Posted from: Monday, December 10, 2018 - 11:05 AM - Present

Trisenox 10mg/10mL Generic Launched

October 26, 2018 – Fresenius Kabi has announced the launch of its generic for Teva’s Trisenox® (arsenic trioxide) 10mg/10mL for injection. The product is indicated for use in combination with tretinoin to treat adults who have newly diagnosed, low-risk acute promyelocytic leukemia (APL) and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. It is also indicated for induction of remission and consolidation in patients who have APL and are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy. These patients must have APL characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

The FDA granted approval for Fresenius Kabi’s generic in August 2018. It is currently the only generic available for Trisenox in the United States. First approved in 2000, brand name Trisenox is now available only in 12mg/6mL vials. The brand name 10mg/10mL formulation has been discontinued.

Recommended dosing for arsenic trioxide depends on the indication, but requires an induction and a consolidation phase for both indications. A black box warning cautions that patients treated with the drug can develop potentially fatal differentiation syndrome as well as QT interval prolongation and ventricular arrhythmia.

Fresenius Kabi’s generic has a wholesale acquisition cost (WAC) of $3,950 per box. Each box contains 10 10mL vials.

Last Updated Monday, January 21, 2019 - 08:17 AM.