Immune Globulin Intravenous (Rho-D) [Human]
- 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 (ARDS)
- Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- 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, 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).
Updated January 2018