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Careful patient selection may reduce risk

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Safety and tolerability

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%)1

Labeling revision

Labeling was revised to give health care professionals a clear understanding of potential medical complications associated with WinRho.

  1. – Based upon voluntary spontaneous reports received by Cangene's pharmacovigilance, there has been no increase in IVH or its complications2

  2. – The label change comes as a result of signal detection analysis of the WinRho post-marketing data that found some of the reports of IVH or its complications were associated with fatal outcomes.

Estimated reporting rate of hemoglobinemia and/or hemoglobinuria following administration of anti-D for immune thrombocytopenic purpura (ITP)3

• The calculated reporting rate should not be interpreted as an incidence rate due to important limitations for both the numerator and denominator, including underreporting and under- or overestimation of units of anti-D IGIV distributed

Safety tolerability

Disseminated intravascular coagulation (DIC), a rare serious complication of IVH, has been reported4

* Clinical trials of subjects (n=161) with childhood ITP, adults and children with chronic ITP, and adults with ITP secondary to HIV treated with 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).

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

References. 1. WinRho SDF prescribing information, March 2010. 2. Data on file, Cangene Corporation. 3. Gaines AR. Acute onset hemoglobinemia and/or hemoglobinuria and sequelae following Rho(D) immune globulin intravenous administration in immune thrombocytopenic purpura patients. Blood.2000:95:2523-2529. 4. Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood. 2005;106:1532-1537.