Consumer medicine information

Onureg 200 mg Tablets

Azacitidine

BRAND INFORMATION

Brand name

Onureg

Active ingredient

Azacitidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Onureg 200 mg Tablets.

1. Why am I given 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 given 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?

Things you should do
  • 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.
Things you should not do
  • 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.
Driving or using machines
  • 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.
Looking after your medicine
  • Store the tablets in the original package.
  • Store below 25°C.

For more information, see Section 5. What should I know while using Onureg? in the full CMI.

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.

BRAND INFORMATION

Brand name

Onureg

Active ingredient

Azacitidine

Schedule

S4

 

1 Name of Medicine

Azacitidine.

2 Qualitative and Quantitative Composition

Each 300 mg film-coated tablet contains 300 mg azacitidine.
Each 200 mg film-coated tablet contains 200 mg azacitidine.
Excipient with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oral azacitidine is available as the following formulations:
200 mg film-coated tablet. Pink, oval tablet with debossed "200" on one side and "ONU" on the other side.
300 mg film-coated tablet. Brown, oval tablet with debossed "300" on one side and "ONU" on the other side.

4 Clinical Particulars

4.9 Overdose

In the event of overdose, monitor the patient with appropriate blood counts and provide supportive treatment, as necessary, according to local recommendations. There is no known specific antidote for azacitidine overdose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Azacitidine was mutagenic, as assessed in Salmonella typhimurium, Escherichia coli, L5178Y mouse lymphoma cells and human lymphoblast TK6 cells. Azacitidine was clastogenic in the in vitro micronucleus assays in Syrian hamster embryo fibroblasts and L5178Y mouse lymphoma cells. Azacitidine induced morphological transformation in Syrian hamster kidney and embryo fibroblasts. No in vivo tests have been conducted with azacitidine.
Carcinogenicity. Azacitidine has been shown to be carcinogenic when administered by the intraperitoneal route 2 or 3 times weekly for 50-52 weeks in mice at doses of 6 or 6.6 mg/m2 and for 8-36 weeks in rats at doses of 15 or 60 mg/m2. These doses are well below the recommended human daily dose (when compared on a mg/m2 basis). Tumour types included lung, testicular, mammary gland, and skin tumours, lymphomas and tumours of the haematopoietic system.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAZACIT.gif CAS number. 320-67-2.
Molecular formula: C8H12N4O5. Molecular weight: 244 g/mol.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ONUREGST.gif