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Drug Names(s): Immune Globulin Intravenous [Human]
Description: Rhophylac, an anti-D Rh immunoglobulin (Ig), is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution. Plasma is obtained from healthy Rh0(D)-negative donors who have been immunized with Rh0(D)-positive RBCs. The mechanism by which Rh0(D) immune globulin suppresses immunization to Rh0(D)-positive RBCs is not completely known. The mechanism of action is thought to involve the formation of Rh0(D) immune globulin RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.
Pink Sheet ZLB Rhophylac Clears FDA
Pink Sheet ZLB Rhophylac clears FDA
Pink Sheet Rhophylac warning letter
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