July 27, 2016
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Etopophos

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Etopophos




Indications
Dosage
How Supplied

INDICATIONS

ETOPOPHOS for Injection is indicated in the management of the following neoplasms:

Refractory Testicular Tumors - ETOPOPHOS for Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.

Small Cell Lung Cancer - ETOPOPHOS for Injection in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.

DOSAGE AND ADMINISTRATION

The usual dose of VePesid for Injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m²/day on days 1 through 5 to 100 mg/m²/day on days 1, 3, and 5. Equivalent doses of ETOPOPHOS should be used.

In small cell lung cancer, the VePesid for Injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m²/day for 4 days to 50 mg/m²/day for 5 days. Equivalent doses of ETOPOPHOS should be used.

For recommended dosing adjustments in patients with renal impairment, see PRECAUTIONS.

ETOPOPHOS SHOULD NOT BE GIVEN BY BOLUS INTRAVENOUS INJECTION. ETOPOPHOS solutions may be administered at infusion rates from 5 to 210 minutes. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.

The dosage should be modified to take into account the myelosuppressive effect of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.

Administration Precautions

As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of ETOPOPHOS. Skin reactions associated with accidental exposure to ETOPOPHOS may occur. The use of gloves is recommended. If ETOPOPHOS solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.

Preparation For Intravenous Administration

Prior to use, the content of each vial must be reconstituted 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 to a concentration equivalent to 20 mg/mL or 10 mg/mL etoposide (22.7 or 11.4 mg/mL etoposide 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 SUPPLIED

ETOPOPHOSR (etoposide phosphate) for Injection is supplied as individual cartoned vials 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

1. 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.

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/otm_vi_2.html

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

4. 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 60015 USA, Product of Germany. Distributed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Revised: July 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/11/2016

Indications
Dosage
How Supplied

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