Important Safety Information

Privigen™ is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolemia, and in patients with selective IgA deficiency.

In patients at risk for developing renal failure, monitor renal function, including blood urea nitrogen and serum creatinine, and urine output.  Also monitor patients with risk factors for thrombotic events, including those with 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 has been reported to occur infrequently with Privigen™ and other IGIV treatments, especially with high doses and/or rapid infusion of IGIV.. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported; if transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.

Privigen™ is derived from human plasma. As with all plasma-derived products, 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™ in patients with PI were headache, pain, nausea, fatigue, and chills. The most common adverse reactions in subjects with chronic ITP were headache, pyrexia/hyperthermia, and anemia.