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Safety & Tolerability

In clinical trials, 7% of WinRho® SDF infusions had at least one adverse reaction:1

  • The most common adverse reactions were headache (2%), chills (<2%), and fever (1%) (n=848 infusions)
  • Patients should be instructed to immediately report symptoms of back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath to their doctor
  • 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

Disseminated intravascular coagulation (DIC), a rare serious complication of IVH, has been reported.2

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

Patient Selection Guidelines

Incidence of IVH among patients treated with WinRho SDF for ITP is rare.3,4 The risk of intravascular hemorrhage (IVH) and its complications may be reduced by careful patient selection.1,5,6

Patients considered for treatment with WinRho SDF should be:

  • Diagnosed with Primary ITP
  • <65 years of age
  • Rho(D) positive
  • Non-splenectomized

Patients considered for treatment with WinRho SDF should not suffer from comorbid conditions such as:

  • Underlying cardiorespiratory disease
  • Prothrombotic conditions
  • Renal insufficiency or renal failure

Recommended lab tests before initiating WinRho SDF therapy are:

  • Blood type and count
  • Negative Direct Antiglobulin test (DAT or Coombs’ test)
  • Hemoglobin level
  • Reticulocyte count
  • Dipstick urinalysis

Hemoglobin level should be >8 g/dL. A reduced dose of WinRho SDF is recommended for patients with hemoglobin levels between 8 and 10 g/dL. If hemoglobin level is <8 g/dL, alternative therapy should be used.

Patients considered at risk for developing IVH include those with:

  • Pre-existing hemolytic conditions
  • Autoimmune hemolytic anemia (Evan’s Syndrome)
  • Systemic lupus erythematosus (SLE)
  • Antiphospholipid antibody syndrome
  • ITP secondary to other conditions that include:
  • Leukemia or lymphoma
  • Active infections (other than HIV) including hepatitis C

WinRho SDF should be prescribed with extreme caution or alternative therapies considered in patients of advanced age (65 and over) with comorbid conditions.

*This list of criteria is for guidance only and does not replace a complete physician’s assessment.

Monitoring for signs and symptoms of IVH when treating ITP patients with WinRho SDF is required

  • Patients should be closely monitored in a healthcare setting for at least 8 hours after administration
  • Dipstick urinalysis should be taken at baseline, 2 hours, 4 hours, and 8 hours after administration
  • Patients should be instructed to immediately report symptoms of back pain, shaking, fever, discolored urine, decrease urine output, sudden weight gain, fluid retention/edema, and shortness of breath to their physician
  • If signs and/or symptoms of IVH are present or suspected after administration of WinRho SDF, confirmatory post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, lactate dehydrogenase, and plasma bilirubin (direct and indirect)

Important Safety Information

WARNING: INTRAVASCULAR HEMOLYSIS (IVH)

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).

INDICATION

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.