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U.S. Department of Health and Human Services

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WinRho SDF (Rho(D) Immune Globulin Intravenous [Human])

Audience: Hematologists and other healthcare professionals

[Posted 01/06/2006] Cangene, Baxter Healthcare and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) to address two important safety concerns.

1] Continued postmarketing safety surveillance has shown rare, but severe and sometimes fatal, intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation in patients with ITP. Physicians should discuss the risks and benefits of WinRho SDF, alert patients who are being treated for ITP about the signs and symptoms associated with intravascular hemolysis (back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath) and advise patients to report any symptoms immediately to their physicians.

2] Maltose in IVIG products, such as the liquid formulation of WinRho SDF, has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving this product.

[December 09, 2005 - Dear Healthcare Professional Letter - Cangene/Baxter Healthcare]

[December 2005 - Patient Information - Cangene/Baxter Healthcare]

Previous FDA/MedWatch alerts
[November 09, 2005 - Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products ]
[November 09, 2005 - Important Safety Information - FDA/CBER]