Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

Dosing / Administration

The entire dose of WinRho SDF may be injected into a suitable vein over three to five minutes. WinRho SDF should be administered separately from other drugs.

Dosage administration

Safety and efficacy of WinRho SDF in the treatment of ITP at doses exceeding 300 IU/kg (60 µg/kg) has not been established.

• WinRho SDF is available in convenient dosing sizes to meet the needs of your ITP patients: 1,500 IU (300 µg), 2,500 IU (500 µg), 5,000 IU (1,000 µg), and 15,000 IU (3,000 µg) vials

  1. – The conversion of micrograms to Units [IU] is: 1 microgram = 5 Units

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.

important risk information

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).

Please see full Important Risk Information for more detailed risk information
Please see WinRho SDF Prescribing Information for full prescribing details

Reference 1. WinRho SDF Prescribing Information, March 2010.