FDA Informs the Public of Potentially Significant Impurity in Cubicin Stored In ReadyMED Pumps

Cubist Pharmaceuticals, Inc. (Cubist) would like to inform you of important new safety information pertaining to CUBICIN® (daptomycin for injection) compatibility with ReadyMED® elastomeric infusion pumps manufactured by Cardinal Health, Inc. A potentially significant impurity, 2mercaptobenzothiazole (MBT), has been isolated from reconstituted CUBICIN stored in ReadyMED pumps.

At this time, Cubist recommends against using ReadyMED elastomeric infusion pumps with CUBICIN until this issue has been addressed. Further information regarding this issue is described below.

Laboratory investigations conducted by Cubist have examined the stability of daptomycin, reconstituted in 0.9% sodium chloride for injection USP and stored in ReadyMED and Eclipse® (I-Flow Corporation) elastomeric infusion pumps, at a concentration of 20 mg/mL for at least 10 days under refrigerated (5ºC) conditions.

Results demonstrated acceptable CUBICIN stability up to and including the 10th day in the control samples as well as samples from both pumps. However, MBT was detected in samples from the ReadyMED pumps.

MBT was not detected in samples from the Eclipse pumps or control samples. The clinical significance of this finding is unknown.

MBT is used in the manufacture of rubber as an accelerant in the vulcanization process. Human, non-occupational environmental exposure to low levels of MBT can occur through direct contact with rubber products and through consumption of water in contact with rubber plumbing products.

MBT has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. Cardinal Health, Inc. has been made aware of the findings.

Cubist has not evaluated the stability of reconstituted CUBICIN in elastomeric infusion pumps other than ReadyMED and Eclipse. No MBT has been identified in reconstituted CUBICIN in other standard types of infusion systems that have been tested.

Cubist is committed to ensuring that CUBICIN is used safely and effectively. A copy of the current CUBICIN package insert has been enclosed for your convenience. Should you have any questions or concerns regarding this safety information, please contact Cubist Drug Information at 866RXDAPTO (866-793-2786).

signature: William J. Martone, M.D.

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