BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

Immune Globulin Intravenous (Rho-D) [Human]

Intravascular Hemolysis

  • 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).

Package Inserts

RHo (d) Immune Globulin - WINRHO

Human RHo (d) Immune Globulin - RHOPHYLAC

Updated January 2018