Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as
replacement therapy for patients with primary immunodeficiency (PI) associated with
defects in humoral immunity, including but not limited to common variable
immunodeficiency (CVID), X-linked agammaglobulinemia, congenital
agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined
immunodeficiencies. Privigen is also indicated to raise platelet counts in patients with
chronic immune thrombocytopenic purpura (ITP).
WARNING: Use of Immune Globulin Intravenous (IVIg) products, particularly
those containing sucrose, have been associated with renal dysfunction, acute renal
failure, osmotic nephropathy, and death. Privigen does not contain sucrose.
Administer Privigen at minimum rate practicable in patients at risk of renal
dysfunction or acute renal failure. At-risk patients include those with preexisting
renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia;
over 65 years of age; or receiving known nephrotoxic drugs. See full prescribing
information for complete boxed warning.
Privigen is contraindicated in patients with history of anaphylactic or severe systemic
reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient
patients with antibodies to IgA and history of hypersensitivity.
Monitor patient vital signs throughout infusion of Privigen. In cases of severe
hypersensitivity or anaphylactic reactions, discontinue administration and institute
appropriate medical treatment. In patients at risk for developing renal failure, monitor
urine output and renal function, including blood urea nitrogen and serum creatinine.
Thrombotic events have occurred in patients with risk factors; consider baseline
assessment of blood viscosity for those at risk of hyperviscosity.
Patients could experience increased serum viscosity, hyperproteinemia or hyponatremia;
infrequently, aseptic meningitis syndrome (AMS) may occur (most often with high doses
and/or rapid IVIg infusion).
Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can
develop subsequent to treatment with Privigen. Closely monitor patients for hemolysis
and hemolytic anemia. Risk factors for hemolysis include non-O blood group,
underlying inflammation, and high doses. Carefully consider relative risks and benefits
before prescribing high-dose regimen for chronic ITP in patients at increased risk of
thrombosis, hemolysis, acute kidney injury or volume overload.
Monitor patients for pulmonary adverse reactions and signs of transfusion-related acute
lung injury (TRALI).
Privigen is derived from human plasma. The risk of transmission of infectious agents,
including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be
In clinical studies of patients being treated with Privigen for PI, the most serious adverse
reaction was hypersensitivity (one subject). Adverse reactions observed in >5% of
subjects with PI were headache, pain, nausea, fatigue, chills, vomiting, joint
swelling/effusion, pyrexia, and urticaria.
In clinical studies of patients being treated with Privigen for chronic ITP, the most
serious adverse reactions were AMS (one subject) and hemolysis (eight subjects).
Adverse reactions seen in >5% of subjects with chronic ITP were headache,
pyrexia/hyperthermia, positive DAT, anemia, vomiting, nausea, increases in conjugated
and unconjugated bilirubin , hyperbilirubinemia, and increased blood lactate
Treatment with Privigen might interfere with a patient's response to live virus vaccines
and could lead to misinterpretation of serologic testing.
For more information about Privigen, please see full prescribing information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.