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Quinupristin/ Dalfopristin (warning removed)

Indication

  • One of this agent's approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia.
  • This agent has been approved for marketing in the United States for this indication under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.
  • Approval of this indication is based upon thi agent's ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker. However, a study to verify the clinical benefit of therapy with this drug on traditional clinical endpoints (such as cure of the underlying infection) is presently underway.

 


Package Inserts

Quinupristin

Dalfopristin

Additional Information

Updated January 2018