before I use Onureg? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Onureg and affect how it works. Onureg may also
affect the way some other medicines work.
A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How do I use Onureg?
Onureg tablets should be taken exactly as your doctor has told you. Check with your
doctor if you are not sure about how much you should take or how often you should
take this medicine. More instructions can be found in Section
4. How do I use Onureg? in the full CMI.
5. What should I know while using Onureg?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Onureg.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to
become pregnant.
Tell your doctor, pharmacist or nurse straight away if you get any of these symptoms
during treatment with Onureg: bruising or bleeding - this could be due to a low count
of blood cells called “platelets”; fever - this could be due to an infection as a
result of having low levels of white blood cells - which can be life-threatening;
diarrhoea; being sick or a feeling of sickness.
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Things you should not do
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Do not use if you have ever had an allergic reaction to Onureg or any of the ingredients
listed at the end of the CMI. Do not breast feed whilst taking Onureg. Do not use
this medicine during pregnancy as it may be harmful to your baby.
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Driving or using machines
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This medicine may cause tiredness, weakness or trouble concentrating. If you have
any of these symptoms or other side effects, do not drive, operate machinery or do
anything else that could be dangerous.
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Looking after your medicine
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Store the tablets in the original package.
Store below 25°C.
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6. Are there any side effects?
Like all medicines, Onureg can have side effects, although not everybody gets them,
and some are uncommon. Sometimes they are serious, most of the time they are not.
You may need medical attention if you get some of the side effects. If you experience
bruising or bleeding; fever; diarrhoea, being sick or have a feeling of sickness.
contact your doctor immediately, or go to the Emergency Department at your nearest
hospital. 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(s): azacitidine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Onureg. 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 Onureg.
Where to find information in this leaflet:
1. Why am I using Onureg?
Onureg contains the active ingredient azacitidine.
Azacitidine works by preventing cancer cells from growing. Azacitidine gets into the genetic
material of cells (called RNA and DNA). It works by altering the way the cell turns
genes on and off. It also reduces the production of new RNA and DNA. This is thought
to kill cancer cells in leukaemia.
Onureg is used to treat adults with a certain type of leukaemia called acute myeloid
leukaemia (AML). This is a form of cancer which affects your bone marrow and can cause
problems with producing normal blood cells. Onureg is used to maintain remission of
the illness, the time when the disease is less severe or not active.
2. What should I know before I use Onureg?
Your doctor will conduct a blood test prior to starting you on Onureg and during treatment.
This is to check that you have enough blood cells. It is also to check that your liver
and kidneys are working properly. Your doctor will decide how often you have blood
tests.
Warnings
Do not use Onureg if:
you are allergic to azacitidine, or any of the ingredients of this medicine.
you are breastfeeding.
you are pregnant or think you may be pregnant.
Always check the ingredients and speak to your doctor to make sure you can use this
medicine.
Check with your doctor if you:
are pregnant, think you may be pregnant or are planning to become pregnant. Onureg
may cause harm to your unborn baby if taken during pregnancy. Your doctor will arrange
a pregnancy test before treatment.
are breastfeeding or planning to breast feed
are a woman, Onureg may cause fertility problems, which may affect your ability to
have a baby. Talk to your doctor for advice before taking Onureg.
are a man, and are planning to father a child. Men should not father a child while
receiving treatment with Onureg.
are taking, have recently taken or might take any other medicines for any other condition
are intolerant to lactose. If you have been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking this medicine.
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
Do not take Onureg during pregnancy as it may be harmful to your baby.
Do not breast-feed while taking Onureg. It is not known if this medicine passes into
human milk.
If you are pregnant, breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
You or your partner must use an effective method of contraception during treatment
and for 6 months after stopping Onureg. Talk to your doctor about contraceptive methods
that may be right for you while you are taking Onureg.
Tell your doctor straight away if you become pregnant during treatment.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Fertility information for men
Men should not father a child while receiving treatment with Onureg.
Use an effective method of contraception during treatment and for 3 months after stopping
Onureg.
Use in children or adolescents
This medicine is not recommended for use in children and adolescents under 18 years.
Onureg contains lactose
Onureg contains lactose. If you have been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking this medicine.
Onureg contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that
is to say essentially ‘sodium-free’.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Onureg.
4. How do I use Onureg?
How much to take
The recommended dose is 300 mg taken by mouth once daily. Your doctor may reduce your
dose to 200 mg once daily, if needed.
Onureg is given in treatment cycles of 28 days.
You take Onureg every day for the first 14 days of each 28 day cycle. This is followed
by a treatment free period of 14 days for the rest of the cycle.
Your doctor will tell you what dose of Onureg to take. The doctor may decide to:
extend your treatment beyond 14 days in each treatment cycle
lower your dose or temporarily stop treatment
reduce your treatment to 7 days.
Always take as prescribed by your doctor.
Your doctor will give you another medicine to reduce the risk of feeling sick (nausea)
and being sick (vomiting). You will take it 30 minutes before each Onureg tablet,
during your first and second treatment cycles. Your doctor will tell you to take it
for a longer period, if you need it.
When to take Onureg
Take Onureg once a day - at the same time each day.
If you are sick after taking a tablet, do not take another dose on the same day. Instead,
wait till the next day and take your next scheduled dose then. Do not take two doses
on the same day.
How to take Onureg
Swallow the Onureg tablets whole with a full glass of water. To make sure you get
the right dose, do not break, crush, dissolve or chew the tablets.
Onureg tablets can be taken with or without food.
Always take as prescribed by your doctor.
If powder from a broken tablet gets onto your skin, wash the skin straight away and
thoroughly with soap and water. If the powder gets into your eyes, nose or mouth,
flush thoroughly the area with water.
If you forget to use Onureg
If you forget to take Onureg at the usual time, take your usual dose as soon as you
remember on the same day and take your next dose at the usual time on the following
day.
Do not take a double dose to make up for a forgotten or vomited tablet.
Do not stop taking Onureg unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor.
If you use too much Onureg
If you think that you have used too much Onureg, you may need urgent medical attention.
If possible, take the medicine pack and this leaflet with you.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Onureg?
Things you should do
Keep all of your doctor’s appointments so that your progress can be checked.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being treated with Onureg.
Tell your doctor immediately if you become pregnant while being treated with Onureg
Advice for women: use an effective method of contraception during treatment and for
6 months after stopping Onureg.
Advice for men: Use an effective method of contraception during treatment and for
3 months after stopping Onureg.
Call your doctor straight away or go to the Emergency Department at your nearest hospital
if you:
experience 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 a serious allergic reaction.
Things you should not do
Do not breast feed if you are taking Onureg.
Do not use this medicine during pregnancy.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Onureg
affects you.
Onureg may cause tiredness, dizziness or feeling faint in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Looking after your medicine
Store the tablets in the original package.
Store below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Do not use this medicine after the expiry date which is stated on the blister and
the carton after EXP. The expiry date refers to the last day of that month.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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.
Other 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 side effects (for example changes in 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 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 Onureg contains
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Active ingredient
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azacitidine
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Other ingredients
(inactive ingredients)
Onureg 200mg Tablet Coating
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croscarmellose sodium, hypromellose, iron oxide red, lactose monohydrate, polyethylene
glycol/macrogol, magnesium stearate, mannitol, silicified microcrystalline cellulose,
titanium dioxide, triacetin
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Other ingredients
(inactive ingredients)
Onureg 300mg Tablet Coating
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black iron oxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide
yellow, lactose monohydrate, polyethylene glycol/macrogol, magnesium stearate, mannitol,
silicified microcrystalline cellulose, titanium dioxide, triacetin
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Potential allergens
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Lactose Monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What Onureg looks like
Onureg 200 mg film-coated tablets are pink and oval shaped with “200” imprinted on
one side and “ONU” on the other side (Aust R 370367).
Onureg 300 mg film-coated tablets are brown and oval shaped with “300” imprinted on
one side and “ONU” on the other side (Aust R 370372).
Who distributes Onureg in Australia
Celgene Pty Limited
Level 2/4 Nexus Court
Mulgrave VIC 3170
Telephone: 1800 CELGENE (1800 235 4363).
ONUREG® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
This leaflet was prepared in February 2023.