WinRho® SDF

Manufacturer: Baxter Healthcare
Generic Name: Immune Globulin; Rho(D) Immune Globulin

Indications:
Treatment of ITP
WinRho® SDF must be administered via the intravenous route when used in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in 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
  

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 or in patients who are Rho(D) negative.

Suppression of Rh Isoimmunization
Pregnancy and Other Obstetric Conditions WinRho® SDF may be administered by either intramuscular injection or intravenously. WinRho® SDF is indicated 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. WinRho® SDF should not be administered to infants born to Rh incompatible mothers. The criteria for an Rh-incompatible pregnancy requiring administration of WinRho® SDF at 28 weeks gestation and within 72 hours after delivery in an Rho(D) negative mother are:

• 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 1,500 IU (300 μg) dose will suppress the immunizing potential of approximately 17 mL of Rho(D) positive RBCs.

WinRho® SDF, Rho(D) Immune Globulin Intravenous (Human), is not indicated for use as immunoglobulin replacement therapy for immune globulin deficiency syndromes. It should not be used for the treatment of ITP in Rho(D) negative or splenectomized individuals; efficacy in these patients has not been demonstrated.

WinRho® SDF Product Insert

How Supplied: 120 mcg vial, 300 mcg vial and 1000 mcg vial.

http://www.winrho.com/