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Trisenox

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Trisenox




Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Recommended Dosage

Induction 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.

Dose Adjustment For Non-Hematologic Adverse Reactions

If a severe non-hematologic adverse reaction occurs (such as neurologic or dermatologic toxicity), consider delaying TRISENOX infusion until the event has resolved ( ≤ Grade 1).

Instructions For Preparation And Intravenous Administration
Administration

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

Stability

After dilution, TRISENOX is chemically and physically stable when stored for 24 hours at room temperature and 48 hours when refrigerated.

HOW SUPPLIED

Dosage Forms And Strengths

TRISENOX is an injectable solution for intravenous administration supplied as 10mg /10 ml of arsenic trioxide in single-use ampules.

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.

Storage And Handling

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

REFERENCES

1. “Hazardous Drugs”, OSHA. [Accessed on February 12, 2015 from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised: Feb 2015

Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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