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WinRho® SDF is an Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients.
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, or
- 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
WinRho® SDF is indicated for the suppression of Rh isoimmunization in non-sensitized, Rho(D)-negative (D-negative) women with an Rh-incompatible pregnancy, including:
- 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.
There is currently no drug history available for this drug.
WinRho® SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen (D antigen). WinRho® SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization.
WinRho® SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and Triton® X-100) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a Planova™ 20N virus filter is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses.
The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 5.
|Anion Exchange Chromatography (partitioning)||Not evaluated||2.3||n.e.||3.4||n.e.|
|20N Filtration (size exclusion)||≥ 4.7||≥ 3.5||≥ 5.6*||n.e.||4.8||n.e.||4.1|
|Solvent/Detergent (inactivation)||≥ 4.7||≥ 7.3||≥ 5.5||Not evaluated|
|Total Reduction (log10)||≥ 9.4||≥ 10.8||≥ 11.1||7.1||7.5|
* The PRV was retained by the 0.1 µm pre-filter during the virus validation. Since manufacturing employs a 0.1 µm pre-filter before the 20N filter, the claim of ≥5.6 reduction is considered applicable.
HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2.
BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV)
PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes
HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general
EMC: encephalomyocarditis virus; model for HAV and for small non-enveloped viruses in general
MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general
PPV: porcine parvovirus; model for human parvovirus B19 and for small non-enveloped viruses in general
n.e.: not evaluated
The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rho(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram” dose. Potency and dosing recommendations are now expressed in international units by comparison to the WHO anti-Rho(D) standard. The conversion of “microgram” to “international units” is: 1 microgram = 5 international units. A 1,500 international unit (300 microgram [mcg]) vial contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of approximately 17 mL of Rho(D) (D-positive) RBCs.
The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho® SDF does not contain mercury. This product contains approximately 5 micrograms/mL IgA.