RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg), is a prescription medicine given by intramuscular injection that is used to prevent Rh immunization, a condition in which an individual with Rh-negative blood develops antibodies after exposure to Rh-positive blood. MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) is a lower dose of Rho(D) immune globulin that is used in certain clinical situations.
If the father or baby is not conclusively shown to be Rh-negative, RhoGAM should be given to a Rh-negative mother in the following clinical situations to prevent Rh immunization:
IMPORTANT SAFETY INFORMATION
RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive or if you have had a severe allergic reaction to human immune globulin.
Be sure to tell your healthcare provider about all your medical conditions, including:
Allergic reactions to RhoGAM or MICRhoGAM may occur. You should be observed for at least 20 minutes after administration. Signs and symptoms of an allergic reaction include itchy rash (hives/urticaria), tightness of the chest, wheezing, low blood pressure and anaphylaxis (which may also include throat or tongue swelling, shortness of breath, vomiting, hives and/or lightheadedness).
RhoGAM and MICRhoGAM are prepared from human plasma and may contain infectious agents that can cause disease. Numerous tests have been applied in the plasma collection process and specific viral inactivation steps have been added to the manufacturing process to minimize the risk of transmission of diseases, but all risk cannot be eliminated.
The most common side effects of RhoGAM and MICRhoGAM are swelling, hardening, redness, and mild pain at the site of the injection. A small number of patients have noted a slight fever.
Your healthcare provider should provide you with a completed Patient Identification Card for you to retain and present to other healthcare providers.
You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or
Click here for the RhoGAM and MicRhoGAM Full Prescribing Information.
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