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Adverse events

• WinRho has a safety and tolerability profile established in clinical trials and more than 15 years of use

• In clinical trials, 7% of WinRho* infusions had at least one adverse reaction1

  1. – The most common adverse reactions were: headache (2%), chills (<2%) and fever (1%), which are expected adverse drug reactions following intravenous administration of human immune globulins1

* Studies performed using WinRho/WinRho SD

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).

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

• patients with known anaphylactic or severe hypersensitivity responses to human immune globulin products

• patients with autoimmune hemolytic anemia

• patients with pre-existing hemolysis or in patients at high risk for hemolysis

• patients who are IgA deficient with antibodies against IgA

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.

Use of Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. WinRho SDF does not contain sucrose. For patients at risk of renal dysfunction or failure, 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 Important Risk Information for more detailed risk information
Please see WinRho SDF Prescribing Information for full prescribing details

References: 1. WinRho SDF Prescribing Information, March 2010.