Rho(D) Immune Globulin (Human)

Revised March 4, 2019

Section 1.1

Rh (D) Immune Globulin (Human) (RhIg) is a solvent detergent treated, sterile, lyophilized gamma globulin (IgG) fraction of human plasma containing antibodies to the Rh(D) antigen. It prevents the development of Rh antibodies in the Rh(D) negative patient carrying a Rh(D) positive fetus, thus preventing the occurrence of haemolytic disease in the fetus or newborn.

Indications and Clinical Use:

Rh (D) Immune Globulin (Human) is indicated for the prevention of Rh immunization in Rh(D) negative patients during pregnancy, so long as they are not previously sensitized.

Rh (D) Immune Globulin (Human) should be offered to known Rh(D) negative patients:

  • At 28 weeks gestation;
  • Within 72 hours of the birth of a Rh(D) positive (including weak D) baby;
  • As soon as possible or within 72 hours of any complication or procedure that could result in a potential fetomaternal haemorrhage:
    • vaginal bleeding,
    • therapeutic or spontaneous abortion,
    • molar pregnancy,
    • ectopic pregnancy,
    • placental abruption,
    • abdominal trauma,
    • obstetrical procedures,
    • amniocentesis,
    • chorionic villi sampling (CVS),
    • percutaneous umbilical blood sampling,
    • external cephalic version (ECV); and
  • Every 12 weeks until delivery with ongoing vaginal bleeding.

Contraindications:

  • A history of anaphylactic or severe systemic reaction to the administration of human immune globulin products.
  • IgA deficiency with antibodies to IgA and a history of hypersensitivity.
  • Autoimmune hemolytic anemia, with pre-existing hemolysis or at high risk for hemolysis.
  • Rh(D)-positive.
  • Rh(D)-negative who are Rh(D) immunized by standard manual Rh antibody screening tests (after due allowance for previously administered anti-D immunoglobulin causing “false positive” test result).

Dosage and Administration:

  • Rh (D) Immune Globulin (Human) is available in 600 units (120 mcg) and 1500 units (300 mcg) and can be administered IM or IV.
  • Administer Rh (D) Immune Globulin (Human) separately from other therapeutics.
  • Administer IV Rh (D) Immune Globulin (Human) slowly over 3-5 minutes.
  • Dosage and route of administration may differ based fetal and maternal factors (contraindication to IM injection or large IM volume required). Dosage also differs based on how laboratories report the volume of fetomaternal hemorrhage: volume of fetal whole blood versus volume of fetal red cells.
  • The dosage guideline[1] is outlined in the table below.
IndicationIM RhIg Dosage
600 Units (120 mcg)1500 Units (300 mcg)
Complications: pregnancy before 12 weeks
Complications: pregnancy after 12 weeks
Prophylactic dose at 28 weeks
Obstetrical procedure: amniocentesis/ECV after 34 weeks
Every 12 weeks until delivery with ongoing vaginal bleeding
Within 72 hours after birth or as soon as possible of confirmed Rh(D) positive babyDosing may depend on local inventory; refer to local Health Authority policies and procedures
Massive fetomaternal haemorrhageConsult Transfusion Medicine Specialist
  • In the event of a massive fetal maternal hemorrhage:
    • consult with a transfusion medicine specialist for dosing recommendations;
    • Rh (D) Immune Globulin (Human) dose depends on the presence of fetal cells in the maternal circulation and may be reported as volume of whole blood cells or volume of red cells;
    • a Kleihauer-Betke or Flow cytometry test should be used to quantify the fetomaternal hemorrhage and individualize the appropriate dose;
    • Rh (D) Immune Globulin (Human) 90 units is recommended for each 1 mL of fetal blood in the maternal circulation;
    • where the volume of fetomaternal hemorrhage is unknown, administer 1500 units (300 mcg) IM or IV as soon as possible and within 72 hours of birth;
    • each antepartum hemorrhage should be treated as a separate incident with appropriate dose of anti-D immunoglobulin;
    • dosages may vary according to blood bank directives.

Pregnancy:

Compatible

Lactation:

Category L2– Limited Data – Probably Compatible

Adverse Reactions:

  • Side Effects are uncommon (<2%) Headache, chills, fever, asthenia, pallor, diarrhea, nausea, vomiting, arthralgia, myalgia, dizziness, malaise, hyperkinesia, abdominal or back pain, hypotension, hypertension, increase LDH, somnolence, vasodilation, pruritus, rash and sweating.
  • An allergic response is possible: there should be observation for at least 20 minutes after administration. Epinephrine and Diphenhydramine should be immediately available.

Warnings and Precautions:

  • Rh (D) Immune Globulin (Human) is made from human plasma; it may carry a risk of transmitting infectious agents, e.g., viruses.
  • The risks associated with administration of this blood product is very low, however, it is possible that screening may not detect all possible pathogens and this information should be provided to the woman before administration.
  • Risk of transmitting an infectious agent has been reduced by screening plasma donors, testing for the presence of certain prevalent viral infections, and including virus inactivation/removal steps in the manufacturing process.
  • The product has been specifically screened or processed to remove the risk of HIV, hepatitis A, B, and C, West Nile viruses, and human parvovirus B19.
  • The liquid formulation of Rh (D) Immune Globulin (Human) contains maltose. Maltose has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems.

For Women Eligible for MMR Vaccines Postpartum (identified as non-immune in pregnancy):

  • Rh (D) Immune Globulin (Human) may transiently impair the immune response to live attenuated virus vaccines such as MMR and varicella; delay immunization with live vaccines for three months after administration of Rh (D) Immune Globulin (Human) SDF .