WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)] is a purified human immunoglobulin used to treat immune thrombocytopenic purpura (ITP)
WinRho has a safety and tolerability profile established in clinical trials and more than 15 years of use1,2
WinRho SDF Liquid is Bioequivalent to WinRho SDF Lyophilized1
In two comparative pharmacokinetic studies (n=101), the formulations were bioequivalent following IV administration based on the area under the curve to 84 days and had comparable pharmacokinetics following IM administration. Both formulations also had similar elimination half-lives. 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 for immune thrombocytopenic purpura (ITP) with WinRho SDF.
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. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration 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 hematuria. 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 administration post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH and plasma bilirubin (direct and indirect).
General adverse reactions associated with the use of WinRho SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events (≤ 2% of infusions) were headache, chills, and fever.
Please see full Important Risk Information for more detailed risk information
Please see WinRho SDF Prescribing Information for full prescribing details