WINRHO SDF SUMMARY
Rho(D) Immune Globulin Intravenous (Human) (Rho(D) IGIV) - WinRho SDF® - is a sterile, freeze-dried gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen (D antigen).
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is indicated for the following:
Treatment of ITP
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is recommended for the treatment of non-splenectomized, Rho(D) positive
-
children with chronic or acute ITP,
-
adults with chronic ITP, or
-
children and adults with ITP secondary to HIV infection
in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage. The safety and efficacy of WinRho have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients.
Suppression of Rh Isoimmunization
PREGNANCY AND OTHER OBSTETRIC CONDITIONS
WinRho SDF® is recommended for the suppression of Rh isoimmunization in non-sensitized, Rho(D) negative (D-negative) women within 72 hours after spontaneous or induced abortions, amniocentesis, chorionic villus sampling, ruptured tubal pregnancy, abdominal trauma or transplacental hemorrhage or in the normal course of pregnancy unless the blood type of the fetus or father is known to be Rho(D) negative. In the case of maternal bleeding due to threatened abortion, WinRho SDF® should be administered as soon as possible. Suppression of Rh isoimmunization reduces the likelihood of hemolytic disease in an Rho(D) positive fetus in present and future pregnancies.
The criteria for an Rh-incompatible pregnancy requiring administration of WinRho SDF® at 28 weeks gestation and within 72 hours after delivery are:
-
the mother must be Rho(D) negative,
-
the mother is carrying a child whose father is either Rho(D) positive or Rho(D) unknown,
-
the baby is either Rho(D) positive or Rho(D) unknown, and
-
the mother must not be previously sensitized to the Rho(D) factor.
TRANSFUSION
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is recommended for the suppression of Rh isoimmunization in Rho(D) negative female children and female adults in their childbearing years transfused with Rho(D) positive RBCs or blood components containing Rho(D) positive RBCs. Treatment should be initiated within 72 hours of exposure. Treatment should be given (without preceding exchange transfusion) only if the transfused Rho(D) positive blood represents less than 20% of the total circulating red cells. A 300 µg (1,500 IU) dose will suppress the immunizing potential of approximately 17 mL of Rho(D) positive RBCs.
|
