Arsenic Trioxide

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The FDA recommends, but does not require, genetic testing prior to initiating or reinitiating treatment with arsenic trioxide.

Arsenic trioxide is used in the treatment of acute promyelocytic leukemia (APL) which is characterized by the translocation t(15;17) and PML/RAR-alpha fusion protein product of PML and RARA genes.

Excerpt from the arsenic trioxide drug label:
"Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR-alpha."

"Some patients with APL treated with TRISENOX have experienced symptoms similar to a
syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized
by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This
syndrome can be fatal. The management of the syndrome has not been fully studied, but high-dose steroids have been used
at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs
that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or
radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously BID) should be immediately initiated,
irrespective of the leukocyte count, and continued for at least 3 days or longer until signs and symptoms have abated. The
majority of patients do not require termination of TRISENOX therapy during treatment of the APL differentiation syndrome."
"Nine of 40 patients with APL treated with TRISENOX, at a dose of 0.15 mg/kg, experienced the APL differentiation syndrome"

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Arsenic Trioxide drug label PDF.