Important Safety Information
RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are indicated for the prevention of Rh immunization, including during and after pregnancy and other obstetrical conditions or incompatible transfusion of Rh-positive blood.
RhoGAM® and MICRhoGAM® 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.
RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. 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.
You are encouraged to report adverse events of prescription drugs to the FDA.
Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.
Click here for the RhoGAM Full Prescribing Information
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