Safety and tolerability of a new intravenous immunoglobulin 10% in patients with primary immunodeficiency.

AIMS: Kedrion IVIg 10% (KIg10; QIVIGY) is a new, ready-to-use, 10% liquid IVIg (100 mg/mL) approved for adults with primary immunodeficiency (PI). This report presents safety and tolerability data from a phase III study. METHODS: This was an open-label, prospective, single-arm, historically controlled, multicenter study in adults with confirmed PI receiving commercially available IVIg products. Participants received KIg10 200-800 mg/kg once every 21 or 28 days for 17 and 13 infusions, respectively. RESULTS: Forty-seven participants received KIg10 every 21 days (n = 8) or every 28 days (n = 39). Overall, 97.9% (n = 46) of participants had treatment-emergent adverse events (TEAEs) and 46.8% (n = 22) experienced drug-related TEAEs; most were mild or moderate. Across 80 infusions, 122 infusional AEs occurred in 30 participants (63.8%); infusional AEs decreased with later versus initial infusions. No life-threatening TEAEs, deaths, serious or severe drug-related TEAEs, thrombotic events, or occurrences of aseptic meningitis, transfusion-related acute lung injury, acute renal failure, or neutropenia were observed. A drug-related hypersensitivity event (skin reaction) occurred in 1 participant. Forty-four (93.6%) participants reached the maximum dose rate (8 mg/kg/min). CONCLUSION: KIg10 was well tolerated in adults with PI, supporting its use as a replacement therapy option in this population.