Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Trisenox Approved for Certain Patients with APL
Teva news release; 2018 Jan 15
The FDA has approved the use of Trisenox (arsenic trioxide) injection in combination with tretinoin for the treatment of certain adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL).
Indications: Trisenox is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline (ATRA) chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. |
Dosage and administration:
- For induction, administer 0.15 mg/kg daily intravenously; do not exceed 60 doses.
- Begin consolidation 3 to 6 weeks after induction. Administer 0.15 mg/kg daily intravenously for 25 doses over a period up to 5 weeks.
Efficacy and safety: Approval is based on results of an open-label, single-arm, non-comparative study involving 40 patients previously treated with ATRA. 7 in every 10 achieved complete response.
Side effects/risks: The most common adverse reactions are leukocytosis, gastrointestinal, fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness.
Teva announces US FDA approval of Trisenox (arsenic trioxide) injection for first line treatment of acute promyelocytic leukemia. [news release]. Jerusalem: Teva Pharmaceutical Industries Ltd. January 15, 2018. http://www.tevapharm.com/news/teva_announces_u_s_fda_approval_of_trisenox_arsenic_trioxide_injection_for_first_line_treatment_of_acute_promyelocytic_leukemia_01_18.aspx. Accessed January 16, 2018.
Trisenox [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc., 2018. http://www.trisenox.com/trisenox-prescribing-information.pdf. Accessed January 16, 2018.