1 mg/ml
Trade Name
Arsenic trioxide
Concentrate for solution for infusion
Request Type
Registration
Drug Type
Generic Drug
Approval Date
SFDA Approved Use
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103 /µl) in combination with all-trans-retinoic acid (ATRA)
• Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103 /µl) in combination with all-trans-retinoic acid (ATRA)
• Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.