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(immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for treatment of adults with primary humoral immunodeficiency (PI). ( 1 )

is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. QIVIGY is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with history of anaphylactic or severe systemic reactions to human immune globulins. ( 4 ) IgA deficient patients with antibodies against IgA and a history of hypersensitivity. ( 4 )

Hypersensitivity Reactions: In case of a severe hypersensitivity reaction, discontinue QIVIGY infusion, and manage as appropriate. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. ( 5.1 ) Thrombotic events: Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. ( 5.2 ) Hyperproteinemia, hyperviscosity, hyponatremia, or pseudohyponatremia may occur in patients receiving IGIV therapy. ( 5.4 ) Renal Injury: Ensure patients are not volume depleted before administering QIVIGY. Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients receiving QIVIGY prior to initial infusion and at appropriate intervals thereafter. ( 5.3 ) Aseptic Meningitis Syndrome (AMS) may occur, more frequently in association with high doses of IGIV or rapid infusion. ( 5.5 ) Hemolysis: Risk factors include high doses and non-O blood group. Monitor patients for hemolysis and hemolytic anemia. ( 5.6 ) Transfusion-related acute lung injury (TRALI): Monitor patients for symptoms of TRALI and manage using oxygen therapy with adequate ventilatory support as appropriate. ( 5.7 ) Transmission of infectious agents: QIVIGY is made from human plasma and may carry a risk of transmitting infectious agents. ( 5.8 ) 5.1 Hypersensitivity Severe hypersensitivity reactions, including anaphylaxis, …

8.1 Pregnancy Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with QIVIGY. It is not known whether QIVIGY can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation. QIVIGY should be given to pregnant women only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 - 4% and 15 - 20%, respectively.