Intravascular haemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho® SDF.
IVH can lead to clinically compromising anaemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
Serious complications including severe anaemia, 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 health care 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 discoloured urine or haematuria.
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 haemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
Rho(D) Immune Globulin Intravenous (Human) (Rho(D) IGIV) - WinRho® SDF - is available as a sterile, lyophilized or liquid gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen (D antigen).
WinRho® SDF is prepared from human plasma by an anion-exchange column chromatography method.
The manufacturing process includes a solvent detergent treatment step (using tri-n-butyl phosphate and Triton® X-100) that is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV.
WinRho® SDF is filtered using a Planova™ 20N virus filter which has been validated to be effective in the removal of some non-lipid enveloped viruses.
These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively.
The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard. A 1,500 Unit (International Unit [IU])* (300 microgram).
