Azacitidine Kabi is used for the treatment of adults with the following diseases if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells): - myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells and not enough healthy ones. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Kabi is used in patients with an intermediate to high risk of progressing to AML or death; - chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine Kabi is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells; - AML that has developed from a myelodysplastic syndrome, where the bone marrow consists of 20 to 30% abnormal cells; - AML, where the bone marrow has more than 30% abnormal cells. Azacitidine Kabi is a ‘generic medicine’. This means that Azacitidine Kabi contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Azacitidine Kabi is Vidaza. Azacitidine Kabi contains the active substance azacitidine.
Therapeutic Indication
### Therapeutic indication Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT) with: - Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the international prognostic scoring system (IPSS), - Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, - Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, - AML with > 30% marrow blasts according to the WHO classification.
Therapeutic Area (MeSH)
N/AATC Code
L01BC07
ATC Item
azacitidine
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| azacitidine | N/A | 阿扎胞苷 |
EMA Name
Azacitidine Kabi
Medicine Name
Azacitidine Kabi
Aliases
N/ANo risk management plan link.