Consumer medicine information

1. Why am I given Azacitidine-Teva?

Azacitidine-Teva contains the active ingredient azacitidine. Azacitidine-Teva 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.
For more information, see Section 1. Why am I given Azacitidine-Teva? in the full CMI.

2. What should I know before I am given Azacitidine-Teva?

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.
For more information, see Section 2. What should I know before I am given Azacitidine-Teva? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Azacitidine-Teva and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given Azacitidine-Teva?

Azacitidine-Teva will be given to you in a hospital or clinic under the supervision of an experienced doctor.
More instructions can be found in Section 4. How am I given Azacitidine-Teva? in the full CMI.

5. What should I know while receiving Azacitidine-Teva?

6. Are there any side effects?

Like all medicines, Azacitidine-Teva 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.
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.

1 Name of Medicine

Azacitidine.

2 Qualitative and Quantitative Composition

Vials of Azacitidine-Teva contain 100 mg of azacitidine.
The azacitidine solution is adjusted to pH 7.0 ± 0.5.
List of excipients with known effect. Sucrose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Azacitidine is a white to off-white solid. It is insoluble in acetone, ethanol, and methyl ethyl ketone. Azacitidine is slightly soluble in ethanol/water (50/50) and propylene glycol; it is sparingly soluble in water (13.8 mg/mL), 5% glucose in water and in normal saline.
The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion.

4 Clinical Particulars

4.9 Overdose

In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for azacitidine overdosage. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
One case of overdose with azacitidine was reported during clinical trials. A patient experienced diarrhoea, nausea, and vomiting after receiving a single IV dose of approximately 290 mg/m², almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Azacitidine was mutagenic, as assessed in Salmonella typhimurium, 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 7-13 mg/m² and for 8-36 weeks in rats at doses of 16-60 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

The pH of azacitidine at the concentration of 0.12 mg/mL is 8.6. The partition coefficient LogP is -2.3 and the pKa is 2.4.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAZACIT.gif Molecular formula: C₈H₁₂N₄O₅.
Molecular weight: 244.2.
Chemical name: 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one.
CAS number. 320-67-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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