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, LLC

INN (International Name):

ARSENIC TRIOXIDE - UNII:C96613F5AV)

Composition:

ARSENIC TRIOXIDE 2 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 with hypersensitivity 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:

How Supplied TRISENOX (arsenic trioxide) injection is supplied as a sterile, clear, colorless solution in 10 mL glass, single-dose vials. NDC 63459-601-06 : 12 mg/6 mL (2 mg/mL) vial in packages of ten vials. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. TRISENOX is a hazardous drug. Follow applicable special handling and disposal procedures.1

Authorization status:

New Drug Application

Summary of Product characteristics

TRISENOX- ARSENIC TRIOXIDE INJECTION, SOLUTION
CEPHALON, LLC
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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 USE
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 WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL) TREATED WITH TRISENOX
HAVE
EXPERIENCED SYMPTOMS OF DIFFERENTIATION SYNDROME, WHICH MAY BE
LIFE-THREATENING
OR FATAL. IF DIFFERENTIATION SYNDROME IS SUSPECTED, IMMEDIATELY
INITIATE HIGH-DOSE
CORTICOSTEROIDS AND HEMODYNAMIC MONITORING UNTIL RESOLUTION.
TEMPORARILY WITHHOLD
TRISENOX. (2.3, 5.1) 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
VENTRICULAR ARRHYTHMIA OR PROLONGED QTC INTERVAL. WITHHOLD TRISENOX
UNTIL RESOLUTION
AND RESUME AT REDUCED DOSE FOR QTC PROLONGATION. (2.3, 5.2)
SERIOUS ENCEPHALOPATHY, INCLUDING WERNICKE'S, HAS OCCURRED WITH
TRISENOX. IF
WERNICKE'S ENCEPHALOPATHY IS SUSPECTED, IMMEDIATELY INTERRUPT TRISENOX
AND
INITIATE PARENTERAL THIAMINE. MONITOR UNTIL SYMPTOMS RESOLVE OR
IMPROVE AND
THIAMINE LEVELS NORMALIZE. (5.3)
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
cha