Monitoring Patients During IVIg Infusion
The patient's vital signs should be observed and monitored carefully throughout
the infusion. If side effects occur, the infusion should be slowed or stopped until
the symptoms subside. The infusion may then be resumed at a lower rate that is comfortable
for the patient.
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may
be associated with the administration of Immune Globulin Intravenous (Human) (IVIg)
products in predisposed patients. Administer IVIg products at the minimum infusion
rate possible. Renal dysfunction and acute renal failure occur more commonly in
patients receiving IVIg products containing sucrose. Privigen does not contain sucrose.
See full Prescribing Information for complete Boxed Warning.
Summary of Warnings and Precautions
- Immunoglobulin A (IgA)-deficient patients with antibodies to IgA are at greater
risk of developing severe hypersensitivity and anaphylactic reactions
- Monitor renal function, including blood urea nitrogen and serum creatinine, and
urine output in patients at risk of developing acute renal failure
- Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients
receiving IVIg therapy
- Thrombotic events may occur. Monitor patients with known risk factors for thrombotic
events; consider baseline assessment of blood viscosity for those at risk for hyperviscosity
- Aseptic meningitis syndrome may occur, especially with high doses or rapid infusion
- Hemolysis can develop subsequent to Privigen treatments due to enhanced red blood
cell sequestration. Monitor patients for hemolysis and hemolytic anemia
- Monitor patients for pulmonary adverse reactions (transfusion-related acute lung
injury [TRALI])
- Avoid use of the high-dose regimen (for chronic immune thrombocytopenic purpura
[ITP]) in patients with expanded fluid volume or where fluid volume is of concern
- Privigen is made from human plasma and may contain infectious agents, eg, viruses
and, theoretically, the Creutzfeldt-Jakob disease agent
- Passive transfer of antibodies may confound serologic testing
Please see the Important Safety Information and
full Prescribing Information.
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Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen® is indicated for the treatment of 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 rapidly raise platelet counts to prevent bleeding in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Thrombotic events have been reported with Privigen and other IVIg treatments. Monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Aseptic meningitis syndrome (AMS) may occur infrequently with Privigen and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. There have been reports of noncardiogenic pulmonary edema in patients administered IVIg. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.
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, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/hyperthermia, fatigue, and chills. Anemia was an additional common adverse reaction in patients being treated with Privigen for chronic ITP. The most serious adverse reactions in chronic ITP patients were aseptic meningitis syndrome in one subject and hemolysis in eight subjects.
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.