You’ve recently learned that you are “Rh-negative”, and therefore your baby may be at risk for hemolytic disease of the fetus and newborn, also known as HDFN. Before hearing the news from your doctor or nurse, no doubt your thoughts were filled with all the joyful anticipations of a new baby: picking out names, planning a nursery, buying infant clothes, and sharing sonogram images with relatives and friends. But now, unfamiliar terms such as Rh factor, antibodies, and HDFN may have you feeling concerned, even scared. Don’t be!
There is a treatment called RhoGAM® Brand that, if administered properly, can virtually eliminate the risk of HDFN; your doctor will be prescribing it for you. RhoGAM® Brand, a life saving miracle, was developed more than 40 years ago by Ortho-Clinical Diagnostics, the same company that today manufactures RhoGAM® and MICRhoGAM® Brands for Kedrion Biopharma.
Important Safety Information
RhoGAM® Brand is 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® Ultra-Filtered PLUS Rho(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.