Common Questions

What is WinRho® SDF?

WinRho® SDF [Rh_o(D) Immune Globulin Intravenous (Human)] is a purified human immunoglobulin used to treat immune thrombocytopenic purpura or 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, Rh_o(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 Rh_o(D) negative.

WinRho® SDF should not be administered to:

• Rh-negative patients
• splenectomized patients

WinRho® SDF works by increasing levels of platelets and therefore alleviating symptoms of ITP such as bleeding and bruising.

When did WinRho® SDF become available?

WinRho® SDF was licensed by the FDA in 1995 as the first Anti-D therapy in the world indicated for the treatment of ITP. Baxter became the sole distributor of WinRho® SDF in the US in 2005.

WinRho® SDF has been licensed since 1980 in Canada for treatment of Hemolytic Disease of Newborn (HDN).

How is WinRho® SDF prepared?

WinRho® SDF is manufactured using source plasma, collected at FDA licensed plasma centers. Each donor’s plasma is rigorously screened and tested for HIV, hepatitis B and hepatitis C. Nucleic acid testing (NAT) is also used to screen plasma minipools for HBV, HCV, HIV, hepatitis A, and B19 Parvovirus.

Cangene Corporation, which manufactures the therapy, uses many processing safety steps, including anion-exchange chromatography, solvent/detergent treatment, and nanofiltration.

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.

How is WinRho® SDF administered?

WinRho® SDF therapy is given intravenously at either a doctor's office, a hospital outpatient setting, or at home; administration usually takes 3-5 minutes. Your physician can order laboratory tests to determine the frequency of therapy.

How quickly does WinRho® SDF work?

Platelet levels usually increase within 1-2 days, and peak within 7-14 days. Each dose can last approximately 30 days, although it can vary from patient to patient.

How long does the response to WinRho® SDF last?

Response duration varies according to treatment groups but has been shown to reach almost 90 days in adults with chronic ITP.¹

Does WinRho® SDF have any side effects?

In clinical studies, about 7% of all WinRho® SDF infusions results in adverse effects. The most common ones included headache, chills, and fever.

I’d like to learn more about WinRho® SDF. How can I get more information?

Please call 1-800-4WINRHO (1-800-494-6746).

Please see Important Safety Information and Prescribing Information.