Indications

RhoGAM is indicated for the prevention of Rh-sensitization in the following situations:

Pregnancy and other obstetrical conditions:

For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.

  • Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
  • Antepartum prophylaxis at 26 to 28 weeks gestation
  • Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
  • Actual or threatened pregnancy loss at any stage of gestation
  • Ectopic pregnancy

Please note, RhoGAM is intended for maternal use only and should not be administered to the newborn infant.

Transfusion of Rh-incompatible blood or blood products:

  • Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)

Click here for the RhoGAM Full Prescribing Information for complete list of indications & recommended dosing schedules.

 

Important Safety Information

RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are 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® 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.

RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. 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.

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

This site is intended for residents of the US only.

 

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