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Vepesid (Etoposide) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Laboratory Tests

Periodic complete blood counts should be done during the course of VePesid treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of VePesid.

Renal Impairment

In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:

Measured Creatinine Clearance>50 mL/min15-50 mL/min
etoposide100% of dose75% of dose

Subsequent VePesid dosing should be based on patient tolerance and clinical effect.

Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients.

Carcinogenesis (see WARNINGS), Mutagenesis, Impairment of Fertility

Etoposide has been shown to be mutagenic in Ames assay.

Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of VePesid on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected.

Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis).

Pregnancy

Pregnancy Category D

See WARNINGS.

OVERDOSAGE

No proven antidotes have been established for VePesid overdosage.

CONTRAINDICATIONS

VePesid is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

References

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
  2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621.
  3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1592.
  4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. 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, MA 02115.
  5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. 1983;1:426-428.
  6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258-263.
  7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
  8. Controlling occupational exposure to hazardous drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.

Manufactured by:
R.P. Scherer GmbH
Eberback/Baden, Germany
Distributed by:


Princeton, New Jersey 08543 USA

1082002A2
51-030187-01
Revised July 2006

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