Erbitux Label Update Includes Lengthened Observation For Infusion Reactions
This article was originally published in The Pink Sheet Daily
Executive Summary
Corresponding Bristol/ImClone “Dear Doctor” letter also describes new labeling language on severe electrolyte depletion observed in ongoing clinical trials of the colorectal cancer drug.
|
Bristol-Myers Squibb and ImClone are distributing a letter to doctors regarding longer observation periods for patients experiencing infusion reactions with the colorectal cancer drug Erbitux (cetuximab). Updated Erbitux labeling, approved Sept. 1, includes a revised Warnings section with the statement: "A 1-hour observation period is recommended following Erbitux infusion. Longer observation periods may be required in patients who experience infusion reactions." The statement on extended observation is repeated in the Dosage and Administration section. Erbitux has carried a "black box" warning on infusion reactions since its approval in February 2004 (1 (Also see "Bristol/ImClone's Erbitux Clears FDA; Undergoing Two Confirmatory Trials" - Pink Sheet, 12 Feb, 2004.)). A corresponding Sept. 13 "Dear Healthcare Provider" letter notes that the expanded labeling also addresses electrolyte depletion observed in Erbitux patients in ongoing clinical trials. "Approximately one-half of these patients receiving Erbitux experienced hypomagnesemia and 10%-15% experienced severe hypomagnesemia," the updated Adverse Reactions section of labeling states. "The onset of electrolyte abnormalities has been reported to occur from days to months after initiation of Erbitux. Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required." The Precautions section of labeling recommends periodic laboratory tests to monitor for hypomagnesemia during Erbitux therapy and for eight weeks after therapy completion. - Elizabeth Walker |