Important Safety Information

RhoGAM^® and MICRhoGAM^® Ultra-Filtered PLUS Rh_o(D) Immune Globulin (Human) are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM^® and MICRhoGAM^® are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM^® and MICRhoGAM^® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM^® and MICRhoGAM^® for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.