Rhophylac Important Safety Information
WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh (D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh (D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh (D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration.
Please see Important Safety Information for Rhophylac and full Prescribing Information including boxed Warning.