Human Immunoglobulin G

1 INDICATIONS AND USAGE QIVIGY (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 )

6 ADVERSE REACTIONS The most common adverse reactions observed in ≥ 5% of patients were headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described in this section reflects exposure to QIVIGY in one clinical study.

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.

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin products, including QIVIGY. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors [see Warnings and Precautions (5.2) ] . 5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS QIVIGY 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) ] .