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. Patients with IgA deficiency and antibodies to IgA are at greater risk of severe hypersensitivity and anaphylactic reactions.
In patients at risk for 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 or otherwise predisposed are not volume-depleted and administer Privigen at the minimum rate of infusion practicable.
Thrombosis might occur with Privigen, even in the absence of known risk factors. Patients could also experience 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 and hemolytic anemia. 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, 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 headache, elevated body temperature, positive DAT, anemia, nausea, epistaxis, vomiting, increases in conjugated and unconjugated bilirubin, decreased hematocrit, and increased blood lactate dehydrogenase. 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 or in any patient at risk of developing renal insufficiency, do not exceed recommended dose and infuse Privigen at the minimum rate practicable.
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).
Please see full prescribing information for Privigen.
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