Arsenic Trioxide
Arsenic Trioxide is a chemotherapy agent used primarily in the treatment of a specific type of acute myeloid leukemia called acute promyelocytic leukemia (APL). It is typically used when the disease has not responded to other treatments or has returned after prior therapy.
Arsenic Trioxide is an anticancer medication used to treat acute promyelocytic leukemia (APL) that has relapsed or not responded to other treatments.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XX27
- RxNorm
- 18631
- Generic
- Arsenic Trioxide
- Class
- atc-l01
- Brands
- Trisenox
- Availability
- otc
- Pregnancy
- D
- Lactation
- unsafe
- Half-life (h)
- 12
- Onset (min)
- 0
- Duration (h)
- 0
- Routes
- intravenous
- Forms
- injectable solution
- Regions
- United States, European Union, Canada, Japan, Australia
- Monitoring
- ECG for QT prolongation, serum electrolytes, complete blood count, liver function tests, coagulation parameters
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid
Arsenic trioxide should not be used during pregnancy due to teratogenic potential. Discontinue if pregnancy occurs during treatment.
regular fetal monitoring and pregnancy testing
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid
Avoid use unless benefits to mother outweigh fetal risks
fetal ultrasound and monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
Consider delaying treatment until after delivery if clinically feasible
fetal well-being monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
Do not breastfeed during treatment with arsenic trioxide and for at least 2 weeks after last dose
none applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children 2 17 yearsweight-based dosing
Approved for use in pediatric patients with relapsed or refractory acute promyelocytic leukemia. Monitor closely for cardiac and hepatic effects.
ECG monitoring, liver function tests, complete blood counts
Use with caution and monitor for adverse effects.
geriatric
65 years and olderno specific adjustment
Use with caution due to potential increased sensitivity. Monitor cardiac function closely.
regular cardiac monitoring, renal function assessment
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderatemonitor closely
Use with caution. No formal dose adjustment recommended but monitor renal function closely.
regular serum creatinine and renal function tests
Use with caution and monitor for adverse effects.
renal_impairment
severereduce dose or avoid
Use with extreme caution in severe renal impairment. Consider dose reduction.
frequent renal function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific adjustment
Use with caution. Monitor liver function tests.
regular liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severereduce dose
Use with caution. Dose reduction may be required in moderate to severe hepatic impairment.
frequent liver function tests and bilirubin monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for treatment of relapsed/refractory acute promyelocytic leukemia
Drug class
Classification as antineoplastic agent for acute promyelocytic leukemia
Primary indication
Primary therapeutic use for APL treatment
Mechanism of action
Pharmacological mechanism of action
Treatment of acute promyelocytic leukemia (APL) with the t(15;17) translocation or PML-RARalpha fusion, particularly in patients who have relapsed after or are refractory to retinoid and chemotherapy treatments.
The exact mechanism is not fully understood, but arsenic trioxide is believed to induce differentiation of malignant promyelocytes into mature cells and promote apoptosis (programmed cell death) of cancer cells. It may also target the PML-RARalpha protein that drives APL cell growth.
Administered intravenously under close medical supervision, typically in a hospital setting. Requires monitoring of electrolytes, liver function, and cardiac rhythm (ECG) during treatment due to risks of electrolyte abnormalities and cardiac arrhythmias including QT prolongation. May cause differentiation syndrome (formerly called APL syndrome) with symptoms such as fever, difficulty breathing, and weight gain.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 26, 2026. · Read our editorial policy