Chemotherapy / Oncology — Hematologic

Trisenox (arsenic trioxide)

Teva Pharmaceuticals; generics available · Antineoplastic Agent — Arsenic Compound

FDA Approved 2000 Intravenous (IV) infusion Specialty Medication
Arsenic Trioxide Injection 10mg/10mL 1mg/mL sterile solution, Trisenox generic equivalent, Teva Pharmaceuticals

What is Trisenox? Trisenox (arsenic trioxide) is an antineoplastic agent used in combination with all-trans retinoic acid (ATRA) for the induction and consolidation of adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) with PML/RARα gene expression.

About Trisenox

Brand NameTrisenox
Generic / INNarsenic trioxide
Drug ClassAntineoplastic Agent — Arsenic Compound
ManufacturerTeva Pharmaceuticals; generics available
AdministrationIntravenous (IV) infusion
FDA Approval2000
📦 10 mg/10 mL (1 mg/mL) sterile solution, single-dose vials. Also available as generic arsenic trioxide from multiple manufacturers.

FDA-Approved Uses for Trisenox

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • Newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) — in combination with ATRA
  • Relapsed or refractory APL — in patients who have received retinoid and anthracycline chemotherapy
Biomarker Note: PML/RARα gene expression (confirmed by RT-PCR, FISH, or cytogenetics) is required to confirm APL diagnosis and eligibility. Arsenic trioxide is specifically active in PML/RARα-positive APL.

How Does Trisenox Work?

Arsenic trioxide causes morphological changes and DNA fragmentation in APL cells, triggering apoptosis. It damages or degrades the PML/RARα fusion protein (the driver of APL) and causes differentiation of APL cells — similar to but complementary to the mechanism of all-trans retinoic acid (ATRA).

Dosage & Administration

Dosing is indication-specific (induction vs. consolidation) and based on body weight (mg/kg). Administered as a 2-hour IV infusion; may extend to 4 hours if acute vasomotor reactions occur. Precise schedule is determined by the treating hematologist.

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

APL DIFFERENTIATION SYNDROME — can be fatal; monitor closely and treat immediately with dexamethasone if suspected. QT interval prolongation and torsades de pointes — EKG monitoring required. Electrolyte monitoring essential (hypokalemia and hypomagnesemia increase QT risk). Embryo-fetal toxicity.

⛔ Serious Warnings & Precautions
  • APL differentiation syndrome — can be fatal
  • QT prolongation / torsades de pointes
  • Electrolyte abnormalities
  • Embryo-fetal toxicity

Common Side Effects

  • Fatigue
  • Nausea
  • Vomiting
  • Peripheral neuropathy
  • Hyperglycemia
  • Edema
  • Cough
  • QT prolongation

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Store at room temperature 15°C to 30°C (59°F to 86°F). Do not freeze.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Trisenox is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Trisenox. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Trisenox

Trisenox (arsenic trioxide) is an IV chemotherapy approved for acute promyelocytic leukemia (APL). Used with all-trans retinoic acid (ATRA), it is a highly effective treatment for PML/RARα-positive APL and has transformed outcomes for this disease.

APL differentiation syndrome (formerly retinoic acid syndrome) is a potentially fatal complication that occurs when leukemia cells differentiate rapidly. Symptoms include fever, pulmonary infiltrates, respiratory distress, and fluid retention. It requires immediate treatment with dexamethasone.

Yes — arsenic trioxide can prolong the QT interval on EKG, increasing the risk of a dangerous arrhythmia called torsades de pointes. Continuous EKG monitoring and strict electrolyte management (especially potassium and magnesium) are required during treatment.

Yes. Generic arsenic trioxide 10 mg/10 mL injection is available from multiple manufacturers, including Teva. Trisenox is the original brand.

Related Medications

ATRA (tretinoin/Vesanoid)  ·  Anthracyclines (daunorubicin/idarubicin)  ·  Gemtuzumab ozogamicin (Mylotarg)

Related Conditions

Acute promyelocytic leukemia (APL)  ·  Acute myeloid leukemia (AML)  ·  Hematologic malignancies

Comparisons

Vidaza

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.