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Cangene, Baxter add boxed warning to WinRho SDF for immune thrombocytopenic purpura indication
Wednesday, March 10 2010 | Comments
What's This?
Cangene Corp. and Baxter Healthcare Corp. sent a letter to health care professionals informing them of the addition of a boxed warning to the product labeling for WinRho SDF (Rho[D] immune globulin intravenous [human]).The companies, in conjunction with the Food and Drug Administration, said cases of intravascular hemolysis and its complications have been reported with WinRho SDF among patients being treated for immune thrombocytopenic purpura (ITP). Some of these cases have resulted in death, most commonly among patients aged older than 65 years who have comorbid conditions.
The boxed warning, which applies to the ITP indication, emphasizes close monitoring of patients in a health care setting during the eight hours following WinRho SDF dosing and directs clinicians to perform a dipstick urinalysis at baseline and at two and four hours after administration of the drug and again before the end of the monitoring period, according to the FDA.
Beyond the initial monitoring period, patients should be instructed to be mindful of intravascular hemolysis symptoms, such as back pain, shaking chills, fever and discolored urine or hematuria. The warning outlines several laboratory tests that should be conducted in the event that intravascular hemolysis is suspected after WinRho SDF treatment.
Cangene and Baxter noted that its letter warning health care professionals of these developments does not apply to patients being treated with WinRho SDF for the suppression of Rh isoimmunization, another of its approved indications.
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