Rho(D) Immune Globulin (Human) (WinRho® SDF)

Section 1.1

See Protocol on Rho(D) sensitisation.

Indications and Clinical Use:

Should be offered to all eligible who are pregnant and Rho(D) negative for the purpose of preventing Rho(D) Isoimmunization.

Fetal erythrocytes are present >30 days after conception. Fetomaternal hemorrhage occurs in 75% of pregnancies. Maternal antibody response can be stimulated with as little as 0.1 mL of a fetomaternal transfusion (Wagle, 2011). If untreated, the incidence of Rho(D) alloimmunization with pregnancy loss

Prophylaxis should be offered:

  • At 28 weeks gestation and after the birth of a Rho(D) positive baby.
  • As soon as possible and within 72 hours of a potential fetomaternal transfusion:
    • any bleeding associated with threatened abortion,
    • therapeutic or spontaneous abortion,
    • molar pregnancy,
    • ectopic pregnancy,
    • abruption,
    • abdominal trauma,
    • obstetrical procedures,
    • amniocentesis,
    • Chorionic Villi Sampling (CVS),
    • percutaneous umbilical blood sampling,
    • External Cephalic Version (ECV).

Criteria:

only Rho(D) negative pregnancies where:

  • the paternal/genetic donor is either Rho(D) positive or Rho(D) unknown (paternity is uncertain in 3-5% of all pregnancies)
  • the fetus is either Rho(D) positive or Rho(D) unknown, and
  • there is no sensitization to the Rho(D) factor.
  • There has been an informed consent process. Some institutions require written consent.

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.
  • Rho(D)-positive.
  • Rho(D)-negative who are Rho(D) immunized by standard manual Rh antibody screening tests (after due allowance for previously administered anti-D immunoglobulin).

Dosage and Administration:

    • WinRho® SDF is available in 600 units and 1500 units and can be administered IM or IV.
    • Administer WinRho® SDF separately from other drugs.
    • Administer IV WinRho® SDF slowly over 3-5 minutes.
    • The dose guideline is outlined in the table below.
      • The dose is dependent upon the gestational age and the quantified fetomaternal transfusion (with Kleihauer-Betke).
      • In the event of a massive fetomaternal hemorrhage, WinRho® SDF 90 units is recommended for each 1 mL of fetal blood in the maternal circulation.

Where the volume of fetomaternal transfusion is not available administer 1500 units (300 mcg) IM or IV as soon as possible and within 72 hours of birth.

IndicationRho(D) IG Dosage*
600 Units
(120 mcg)
1500 Units
(300 mcg)
At 28 weeks gestation
After spontaneous or therapeutic abortion, or termination of ectopic
Threatened abortion at any time
Amniocentesis, cordocentesis, CVS, prior to 34 weeks
Amniocentesis, ECV after 34 weeks
Antepartum hemorrhage, abdominal trauma
Massive fetomaternal hemorrhage90 units/1 mL fetal blood
Within 72 hours after birth of confirmed Rho(D) positive baby
  • Dose depends on the presence of fetal cells in the maternal circulation. A positive Rosette test is followed by a Kleihauer-Betke to quantify the fetomaternal hemorrhage and individualize the appropriate dose.
  • 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:

No available data

Lactation:

Category L2

Adverse Reactions:

  • Side Effects are uncommon (<2%) Headache, chills, fever, asthenia, pallor, diarrhoea, 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:

  • WinRho® SDF is made from human plasma; it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Risk of transmitting an infectious agent has been reduced by screening plasma donors, testing for the presence of certain current viral infections, and including virus inactivation/removal steps in the manufacturing process.
  • The product has been screened or processed to remove the risk of HIV, hepatitis A, B, and C, West Nile viruses, and human parvovirus B19.
  • The risk 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.
  • Interference with Blood Glucose Testing: False High Blood Glucose Levels – The liquid formulation of WinRho® SDF contains maltose. Maltose has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems.

Live Virus Vaccines

  • WinRho® may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, rubella, and varicella. Delay immunization with live vaccines until >3 months after administration of WinRho®