Rho (D) Immune Globulin (Human) (WinRho® SDF) is a sterile lyophilized gamma globulin (IgG) fraction of human plasma containing antibodies to the Rho(D) antigen. It prevents the development of Rh antibodies in the Rho(D) negative patient carrying an Rho(D) positive fetus, thus preventing the occurrence of haemolytic disease in the fetus or newborn.
Indications and Clinical Use:
WinRho® SDF is indicated for the prevention of Rh immunization in Rho(D) negative patients during pregnancy, so long as they are not previously sensitized.
WinRho® SDF should be offered to known Rho(D) negative patients:
- At 28 weeks gestation;
- Within 72 hours of the birth of a Rho(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 hemmorhage:
- vaginal bleeding,
- therapeutic or spontaneous abortion,
- molar pregnancy,
- ectopic pregnancy,
- placental abruption,
- abdominal trauma,
- obstetrical procedures,
- chorionic villi sampling (CVS),
- percutaneous umbilical blood sampling,
- external cephalic version (ECV); and
- Every 12 weeks until delivery with ongoing vaginal bleeding.
- 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)-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 dosage guideline is outlined in the table below.
- In the event of a massive fetal maternal hemorrhage:
- consult with a transfusion medicine specialist;
- WinRho® SDF dose depends on the presence of fetal cells in the maternal circulation;
- a Kleihauer-Betke test should be used to quantify the fetomaternal hemorrhage and individualize the appropriate dose;
- WinRho® SDF 90 units is recommended for each 1 mL of fetal blood in the maternal circulation;
- where the volume of fetomaternal hemmorhage is not available, 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.
|Indication||Rho(D) IG Dosage|
IM or IV
|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||√|
|Massive fetomaternal hemorrhage||90 units/1 mL fetal blood|
|Every 12 weeks until delivery with ongoing vaginal bleeding||√|
|Within 72 hours after birth or as soon as possible of confirmed Rh(D) positive baby||√|
Category L2– Limited Data – Probably Compatible
- 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. Epinephrineand 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.
- 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.
For Women Eligible for MMR Vaccines Postpartum (identified as non-immune in pregnancy):
- WinRho® SDF 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 WinRho® SDF.