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U.S. Department of Health and Human Services

Safety

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

Health professionals are notified of updated prescribing and treatment information regarding use of WinRho SDF™ (Rho(D) Immune Globulin Intravenous (Human)). Based on a recent assessment of adverse events following administration of WinRho to immune thrombocytopenic purpura (ITP) patients positive for Rho(D) antigen (D-positive), we have revised the package insert to state that "Rho(D) positive patients treated with WinRho SDF should be monitored for signs and/or symptoms of intravascular hemolysis (IVH), clinically compromising anemia, and renal insufficiency."

[January 7, 2000 - Letter - Cangene Corporation and Nabi]