Viral Safety
WinRho® SDF is made from the antibodies of carefully selected plasma donors. Precautions are taken to screen and test these donors and their plasma for potentially infectious agents such as viruses. Any donor or donation that does not fully meet the current safety standards is rejected.
- In addition to these precautions, WinRho® SDF processing includes: a solvent detergent step that destroys viruses such as HIV, hepatitis B (HBV), and hepatitis C (HCV).
- A 20nm viral filtration step, which has been shown to be effective in the removal of viruses such as hepatitis A and B19 parvovirus.
The potential to transmit viruses through blood products cannot be totally eliminated; however, the many precautions taken in the processing of WinRho® SDF ensure that such risks are dramatically reduced.
Indications and Usage1
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.
WinRho® SDF should not be administered to:
- Rho(D) negative patients
- splenectomized patients
Please review the Full Prescribing Information and Important Safety Information.
- WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)] package insert, Cangene Corporation,Winnipeg, Canada. Baxter Healthcare Corporation, Westlake Village, CA, USA, April 2006.
- Cines DB, Bussel JB. How I treat idiopathic thrombocytopenic purpura (ITP). Blood. 2005; 106: 2244-2251.
