ARSENIC TRIOXIDE

Other

Brand names: Trisenox

Intravenous

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of TRISENOX is not completely understood. Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha.

Indications

17) translocation or PML/RAR-alpha gene expression. ( 1.1 ) For induction of remission and consolidation in patients with 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. 1.2 Relapsed or Refractory APL TRISENOX is indicated for induction of remission and consolidation in patients with APL who are refractory to

or have relapsed from

Contraindications

• 4 CONTRAINDICATIONS TRISENOX is contraindicated in patients with hypersensitivity to arsenic. Hypersensitivity to arsenic. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Elevated aspartate aminotransferase (AST), alkaline phosphatase and serum bilirubin have occurred in patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin
Advise of potential risk to a fetus and use of effective contraception
1 Differentiation Syndrome Differentiation syndrome, which may be life-threatening or fatal, has been observed in patients with acute promyelocytic leukemia (APL) treated with TRISENOX
In the clinical trials of patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin, 11% experienced QTc (Framingham formula) prolongation > 450 msec for men and > 460 msec for women throughout the treatment cycles

Known Side Effects

10 documented side effects by frequency

Fatigue

1-10%

Nausea

1-10%

Diarrhea

1-10%

Headache

1-10%

Drug Not Working

1-10%

Shortness of Breath

1-10%

Fever

1-10%

Dizziness

1-10%

Joint Pain

1-10%

Vomiting

1-10%

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Formulations

Dosage Forms

Tablet

Route

Intravenous