What are the most common side effects of ARSENIC TRIOXIDE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for ARSENIC TRIOXIDE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is ARSENIC TRIOXIDE the same as Trisenox?

Trisenox is a brand name for ARSENIC TRIOXIDE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

ARSENIC TRIOXIDE

Q: What is ARSENIC TRIOXIDE used for?

ARSENIC TRIOXIDE (brand name Trisenox) is a Other indicated for 17) translocation or PML/RAR-alpha gene expression. ( 1.1 ) For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy.

Q: How does ARSENIC TRIOXIDE work?

ARSENIC TRIOXIDE works through the following mechanism: 12.1 Mechanism of Action The mechanism of action of TRISENOX 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 promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha..

Other

Brand names: Trisenox

Intravenous

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of TRISENOX 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 promyelocytic leukemia (PML)-retinoic acid receptor (RAR)-alpha.

Indications

17) translocation or PML/RAR-alpha gene expression. ( 1.1 ) 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. 1.2 Relapsed or Refractory APL TRISENOX is indicated for induction of remission and consolidation in patients with APL who are refractory to

or have relapsed from

Contraindications

• 4 CONTRAINDICATIONS TRISENOX is contraindicated in patients with hypersensitivity to arsenic. Hypersensitivity to arsenic. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Elevated aspartate aminotransferase (AST), alkaline phosphatase and serum bilirubin have occurred in patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin
Advise of potential risk to a fetus and use of effective contraception
1 Differentiation Syndrome Differentiation syndrome, which may be life-threatening or fatal, has been observed in patients with acute promyelocytic leukemia (APL) treated with TRISENOX
In the clinical trials of patients with newly-diagnosed low-risk APL treated with TRISENOX in combination with tretinoin, 11% experienced QTc (Framingham formula) prolongation > 450 msec for men and > 460 msec for women throughout the treatment cycles

Known Side Effects

10 documented side effects by frequency

Fatigue

1-10%

Nausea

1-10%

Diarrhea

1-10%

Headache

1-10%

Drug Not Working

1-10%

Shortness of Breath

1-10%

Fever

1-10%

Dizziness

1-10%

Joint Pain

1-10%

Vomiting

1-10%

Community Discussions

No community discussions found for ARSENIC TRIOXIDE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → ARSENIC TRIOXIDE openFDA label JSON → ARSENIC TRIOXIDE FAERS adverse-event reports → ARSENIC TRIOXIDE ClinicalTrials.gov → completed Phase 2+ trials of ARSENIC TRIOXIDE

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Formulations

Dosage Forms

Tablet

Route

Intravenous