Treatment of ITP
Since 1995, physicians have been using WinRho [Rho(D) Immune Globulin Intravenous (Human)] 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 immune thrombocytopenic purpura (ITP)
• adults with chronic ITP, or
• children and adults with ITP secondary to HIV infection.
The safety and efficacy of WinRho SDF has 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 [Rho(D) Immune Globulin Intravenous (Human)] has always been manufactured by Cangene Corporation, but until recently other companies distributed it. We are proud to announce that Cangene bioPharma, Inc. has now taken over the distribution of WinRho SDF. Over the next few months, we will be updating this site to provide comprehensive information on acute and chronic ITP, as well as its treatment.WinRho SDF Liquid is Bioequivalent to WinRho SDF Lyophilized1
In two comparative pharmacokinetic studies, 101 volunteers were administered the liquid or lyophilized formulation of WinRho SDF intravenously (N=41) or intramuscularly (N=60). The formulations were bioequivalent following IV administration based on area under the curve to 84 days and had comparable pharmacokinetics following IM administration. The average peak concentrations (Cmax) of anti-Rho(D) for both formulations were comparable following IV or IM administration and occurred within 30 minutes or 2-4 days of administration, respectively. Both formulations also had similar elimination half-lives (t ½) following IV or IM administration. WinRho SDF must be administered via the intravenous route for the treatment of ITP.
WARNING: INTRAVASCULAR HEMOLYSIS (IVH)
Intravascular hemolysis (IVH) leading to death has been reported in patients treated with WinRho® SDF for immune thrombocytopenic purpura (ITP).
IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
Closely monitor patients treated with WinRho® SDF for ITP in a healthcare setting for at least eight hours after administration. A dipstick urinalysis to monitor for hematuria and hemoglobinuria is to be performed at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hemoglobinuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho® SDF administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
Please see full Important Risk Information for more detailed risk information and Boxed Warning.
Please see WinRho SDF Prescribing Information for full prescribing details
Reference: 1. WinRho SDF Prescribing Information, December 2010