Description
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RhoGAM
Ultra-Filtered PLUS (RhoGAM) and MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) safely and effectively.
See full prescribing information for RhoGAM and MICRhoGAM.
• Rho(D) Immune Globulin (Human)
RhoGAM® Ultra-Filtered PLUS (300 μg) (1500 IU) Initial U.S. Approval: 1968
• Rho(D) Immune Globulin (Human)
MICRhoGAM® Ultra-Filtered PLUS (50 μg) (250 IU) Initial U.S. Approval: 1979
INDICATIONS AND USAGE
For use in preventing Rh immunization.
• Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are
conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the
mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened
pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1)
• Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive
blood or blood products (1.2)
DOSAGE AND ADMINISTRATION
For intramuscular use only, do not administer intravenously. Pregnancy and other obstetrical conditions
(2.1)
RhoGAM (300 μg) (1500 IU)
• Postpartum – if the newborn is Rh-positive. Administer within 72 hours of delivery.
• Antepartum –
• Prophylaxis at 26 – 28 weeks gestation.
• At or beyond thirteen weeks gestation: administer within 72 hours when suspected or proven exposure
to Rh-positive red blood cells occurs resulting from invasive procedures, abdominal trauma or obstetrical
manipulation, ectopic pregnancy, pregnancy termination or threatened termination.
Administer every 12 weeks starting from first injection to maintain a level of passively acquired
anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be
withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to > 15
mL of red blood cells has occurred.
MICRhoGAM (50 μg) (250 IU)
Administer within 72 hours of actual or threatened termination of pregnancy (spontaneous or induced) up
to and including 12 weeks gestation.
Transfusion of Rh-incompatible blood or blood products (2.1)
Administer within 72 hours. RhoGAM (300 μg) (1500 IU)
• 2.5 – 15.0 mL Rh-positive red blood cells
• > 15.0 mL Rh-positive red blood cells (multiple syringes) MICRhoGAM (50 μg) (250 IU)
• < 2.5 mL Rh-positive red blood cells
DOSAGE FORMS AND STRENGTHS Rho(D)
Immune Globulin (Human)
• RhoGAM® Ultra-Filtered PLUS – 300 μg (1500 IU) – Prefilled Syringes (3)
• MICRhoGAM® Ultra-Filtered PLUS – 50 μg (250 IU) – Prefilled Syringes (3)