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Arsenic Trioxide Dosage

Applies to the following strength(s): 1 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Acute Promyelocytic Leukemia

-Induction: IV infusion of 0.15 mg/kg over 1 to 2 hours once a day until bone marrow remission.
Maximum Dose (Induction): Not to exceed 60 doses.

-Consolidation: IV infusion of 0.15 mg/kg over 1 to 2 hours once a day; begin 3 to 6 weeks after completion of induction therapy.
Maximum Dose (Consolidation): 25 doses over a period up to 5 weeks.

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (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.

Usual Pediatric Dose for Acute Promyelocytic Leukemia

Age 4 Years and Older:
-Induction: IV infusion of 0.15 mg/kg over 1 to 2 hours once a day until bone marrow remission.
Maximum Dose (Induction): Not to exceed 60 doses.

-Consolidation: IV infusion of 0.15 mg/kg over 1 to 2 hours once a day; begin 3 to 6 weeks after completion of induction therapy.
Maximum Dose (Consolidation): 25 doses over a period up to 5 weeks.

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (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.

Renal Dose Adjustments

-Mild and Moderate Renal Impairment (CrCl 30 to 80 mL/min): Use with caution.
-Severe Renal Impairment (CrCl less than 30 mL/min): May require dose reduction; however, no specific guidelines have been suggested. Use with caution and monitor for toxicity.

Liver Dose Adjustments

-Mild and Moderate Hepatic Impairment (Child-Pugh A and B): Use with caution.
-Severe Hepatic Impairment (Child-Pugh C): Use with caution; monitor for toxicity.

Dose Adjustments

Occurrence of Severe Non-Hematologic Adverse Reaction (e.g., neurologic or dermatologic toxicity): Consider delaying infusion of this drug until the event has resolved to Grade 1 or less.

Precautions

US BOXED WARNING:
APL DIFFERENTIATION SYNDROME:
-Patients with acute promyelocytic leukemia (APL) treated with this drug have experienced symptoms similar to a sometimes fatal 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.
-At the first signs that could suggest the syndrome, immediately initiate high-dose steroids (dexamethasone 10 mg IV twice a day) irrespective of the leukocyte count, and continue for at least 3 days or longer until signs and symptoms have abated.
-The majority of patients do not require termination of this drug while receiving treatment for APL differentiation syndrome.
CARDIAC CONDUCTION ABNORMALITIES:
-This drug can cause QT interval prolongation and complete atrioventricular block.
-QT prolongation can lead to a torsade de pointes (TdP)-type ventricular arrhythmia, which can be fatal.
-Before initiating therapy, perform a 12-lead ECG, assess serum electrolytes and creatinine, correct preexisting electrolyte abnormalities, and consider discontinuing drugs known to prolong the QT interval.

Safety and efficacy have not been established in patients younger than 4 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:
-May extend IV infusion duration up to 4 hours if vasomotor reactions are observed; a central venous catheter is not required.

Storage Requirements:
-Consult the manufacturer product information.

Reconstitution/Preparation Techniques:
-Consult the manufacturer product information.

IV Compatibility:
-Do not mix this drug with other medications.

General:
-Overdosage management: Consult the manufacturer product information.

Monitoring:
-Cardiovascular: ECG, QT/QTc interval, heart beat
-Laboratory: Electrolytes, creatinine, glucose; hepatic, renal, hematologic, and coagulation profiles
-Nervous System: Neuropathy signs/symptoms
-Oncologic: APL differentiation syndrome signs/symptoms; development of second primary malignancies.

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