TRISENOX- arsenic trioxide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)

Available from:

Cephalon, Inc.

INN (International Name):

ARSENIC TRIOXIDE - UNII:C96613F5AV)

Composition:

ARSENIC TRIOXIDE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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. TRISENOX is contraindicated in patients who are hypersensitive to arsenic. Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1)] and findings in animal studies, TRISENOX can cause fetal harm when administered to a pregnant woman. Arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see Data) . A related trivalent arsenic, sodium arsen

Product summary:

TRISENOX (arsenic trioxide) injection is supplied as a sterile, clear, colorless solution in 10 mL glass, single-use ampules. NDC 63459-600-10 10 mg/10 mL (1 mg/mL) ampule in packages of ten ampules. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). Do not freeze. TRISENOX is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Authorization status:

New Drug Application

Summary of Product characteristics

TRISENOX- ARSENIC TRIOXIDE INJECTION, SOLUTION
CEPHALON, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRISENOX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRISENOX.
TRISENOX (ARSENIC TRIOXIDE) INJECTION, FOR INTRAVENOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
WARNING: DIFFERENTIATION SYNDROME,
CARDIAC CONDUCTION ABNORMALITIES, AND ENCEPHALOPATHY INCLUDING
WERNICKE’S
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS TREATED WITH TRISENOX MAY DEVELOP DIFFERENTIATION SYNDROME,
WHICH CAN BE FATAL. IF
SYMPTOMS OCCUR, INITIATE HIGH-DOSE STEROIDS IMMEDIATELY AND MONITOR
HEMODYNAMICS. (5.1)
TRISENOX CAN CAUSE QT INTERVAL PROLONGATION AND VENTRICULAR
ARRHYTHMIA, WHICH CAN BE FATAL.
BEFORE ADMINISTERING TRISENOX, ASSESS THE QT INTERVAL, CORRECT
ELECTROLYTE ABNORMALITIES, AND
CONSIDER DISCONTINUING DRUGS KNOWN TO PROLONG QT INTERVAL. DO NOT
ADMINISTER TRISENOX TO
PATIENTS WITH VENTRICULAR ARRHYTHMIA OR PROLONGED QTCF. (2.3, 5.2) ENCEPHALOPATHY INCLUDING WERNICKE’S ENCEPHALOPATHY (WE) OCCURRED IN
PATIENTS RECEIVING
TRISENOX. IF WERNICKE’S ENCEPHALOPATHY IS SUSPECTED, IMMEDIATELY
INTERRUPT TRISENOX TREATMENT
AND INITIATE PARENTERAL THIAMINE. (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 06/2019
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)
DOSAGE AND ADMINISTRATION
Newly-diagnosed low-risk APL:
_Induction:_ 0.15 mg/kg intravenously daily in combination with
tretinoin until bone marrow remi