Trisenox

(Arsenic Trioxide)

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Dosage & Administration

Newly-diagnosed low-risk APL:

Induction:

Administer 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days. (

2.1 Recommended Dosage for Newly-Diagnosed Low-Risk Acute Promyelocytic Leukemia (APL)

A treatment course for patients with newly-diagnosed low-risk APL consists of 1 induction cycle and 4 consolidation cycles.

* For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission but not to exceed 60 days (see Table 1).

* For the consolidation cycles, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin (see Table 1). Omit tretinoin during weeks 5-6 of the fourth cycle of consolidation.

Table 1: Recommended Dosage of TRISENOX in Combination with Tretinoin

Induction (1 cycle)

TRISENOX

0.15 mg/kg once daily intravenously

until marrow remission but not to exceed 60 days

Tretinoin^a

22.5 mg/m²twice daily orally

until marrow remission but not to exceed 60 days

Consolidation (4 cycles)

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

TRISENOX

0.15 mg/kg once

daily intravenously

Days

1-5

Tretinoin^a

22.5 mg/m²twice daily orally

Days

1-7

Days^b

1-7

^aRounded to the nearest 10 mg increment

^bOmitted during the 4th cycle of consolidation

Differentiation syndrome prophylaxis consisting of prednisone 0.5 mg/kg daily from day 1 until the end of induction cycle with TRISENOX and tretinoin is recommended.

)

*

Consolidation:

Administer 0.15 mg/kg/day intravenously daily for 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin. (

2.1 Recommended Dosage for Newly-Diagnosed Low-Risk Acute Promyelocytic Leukemia (APL)

A treatment course for patients with newly-diagnosed low-risk APL consists of 1 induction cycle and 4 consolidation cycles.

Table 1: Recommended Dosage of TRISENOX in Combination with Tretinoin

Induction (1 cycle)

TRISENOX

0.15 mg/kg once daily intravenously

until marrow remission but not to exceed 60 days

Tretinoin^a

22.5 mg/m²twice daily orally

until marrow remission but not to exceed 60 days

Consolidation (4 cycles)

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

TRISENOX

0.15 mg/kg once

daily intravenously

Days

1-5

Tretinoin^a

22.5 mg/m²twice daily orally

Days

1-7

Days^b

1-7

^aRounded to the nearest 10 mg increment

^bOmitted during the 4th cycle of consolidation

Differentiation syndrome prophylaxis consisting of prednisone 0.5 mg/kg daily from day 1 until the end of induction cycle with TRISENOX and tretinoin is recommended.

)

Relapsed or refractory APL:

Induction:

Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days. (

2.2 Recommended Dosage
for Relapsed
or Refractory APL

A treatment course for patients with relapsed or refractory APL consists of 1 induction cycle and 1 consolidation cycle

[see Clinical Studies ]

* For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily until bone marrow remission or up to a maximum of 60 days.
* For the consolidation cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. Begin consolidation 3 to 6 weeks after completion of induction cycle.

)
*

Consolidation:

Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. (

2.2 Recommended Dosage
for Relapsed
or Refractory APL

A treatment course for patients with relapsed or refractory APL consists of 1 induction cycle and 1 consolidation cycle

[see Clinical Studies ]

)

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Trisenox Prescribing Information

Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hepatopathy, and multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold TRISENOX

[see Dosage and Administration , Warnings and Precautions ].

Cardiac Conduction Abnormalities:

TRISENOX

can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering

TRISENOX,

assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer TRISENOX to patients with a ventricular arrhythmia or prolonged QTc interval. Withhold

TRISENOX

until resolution and resume at reduced dose for

QTc

prolongation

[see Dosage and Administration , Warnings and Precautions ].

Encephalopathy: Serious encephalopathy, including Wernicke's, has occurred with TRISENOX. Wernicke's is a neurologic emergency. Consider testing thiamine levels in patients at risk for thiamine deficiency. Administer parenteral thiamine in patients with or at risk for thiamine deficiency. Monitor patients for neurological symptoms and nutritional status while receiving TRISENOX. If Wernicke's encephalopathy is suspected, immediately interrupt TRISENOX and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize

[see Warnings and Precautions ]

TRISENOX is an arsenical indicated:

In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
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.

Newly-diagnosed low-risk APL:

Induction:

Administer 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days. (

2.1 Recommended Dosage for Newly-Diagnosed Low-Risk Acute Promyelocytic Leukemia (APL)

A treatment course for patients with newly-diagnosed low-risk APL consists of 1 induction cycle and 4 consolidation cycles.

For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission but not to exceed 60 days (see Table 1).

For the consolidation cycles, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin (see Table 1). Omit tretinoin during weeks 5-6 of the fourth cycle of consolidation.

Table 1: Recommended Dosage of TRISENOX in Combination with Tretinoin

Induction (1 cycle)

TRISENOX

0.15 mg/kg once daily intravenously

until marrow remission but not to exceed 60 days

Tretinoin^a

22.5 mg/m²twice daily orally

until marrow remission but not to exceed 60 days

Consolidation (4 cycles)

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

TRISENOX

0.15 mg/kg once

daily intravenously

Days

1-5

Tretinoin^a

22.5 mg/m²twice daily orally

Days

1-7

Days^b

1-7

^aRounded to the nearest 10 mg increment

^bOmitted during the 4th cycle of consolidation

Differentiation syndrome prophylaxis consisting of prednisone 0.5 mg/kg daily from day 1 until the end of induction cycle with TRISENOX and tretinoin is recommended.

)

Consolidation:

Administer 0.15 mg/kg/day intravenously daily for 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin. (

2.1 Recommended Dosage for Newly-Diagnosed Low-Risk Acute Promyelocytic Leukemia (APL)

A treatment course for patients with newly-diagnosed low-risk APL consists of 1 induction cycle and 4 consolidation cycles.

For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission but not to exceed 60 days (see Table 1).

For the consolidation cycles, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin (see Table 1). Omit tretinoin during weeks 5-6 of the fourth cycle of consolidation.

Table 1: Recommended Dosage of TRISENOX in Combination with Tretinoin

Induction (1 cycle)

TRISENOX

0.15 mg/kg once daily intravenously

until marrow remission but not to exceed 60 days

Tretinoin^a

22.5 mg/m²twice daily orally

until marrow remission but not to exceed 60 days

Consolidation (4 cycles)

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

TRISENOX

0.15 mg/kg once

daily intravenously

Days

1-5

Tretinoin^a

22.5 mg/m²twice daily orally

Days

1-7

Days^b

1-7

^aRounded to the nearest 10 mg increment

^bOmitted during the 4th cycle of consolidation

Differentiation syndrome prophylaxis consisting of prednisone 0.5 mg/kg daily from day 1 until the end of induction cycle with TRISENOX and tretinoin is recommended.

)

Relapsed or refractory APL:

Induction:
Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days. (
2.2 Recommended Dosage
for Relapsed
or Refractory APL
A treatment course for patients with relapsed or refractory APL consists of 1 induction cycle and 1 consolidation cycle
[see Clinical Studies ]
.
- For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily until bone marrow remission or up to a maximum of 60 days.
- For the consolidation cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. Begin consolidation 3 to 6 weeks after completion of induction cycle.
)
Consolidation:
Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. (
2.2 Recommended Dosage
for Relapsed
or Refractory APL
A treatment course for patients with relapsed or refractory APL consists of 1 induction cycle and 1 consolidation cycle
[see Clinical Studies ]
.
- For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily until bone marrow remission or up to a maximum of 60 days.
- For the consolidation cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. Begin consolidation 3 to 6 weeks after completion of induction cycle.
)

Lactation
: Advise not to breastfeed. (
8.2 Lactation
Risk Summary
Arsenic trioxide is excreted in human milk. There are no data on the effects of arsenic trioxide on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with TRISENOX and for 2 weeks after the final dose.
)
Renal Impairment
: Monitor patients with severe renal impairment (creatinine clearance less than 30 mL/min) for toxicity when treated with TRISENOX; dose reduction may be warranted. (
8.6 Renal Impairment
Exposure of arsenic trioxide may be higher in patients with severe renal impairment
[see Clinical Pharmacology ]
. Monitor patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min) frequently for toxicity; a dose reduction may be warranted.
The use of TRISENOX in patients on dialysis has not been studied.
)
Hepatic Impairment
: Monitor patients with severe hepatic impairment (Child-Pugh Class C) for toxicity when treated with TRISENOX. (
8.7 Hepatic Impairment
Since limited data are available across all hepatic impairment groups, caution is advised in the use of TRISENOX in patients with hepatic impairment
[see Clinical Pharmacology ]
. Monitor patients with severe hepatic impairment (Child-Pugh Class C) frequently for toxicity.
)

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