Refractory Testicular Tumors

The recommended dose of ETOPOPHOS is:

• 50 to 100 mg/m2 per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5 of each 21-day (or 28-day cycle), or
• 100 mg/m2 administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5 of each 21-day (or 28-day cycle).

Small Cell Lung Cancer

The recommended dose of ETOPOPHOS is:

• 35 mg/m2 per day administered intravenously over 5 minutes to 3.5 hours for 4 days, or
• 50 mg/m2 per day administered intravenously over 5 minutes to 3.5 hours for 5 days.

Dosage Modification

In patients with a creatinine clearance (CLcr) 15-50 mL/min, administer 75% of the recommended dose.
Data are not available in patients with CLcr less than 15 mL/min. Consider further dose reduction in these patients.

Preparation and Administration

Preparation

• Reconstitute with Sterile Water for Injection, USP; 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; Bacteriostatic Water for Injection with Benzyl Alcohol; or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol, using the quantity of diluent shown below:

• Following reconstitution, ETOPOPHOS can be further diluted to concentrations as low as 0.1 mg/mL with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP.

• Inspect parenteral drug products visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Storage
After reconstitution, store under the following conditions:

• Refrigerated 2° to 8°C (36° to 46°F) for 7 days;

• Room temperature at 20° to 25°C (68° to 77°F) for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP;

• Room temperature 20° to 25°C (68° to 77°F) for 48 hours following reconstitution with Bacteriostatic Water for Injection with benzyl alcohol or Bacteriostatic Sodium Chloride for Injection with benzyl alcohol.

Reconstituted ETOPOPHOS solutions further diluted as directed can be stored under refrigeration 2° to 8°C (36° to 46°F) or at room temperature 20° to 25°C (68° to 77°F) for 24 hours.

Administration
DO NOT GIVE ETOPOPHOS BY BOLUS INTRAVENOUS INJECTION. ETOPOPHOS solutions may be administered at infusion rates up to 3.5 hours. Extravasation of ETOPOPHOS may result in swelling, pain, cellulitis, and necrosis including skin necrosis.

ETOPOPHOS is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 To minimize the risk of dermal exposure, use of gloves is recommended. If dermal contact occurs, immediately and thoroughly wash areas of skin contact with soap and water and flush mucosa with water.