TRISENOX (arsenic trioxide injection) 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.

The response rate of other acute myelogenous leukemia subtypes to TRISENOX (arsenic trioxide injection) has not been examined.

TRISENOX (arsenic trioxide injection) should be diluted 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. The TRISENOX (arsenic trioxide injection) ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Do not save any unused portions for later administration. Do not mix TRISENOX (arsenic trioxide injection) with other medications.

TRISENOX (arsenic trioxide injection) should be administered 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.

Stability

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

Dosing Regimen

TRISENOX (arsenic trioxide injection) is recommended to be given according to the following schedule:

Induction Treatment Schedule: TRISENOX (arsenic trioxide injection) should be administered intravenously at a dose of 0.15 mg/kg daily until bone marrow remission. Total induction dose should not exceed 60 doses.

Consolidation Treatment Schedule: Consolidation treatment should begin 3 to 6 weeks after completion of induction therapy. TRISENOX (arsenic trioxide injection) should be administered intravenously at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.

Handling And Disposal

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1"4 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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 often ampules.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). Do not freeze. Do not use beyond expiration date printed on the label.

REFERENCES

1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004:165.

2. OSHA Technical Manual. TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm vi 2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am JHealth-SystPharm. 2006; 63:1172-1193.

4. Polovich, M., White, J.M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) Pittsburgh, PA: Oncology Nursing Society

Manufactured for: Cephalon, Inc. Frazer, PA 19355. Revised June 2010

Last reviewed on RxList: 8/13/2010
This monograph has been modified to include the generic and brand name in many instances.