Important Safety Information
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of human immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
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, who have had hypersensitivity reactions; such patients are at greater risk of developing severe hypersensitivity and anaphylactic reactions.
In patients at risk of developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine; discontinue if renal function deteriorates. Ensure that patients with preexisting renal insufficiency are not volume-depleted.
Thrombosis can occur with Privigen, as can hyperproteinemia, increased serum viscosity, or hyponatremia. Infrequently, aseptic meningitis syndrome (AMS) may occur—more frequently with high doses (2 g/kg) and/or rapid infusion.
Hemolysis, either intravascular or due to enhanced red blood cell sequestration, can develop subsequent to treatment. Risk factors include non-O blood group, underlying inflammation, and high doses. Closely monitor patients for hemolysis, especially those with preexisting anemia and/or cardiovascular or pulmonary compromise.
Consider the 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 and its variant (vCJD), cannot be completely eliminated.
In clinical studies of patients being treated with Privigen for PI, the most common adverse reactions, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature.
In clinical studies of patients being treated with Privigen for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. A serious adverse reaction was aseptic meningitis syndrome (AMS).
Treatment with Privigen might interfere with a patient’s response to live virus vaccines and could lead to misinterpretation of serologic testing. Use in pregnant women only if clearly needed. In patients over 65, do not exceed recommended dose and infuse at the minimum rate practicable.
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as replacement therapy for patients with primary immunodeficiency (PI), including but not limited to the humoral immune defect in 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).
Please see full prescribing information for Privigen.
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.