Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)
Cephalon, LLC
ARSENIC TRIOXIDE - UNII:C96613F5AV)
ARSENIC TRIOXIDE 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
TRISENOX- ARSENIC TRIOXIDE INJECTION, SOLUTION CEPHALON, LLC ---------- 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 Olvassa el a teljes dokumentumot