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:
- After delivery of a Rh-positive baby.
- Routine prevention of Rh immunization at 26 to 28 weeks of pregnancy.
- Maternal or fetal bleeding during pregnancy from certain conditions.
- Actual or threatened pregnancy loss at any stage. MICRhoGAM should be used in Rh-negative women who experience pregnancy loss at or up to 12 weeks of pregnancy.
- Ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus).
RhoGAM or MICRhoGAM may also be used to prevent Rh immunization in Rh-negative patients after the incompatible transfusion of Rh-positive blood or blood products.
IMPORTANT SAFETY INFORMATION
RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive.
Be sure to tell your healthcare provider about all your medical conditions, including:
- If you have known severe allergic reactions or a severe response to human immune globulin.
- If you have experienced a serious reaction to other medicines that contain immune globulin.
- If you have an immunoglobulin A (IgA) deficiency. RhoGAM and MICRhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.
- Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immune globulin products, like RhoGAM or MICRhoGAM. The antibodies in RhoGAM and MICRhoGAM may prevent the vaccine from working. Before you get a vaccine, tell your healthcare provider that you have received RhoGAM or MICRhoGAM.
RhoGAM and MICRhoGAM are made from human blood and therefore, carry a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
Reactions to RhoGAM or MICRhoGAM that affect the entire body are extremely rare. However allergic responses to RhoGAM or MICRhoGAM may occur. You should be observed for at least 20 minutes after administration for early signs of an allergic reaction. Signs and symptoms of an allergic reaction include itchy rash (hives), 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).
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 call 1-800-FDA-1088.
Click here for the RhoGAM Full Prescribing Information
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