Fresenius Kabi announced the launch of Arsenic Trioxide Injection 10mg/10mL, a generic version of Teva‘s Trisenox

Arsenic Trioxide, an arsenical, is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 

Arsenic Trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. It also causes damage or degradation of the fusion protein promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha. 

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The labeling carries a Boxed Warning describing the risk of differentiation syndrome and cardiac conduction abnormalities. 

Arsenic Trioxide Injection is supplied in 10mL single-dose vials; it is indicated for intravenous (IV) administration.

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