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Acute Myeloid Leukaemia Clinical criteria: The treatment must be used in combination with venetoclax (refer to Product Information for timing of azacitidine and venetoclax doses).
Myelodysplastic syndrome Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must not have progressive disease. Up to 6 cycles will be authorised.
Chronic Myelomonocytic Leukaemia Clinical criteria: Treatment Phase: Initial treatment The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report, AND The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder. The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following reports must be documented in the patient's medical records: (a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) full blood examination report No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
“Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal haematopoietic cells in the bone marrow.”
“Azacitidine disappeared from plasma rapidly with a mean half-life after SC administration of 41 ± 8 minutes.”
“Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs).”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.