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.
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.
Published Studies Related to Winrho SDF (Rho D Immune Globulin)
Anti-D (WinRho SD) treatment of children with chronic autoimmune thrombocytopenic purpura stimulates transient cytokine/chemokine production. [2002.03]
Intravenous anti-D is often used in the treatment of autoimmune thrombocytopenic purpura (AITP), but little is known about its mechanisms of action. To investigate anti-D's potential in vivo mechanism(s) of action, a small group (N = 7) of children with chronic AITP was studied...
Neurodevelopmental disorders, maternal Rh-negativity, and Rho(D) immune globulins: a multi-center assessment. [2008.04]
BACKGROUND: Many formulations of Thimerosal (49.55% mercury by weight)-containing Rho(D) immune globulins (TCRs) were routinely administered to Rh-negative mothers in the US prior to 2002. OBJECTIVES: It was hypothesized: (1) if prenatal Rho(D)-immune globulin preparation exposure was a risk factor for neurodevelopmental disorders (NDs) then more children with NDs would have Rh-negative mothers compared to controls; and (2) if Thimerosal in the Rho(D)-immune globulin preparations was the ingredient associated with NDs, following the removal of Thimerosal from all manufactured Rho(D)-immune globulin preparations from 2002 in the US the frequency of maternal Rh-negativity among children with NDs should be similar to control populations... CONCLUSION: This study associates TCR exposure with some NDs in children.
Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac) in chronic immune thrombocytopenic purpura. [2007.08]
OBJECTIVES: This Phase III study examined the efficacy and safety of Rhophylac (CSL Behring AG, Bern, Switzerland), a highly pure, liquid-stable anti-D preparation, in chronic immune thrombocytopenic purpura (ITP)... CONCLUSION: rhophylac is well tolerated and efficacious in chronic itp.
A prospective study of thimerosal-containing Rho(D)-immune globulin administration as a risk factor for autistic disorders. [2007.05]
BACKGROUND: This study evaluated the relationship between prenatal mercury exposure from thimerosal (49.55% mercury by weight)-containing Rho(D)-immune globulins (TCRs) and autism spectrum disorders (ASDs)... CONCLUSION: The results provide insights into the potential role prenatal mercury exposure may play in some children with ASDs.
Non-evidence-based use of Rho(D) immune globulin for threatened abortion by family practice and obstetric faculty physicians. [2002.11]
OBJECTIVE: To examine the practice patterns and differences between faculty members in obstetrics and gynecology (OB/G) and family practice (FP) residency programs in administering Rho(D) immune globulin (RhIG) for threatened abortion... CONCLUSION: Most FP and OB/G residency faculty report using RhIG in threatened abortion. The practice has become part of the medical culture despite the lack of supporting evidence and should be revaluated in that light.
Clinical Trials Related to Winrho SDF (Rho D Immune Globulin)
Role of Andi-d in Dengue Fever: a Pilot Study [Completed]
Reports of Suspected Winrho SDF (Rho D Immune Globulin) Side Effects
Haemoglobin Decreased (6),
Chest Pain (4),
Blood Lactate Dehydrogenase Increased (4),
Abdominal Pain (3), more >>
Page last updated: 2008-08-11