toposide phosphate, respectively). Use the quantity of diluent shown below to reconstitute the product.
Vial Strength Volume of Diluent Final Concentration
100 mg 5 mL 20 mg/mL
10 mL 10 mg/mL
Following reconstitution, Etopophos can be further diluted to concentrations as low as 0.1 mg/mL etoposide with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
Solutions of Etopophos should be prepared in an aseptic manner. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Stability
Unopened vials of Etopophos for Injection are stable until the date indicated on the package when stored under refrigeration 2° to 8°C (36°-46°F) in the original package. When reconstituted as directed, Etopophos solutions can be stored in glass or plastic containers under refrigeration 2° to 8°C (36°-46°F) for 7 days; at controlled room temperature 20° to 25°C (68°-77°F) for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP; or at controlled room temperature 20° to 25°C (68°-77°F) for 48 hours following reconstitution with Bacteriostatic Water for Injection with Benzyl Alcohol or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol. Etopophos solutions further diluted as directed can be stored under refrigeration 2° to 8°C (36°-46°F) or at controlled room temperature 20° to 25°C (68°-77°F) for 24 hours.
How is Etopophos Supplied
Etopophos® (etoposide phosphate) for Injection is supplied as individual cartoned vials with white flip-off seals containing etoposide phosphate equivalent to 100 mg etoposide:
NDC 0015-3404-20 100 mg single-dose vial
Storage
Store the unopened vials under refrigeration 2° to 8°C (36°-46°F). Retain in original package to protect from light.
Handling and Disposal
Caution should be exercised when handling Etopophos for Injection. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4
To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Etopophos for Injection. More information is available in the references listed below.
REFERENCES
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
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/otm_vi_2.html
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60
