Arsenic Trioxide

The mechanism of action of Arsenic Trioxide 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 PML-RAR-alpha.

• In combination with tretinoin for treatment of adults with newly-diagnosed low-risk APL characterized by t(15;17) translocation or PML/RAR-alpha gene expression
• Induction of remission and consolidation in patients with APL refractory to or relapsed from retinoid and anthracycline chemotherapy

The mechanism of action of Arsenic Trioxide 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 PML-RAR-alpha.

Arsenic Trioxide induces apoptosis in NB4 leukemia cells and causes damage or degradation of the PML-RAR-alpha fusion protein, thereby stopping cancer cell growth.

Newly-diagnosed low-risk APL (Induction): 0.15 mg/kg/day IV daily with tretinoin until bone marrow remission (max 60 days).
Newly-diagnosed low-risk APL (Consolidation): 0.15 mg/kg/day IV for 5 days per week (weeks 1-4) of each 8-week cycle for 4 cycles with tretinoin.
Relapsed/refractory APL (Induction): 0.15 mg/kg/day IV daily until bone marrow remission (max 60 days).
Relapsed/refractory APL (Consolidation): 0.15 mg/kg/day IV daily for 25 doses over up to 5 weeks.

This medicine is given as an intravenous infusion by a healthcare professional. Kindly do not self administer.

Arsenic Trioxide is an injection medicine given by healthcare professionals. You cannot miss a dose yourself.

Common (>30%): Nausea, cough, fatigue, pyrexia, headache, abdominal pain, vomiting, tachycardia, diarrhea, dyspnea, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QTc prolongation, rigors, sore throat, arthralgia, paresthesia, pruritus.

Hepatotoxicity: Monitor hepatic function tests at least twice weekly during induction and at least once weekly during consolidation. Withhold for certain elevations in AST, alkaline phosphatase and bilirubin and resume at reduced dose upon resolution. Arsenic trioxide is a human carcinogen; monitor for second primary malignancies. Embryo-fetal toxicity: Can cause fetal harm; use effective contraception.

Hypersensitivity to arsenic.

Drugs that prolong QT/QTc interval: May increase risk of serious QT/QTc prolongation; avoid or use alternative; monitor ECGs frequently.
Drugs that cause electrolyte abnormalities: May increase risk of serious QT/QTc prolongation; avoid; monitor electrolytes frequently.
Drugs that cause hepatotoxicity: May increase risk of serious hepatotoxicity (especially with tretinoin); use alternative; monitor liver function tests frequently.

Can be used with or without food.

Pregnancy Category D. Arsenic Trioxide may cause fetal harm during pregnancy.

No adequate information is available regarding use during lactation.

Safety and efficacy in combination with tretinoin in pediatric patients has not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients.

Renal impairment: Exposure may be higher in patients with severe renal impairment.
Hepatic impairment: Limited data available; caution is advised.

Treatment of overdose is by supportive and symptomatic therapy.

Store at 20°C to 25°C. Do not freeze. Arsenic Trioxide is a hazardous drug; follow special handling and disposal procedures.

Arsenic Trioxide