What are the indications for RhoGAM (Rho(D) immune globulin)?

From the Guidelines

Indications for RhoGAM (Rho(D) immune globulin)

RhoGAM is indicated for prevention of RhD alloimmunization in RhD-negative individuals, particularly in the context of pregnancy, abortion, or other potential sensitizing events 1.

• The primary goal of RhoGAM administration is to prevent the formation of anti-D antibodies in RhD-negative individuals, which can lead to hemolytic disease of the newborn in future pregnancies.
• Specific indications for RhoGAM include:
  • Spontaneous or induced abortion at less than 12 weeks of gestation 1
  • Postpartum administration to RhD-negative mothers who deliver RhD-positive infants 1
  • Antepartum administration to RhD-negative pregnant women at risk of sensitization 1
• The recommended dose of RhoGAM for spontaneous or induced abortion at less than 12 weeks of gestation is 50 mg within 72 hours of the event, although a 300 mg dose may be used if the lower dose is unavailable 1.
• It is essential to note that while the risk of alloimmunization after early pregnancy loss or induced abortion may be low, it is not negligible, and prevention is critical to avoid devastating fetal and neonatal outcomes 1.

From the FDA Drug Label

INDICATIONS AND USAGE Pregnancy and Other Obstetric Conditions HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,(12) providing the following criteria are met: The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor. Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS). If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho(D) positive infant. If the father can be determined to be Rho(D) negative, HyperRHO S/D Full Dose need not be given HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmunized Rho(D) negative women who have undergone spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D) negative. (7,8) If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive,(2) and HyperRHO S/D Full Dose should be administered to the mother. Transfusion HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells.(5,13)

The indications for RhoGAM (Rho(D) immune globulin) are:

• Prevention of Rh hemolytic disease of the newborn in Rho(D) negative mothers who give birth to Rho(D) positive infants
• Prevention of isoimmunization in Rho(D) negative women who have undergone:
  • Spontaneous or induced abortion
  • Ruptured tubal pregnancy
  • Amniocentesis
  • Abdominal trauma
• Prevention of isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells 2

From the Research

Indications for RhoGAM (Rho(D) immune globulin)

The indications for RhoGAM (Rho(D) immune globulin) include:

• Prevention of Rh isoimmunization in Rh-negative women after delivery, abortion, or ectopic pregnancy 3
• Prevention of Rh isoimmunization in Rh-negative women at risk of fetomaternal hemorrhage during pregnancy 3, 4
• Administration after spontaneous or induced abortion, with recent studies indicating that forgoing Rh immunoglobulin administration before 12 weeks gestation is highly unlikely to increase risk of Rh (D) antibody development 5
• Administration after dilation and evacuation procedures up to 18 weeks gestation, with a dose of 100mcg of Rh immunoglobulin adequate to treat fetomaternal hemorrhage 5
• Treatment of massive fetomaternal hemorrhage, with dosing guidelines for Rho(D) immune globulin provided based on the volume of fetal blood in the maternal circulation 4

Special Considerations

• Women with molecularly defined weak D types 1,2,3,4.0, and 4.1 do not need RhIG as they are unlikely to produce alloanti-D when exposed to fetuses with D-positive red cells 6
• Women with Asian-type DEL (c.1227G>A) also do not form alloanti-D when exposed to D-positive red cells and do not require RhIG before and after delivery 6