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ARSENIC TRIOXIDE

ARSENIC TRIOXIDE

Manufacturer: Novadoz Pharmaceuticals LLC

Score: 148.0

Quick Summary

Arsenic trioxide is used for the treatment of acute promyelocytic leukemia (APL) that is refractory to, or has relapsed from, retinoid and anthracycline chemotherapy. It works by inducing apoptosis in leukemia cells and has shown efficacy in achieving complete remission. However, it carries significant risks, including differentiation syndrome, cardiac conduction abnormalities, and encephalopathy. Dosing recommendations include an initial induction phase followed by a consolidation phase, with careful monitoring for adverse reactions and adjustment of doses as necessary. Special considerations are needed for use in pregnant women, nursing mothers, pediatric patients, and geriatric patients due to potential toxicity and limited data on safety and efficacy in these populations.

Key Clinical Findings and Indications

  • Treatment of acute promyelocytic leukemia (APL) refractory to, or relapsed from, retinoid and anthracycline chemotherapy
  • Induces apoptosis in leukemia cells
  • Achieves complete remission in a significant portion of patients

Important Safety Information

Warning

Differentiation syndrome, cardiac conduction abnormalities, and encephalopathy, including Wernicke's encephalopathy, have been reported with the use of arsenic trioxide.

Contraindications

  • Hypersensitivity to arsenic

Adverse Reactions

  • Differentiation syndrome
  • Cardiac conduction abnormalities
  • Encephalopathy, including Wernicke's encephalopathy
  • Hepatotoxicity
  • 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, and pruritus

Dosing Recommendations

General Guidance

Dose adjustments are necessary for patients with renal impairment, hepatic impairment, or those experiencing adverse reactions such as differentiation syndrome, QTc prolongation, or hepatotoxicity.

Relapsed or refractory APL

Adult Dose

0.15 mg/kg/day intravenously daily until bone marrow remission or up to a maximum of 60 days for induction, followed by 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks for consolidation

Pediatric Dose

0.15 mg/kg/day intravenously daily, with similar dosing regimen as adults

Special Population Considerations

Pregnancy

  • May cause fetal harm
  • Advise pregnant women of the potential risk to a fetus
  • Use effective contraception during treatment and for 6 months after the final dose

Nursing Mothers

  • It is not known whether arsenic trioxide is excreted in human milk
  • Advise nursing mothers to discontinue breastfeeding during treatment with arsenic trioxide

Pediatric Use

  • The safety and efficacy of arsenic trioxide have been established in pediatric patients with relapsed or refractory APL
  • Similar dosing regimen as adults, with careful monitoring for adverse reactions

Geriatric Use

  • No overall differences in safety or effectiveness were observed between geriatric patients and younger patients
  • Careful monitoring for adverse reactions is necessary due to potential for decreased renal function and other comorbidities
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