Consumer medicine information

1. Why am I using Azacitidine SXP?

AZACITIDINE SXP contains the active ingredient azacitidine. AZACITIDINE SXP is used 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.
For more information, see Section 1. Why am I being given AZACITIDINE SXP? in the full CMI.

2. What should I know before I am given Azacitidine SXP?

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 SXP? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AZACITIDINE SXP and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given Azacitidine SXP?

AZACITIDINE SXP is an injection and will be given to you by your doctor or nurse.
More instructions can be found in Section 4. How will I be given AZACITIDINE SXP? in the full CMI.

5. What should I know while being given Azacitidine SXP?

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.
Some of the common and serious side effects are included in full below in the CMI. Speak to your doctor if you have any of these common or serious side effects and they worry you.
The very serious side effects are:

• 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.

• 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.

• Fever; chills; shortness of breath; cough; phlegm; or occasionally coughing up blood.

• 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.

• Vomiting blood or material that looks like coffee grounds; bleeding from the back passage; black sticky bowel motions (stools); or bloody diarrhoea.

Notes

Distributed by Southern XP Pty Ltd

1 Name of Medicine

Azacitidine.

2 Qualitative and Quantitative Composition

Each vial contains 100 mg azacitidine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Azacitidine SXP is a white to off-white, sterile lyophilised powder.

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

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.
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/AZASXPST.gif