Patient selection
The risk of developing IVH and its complications may be reduced by careful patient selection1-3
Monitoring for signs and symptoms of IVH
• Closely monitor patients in a healthcare setting for at least 8 hours after administration
• Dipstick urinalysis 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, decreased urine output, sudden weight gain, fluid retention/edema and/or shortness of breath to their physician
• If signs and/or symptoms of IVH are present or suspected after WinRho administration, confirmatory post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
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
References: 1. WinRho SDF Prescribing Information, March 2010. 2. Data on file, Cangene Corporation. 3. Tarantino MD, Bussel JB, Cines, DB, et al. A closer look at intravascular hemolysis (IVH) following intravenous anti-D for immune thromobocytopenic purpura (ITP). Blood. 2007;109: 5527.