Trisenox
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TRISENOX is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (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.
History
There is currently no drug history available for this drug.
Other Information
TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is As2O3, with a molecular weight of 197.8 and has the following structural formula:
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Sources
Trisenox Manufacturers
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Cephalon, Inc.
![Trisenox (Arsenic Trioxide) Injection, Solution [Cephalon, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Trisenox | Cephalon, Incorporated
2.1 Recommended DosageInduction Treatment Schedule: Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily until bone marrow remission. Do not exceed 60 doses for induction.
Consolidation Treatment Schedule: Begin consolidation treatment 3 to 6 weeks after completion of induction therapy. Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.
2.2 Dose Adjustment for Non-Hematologic Adverse ReactionsIf a severe non-hematologic adverse reaction occurs (such as neurologic or dermatologic toxicity), consider delaying TRISENOX infusion until the event has resolved (≤ Grade 1).
2.3 Instructions for Preparation and Intravenous AdministrationAdministration
Administer TRISENOX intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. A central venous catheter is not required.
The TRISENOX ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Do not mix TRISENOX with other medications.
Reconstitution
Dilute TRISENOX with 100 to 250 mL 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. Do not save any unused portions for later administration.
Safe Handling Procedures
TRISENOX is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
2.4 StabilityAfter dilution, TRISENOX is chemically and physically stable when stored for 24 hours at room temperature and 48 hours when refrigerated.
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