VePesid (etoposide) is indicated in the management of the following neoplasms:

Refractory Testicular Tumors:   VePesid 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.

Adequate data on the use of VePesid Capsules in the treatment of testicular cancer are not available.

Small Cell Lung Cancer:   VePesid For Injection and/or Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with undiluted VePesid For Injection.

VePesid For Injection:   The usual dose of VePesid For Injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m ² /day on days 1 through 5 to 100 mg/m ² /day on days 1, 3, and 5.

In small cell lung cancer, the VePesid For Injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m ² /day for 4 days to 50 mg/m ² /day for 5 days.

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

Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.

VePesid (etoposide) Capsules:   In small cell lung cancer, the recommended dose of VePesid Capsules is two times the I.V. dose rounded to the nearest 50 mg.

The dosage, by either route, should be modified to take into account the myelosuppressive effects 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 VePesid. Skin reactions associated with accidental exposure to VePesid may occur. The use of gloves is recommended. If VePesid 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:   VePesid For Injection must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the VePesid solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. VePesid should not be given by rapid intravenous injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration (see

DESCRIPTION

Stability:   Unopened vials of VePesid For Injection are stable for 24 months at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 or 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.

VePesid Capsules must be stored under refrigeration 2°-8°C (36°- 46°F). The capsules are stable for 24 months under such refrigeration conditions.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. ^4-10 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

VePesid® (etoposide) For Injection

NDC 0015-3095-20 - 100 mg/5 mL Sterile, Multiple Dose Vial, 10's

NDC 0015-3084-20 - 150 mg/7.5 mL Sterile, Multiple Dose Vial

NDC 0015-3061-20 - 500 mg/25 mL Sterile, Multiple Dose Vial

NDC 0015-3062-20 - 1 gram/50 mL Sterile, Multiple Dose Vial

VePesid® (etoposide) Capsules

NDC 0015-3091-45 - 50 mg pink capsules with "BRISTOL 3091" printed in black in blisterpacks of 20 individually labeled blisters, each containing one capsule.

Capsules are to be stored under refrigeration 2°-8°C (36°-46°F).

DO NOT FREEZE.

Dispense in child-resistant containers.

For information on package sizes available, refer to the current price schedule.

REFERENCES

1. Gaver RC, Deeb G: The Effect of Other Drugs on the in vitro Binding of 14C-Etoposide to Human Serum Proteins. Proc Am Assoc Cancer Res 1989; 30:A2132.
2. Stewart CF, et al: Altered Protein Binding of Etoposide in Patients with Cancer. Clin Pharmacol Ther 1989; 45:49-55.
3. Stewart CF, et al: Prospective Evaluation of a Model for Predicting Etoposide Plasma Protein Binding in Cancer Patients. Proc Am Assoc Cancer Res 1989; 30:A958.
4. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
5. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253(11):1590-1592.
6. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
7. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.
8. Jones RB, et al: Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians 1983; (Sept/Oct)258-263.
9. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049.
10. Controlling Occupational Exposure to Hazardous Drugs. (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996; 53:1669-1685.

Capsules:

Manufactured by:

R.P. Scherer GmbH

Eberback/Baden, Germany

Injection:

BRISTOL LABORATORIES

Oncology Products

A Bristol-Myers Squibb Co.

Princeton, New Jersey 08543 U.S.A.

Distributed by:

BRISTOL LABORATORIES®

ONCOLOGY PRODUCTS

A Bristol-Myers Squibb Company

Princeton, NJ 08543

U.S.A.

Bookmark this page: