Treatment of ITP:
WinRho® SDF is indicated for use 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 and
- children and adults with ITP secondary to HIV infection
The safety and efficacy of WinRho® SDF 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.
Pregnancy and Other Obstetric Conditions:
- Routine antepartum and postpartum Rh prophylaxis
- Rh prophylaxis in cases of:
_ Obstetric complication (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplancental hemorrhage resulting from antepartum hemorrhage)
_ Invasive procedures during pregnancy (e.g., amniocentesis,chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)
An Rh-incompatible pregnancy is assumed if the fetus/baby is either Rho(D)-positive or Rho(D)-unknown or if the father is either Rho(D)-positive or Rho(D)-unknown.
WinRho® SDF is indicated for the suppression of Rh isoimmunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs.
WinRho® SDF is not indicated for use as immunoglobulin replacement therapy for immune globulin deficiency syndromes.
For indications, dosing and other information, please refer to the prescribing information.