Trisenox 2 mg/mL

Arsenic Trioxide · INJECTION, SOLUTION · Cephalon, LLC

No Recall HistoryCurrently in Shortage

Plain English

Trisenox is a injection, solution containing arsenic trioxide at 2 mg/mL, taken intravenous. Manufactured by Cephalon, LLC.

Key Facts

Brand Name: Trisenox
Generic Name: Arsenic Trioxide
NDC Code (Product): 63459-601
Manufacturer: Cephalon, LLC
Strength: 2 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA021248
Marketing Start: 12/22/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

electrocardiogram qt prolonged261 reports

differentiation syndrome214 reports

off label use163 reports

pyrexia107 reports

pneumonia82 reports

alanine aminotransferase increased79 reports

febrile neutropenia78 reports

dyspnoea74 reports

pleural effusion73 reports

neutropenia72 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. ( 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 ) 1.1 Newly-Diagnosed Low-Risk APL TRISENOX is 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. 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, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

Dosage & Administration

2 DOSAGE AND 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 ) 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 ) Relapsed or refractory APL: Induction: Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days. ( 2.2 ) Consolidation: Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. ( 2.2 ) 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-…

Contraindications

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

Drug Interactions

7 DRUG INTERACTIONS Drugs That Can Prolong the QT/QTc Interval Concomitant use of these drugs and TRISENOX may increase the risk of serious QT/QTc interval prolongation [see Warnings and Precautions ( 5.1 )] . Discontinue or replace with an alternative drug that does not prolong the QT/QTc interval while the patient is using TRISENOX. Monitor ECGs more frequently in patients when it is not feasible to avoid concomitant use. Drugs That Can Lead to Electrolyte Abnormalities Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation [see Warnings and Precautions ( 5.1 )] . Avoid concomitant use of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and TRISENOX. Drugs That Can Lead to Hepatotoxicity Concomitant use of these drugs and TRISENOX, particularly when given in combination with tretinoin, may increase the risk of serious hepatotoxicity [see Warnings and Precautions ( 5.4 )] . Discontinue or replace with an alternative drug that does not cause hepatotoxicity while the patient is using TRISENOX. Monitor liver function tests more frequently in patients when it …

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Differentiation Syndrome [see Warnings and Precautions ( 5.1 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.2 )] Encephalopathy [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Carcinogenesis [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (> 30%) are nausea, cough, fatigue, pyrexia, headache, abdominal pain, vomiting, tachycardia, diarrhea, dyspnea, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QTc prolongation, rigors, sore throat, arthralgia, paresthesia, and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly-Diagnosed Low-Risk APL The s…

Frequently Asked Questions

What is Trisenox used for?

Trisenox contains Arsenic Trioxide. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Trisenox a controlled substance?

Trisenox is not classified as a controlled substance by the DEA.

What is the generic name for Trisenox?

The generic name for Trisenox is Arsenic Trioxide. There are 12 other brand versions of Arsenic Trioxide.

What is the NDC code for Trisenox 2 mg/mL?

The NDC (National Drug Code) for Trisenox 2 mg/mL is 63459-601, listed by Cephalon, LLC.

Product NDC

63459-601

Package NDC

63459-601-06

Other Arsenic Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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