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For the treatment of ITP, administer WinRho SDF by the intravenous (IV) route into a suitable vein over a 3- to 5-minute period. Be sure to administer WinRho SDF separately from other drugs.
If dilution of WinRho SDF is preferred prior to IV administration, use normal saline as diluent. Do not use dextrose (5%) in water (D5W). No other diluents have been tested.
All patients should be monitored to determine clinical response by assessing platelet counts, RBCs, Hgb, and reticulocyte levels.
Conversion of IU to mcg is: 5 IU = 1 mcg.
If Hgb <8g/dL, alternative treatments should be used.

Initial Dosing is based on patient weight and can be calculated in either IU (International Units) or mcg (micrograms), as shown in the example below.

250 IU/kg = 50 mcg/kg*†
Weight Total Dose
kg IU mcg
10 2500 500
250 IU/kg = 50 mcg/kg
*May be administered as 2 divided doses given on separate days, if desired.
For patients with Hgb between 8 and 10 g/dL, a reduced dose of 125 to 200 IU/kg (25–40 mcg/kg) is recommended.

Short Infusion Times

  • 3 to 5 minutes with WinRho SDF
  • You may prefer to administer the dose over longer periods of time, such as 30 minutes.
  • Monitor WinRho SDF patients for at least 8 hours postinfusion for signs and symptoms of intravascular hemolysis (IVH)
  • During this time, patients are free to move about in the healthcare setting

Subsequent dosing will also vary based upon a patient's weight. Below is an example of dosing when that weight is 10kg.

  For patients with Hgb >10 g/dL (250 to 300 IU/kg or 50 to 60 mcg/kg) For patients with Hgb between 8 and 10 g/dL (125 to 200 IU/kg or 25 to 40 mcg/kg)
Weight Total Dose Reduced Dose
kg IU mcg IU mcg
10 2500-3500 500-600 1250-2000 250-400
250 IU/kg = 50 mcg/kg

Please scroll down to view complete Important Safety Information including BOX WARNING.

Important Safety Information


Intravascular hemolysis leading to death has been reported in patients treated for 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 to monitor for hematuria and hemoglobinuria at baseline and 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 hematuria. Absence of these signs and/or symptoms of IVH within eight hours does 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).


WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use 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 thrombocytopenia (ITP)
  • Adults with chronic ITP
  • Children and adults with ITP secondary to HIV infection

The safety and efficacy of WinRho® SDF 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.

Important Safety Information

For use in the treatment of ITP, do not use WinRho SDF in:

  • Patients who have had known anaphylactic or severe systemic reaction to the administration of human immune globulin products
  • IgA deficient patients with antibodies to IgA and a history of hypersensitivity
  • Patients with autoimmune hemolytic anemia, with pre-existing hemolysis or at high risk for hemolysis

The liquid formulation of WinRho® SDF contains maltose. Maltose in IGIV products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving WinRho® SDF Liquid.

WinRho® SDF is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The safety and efficacy of WinRho® SDF 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.

Acute renal dysfunction/failure, osmotic nephropathy, and death may occur upon use of Immune Globulin Intravenous (IGIV) products, including WinRho® SDF. Ensure that patients are not volume depleted before administering WinRho® SDF. For patients at risk of renal dysfunction or failure, including those with any degree of pre‑existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs, administer WinRho® SDF at the minimum infusion rate practicable.

In Rho(D)-positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably decreased hemoglobin, can be expected. In most cases, the red blood cell destruction is believed to occur in the spleen.

Thrombotic events may occur following treatment with WinRho® SDF and other IGIV products.

Noncardiogenic pulmonary edema [Transfusion-related Acute Lung Injury (TRALI)] may occur in patients following IGIV treatment.

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 Prescribing Information for complete prescribing details.