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U.S. Department of Health and Human Services

Safety

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Privigen Immune Globulin Intravenous (Human) 10% Liquid

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics and Research (CBER) – June 2012

 

Summary View

 

WARNINGS AND PRECAUTIONS

Hemolysis
  • Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of Privigen.
  • The following risk factors may be associated with the development of hemolysis: high doses (e.g., ≥2 g/kg), given either as a single administration or divided over several days, and non-O blood group.11 Other individual patient factors, such as an underlying inflammatory state (as may be reflected by, for example, elevated C-reactive protein or erythrocyte sedimentation rate), have been hypothesized to increase the risk of hemolysis following administration of IGIV,12 but their role is uncertain. Hemolysis has been reported following administration of IGIV for a variety of indications, including ITP and PI.9
  • Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors noted above. Consider appropriate laboratory testing in higher risk patients, including measurement of hemoglobin or hematocrit prior to infusion and within approximately 36 to 96 hours post infusion.