For US Healthcare Professionals
For US HCPs
Prescribing Information
IMAAVY® (nipocalimab-aahu)
Patient Enrollment Form
MOA
IgG Reduction
Immunoselectivity

IMAAVY is designed to address a key underlying mechanism of RBC destruction in wAIHA1-4

By blocking FcRn, IMAAVY may reduce circulating IgG, including pathogenic IgG autoantibodies, which lead to the immune-mediated destruction of red blood cells (RBCs)1,2,5
IMAAVY mechanism of action diagram
IMAAVY mechanism of action diagram

Based on in vivo and/or in vitro studies.1 The clinical significance of these characteristics is not fully known.

FcRn=neonatal fragment crystallizable receptor; IgG=immunoglobulin G; RBC=red blood cell; wAIHA=warm autoimmune hemolytic anemia.

IMAAVY reduces circulating IgG, including
pathogenic IgG autoantibodies1

The median reduction in total IgG at Week 1 was ~70%1
Reductions in total IgG were observed with IMAAVY at Week 1 and through Week 241
Decreases in pathogenic anti-RBC autoantibodies were observed at Week 1 and through Week 241

Based on in vivo studies.1 The clinical significance of these characteristics is not fully known.

IgG=immunoglobulin G; RBC=red blood cell.

IMAAVY is designed to target and reduce pathogenic IgG autoantibodies while preserving B-cell function1-3

IMAAVY is immunoselective, designed to reduce only IgG, including pathogenic IgG, while preserving key humoral and cellular immune function1,2,4
Immune system impact5,6
IMAAVY immunoselectivity diagram
IMAAVY immunoselectivity diagram

Based on in vivo and/or in vitro studies. The clinical significance of these characteristics is not fully known.3

IgA=immunoglobulin A; IgD=immunoglobulin D; IgE=immunoglobulin E; IgG=immunoglobulin G; IgM=immunoglobulin M.

IMAAVY is designed to address a key underlying mechanism of RBC destruction in wAIHA1-4

By blocking FcRn, IMAAVY may reduce circulating IgG, including pathogenic IgG autoantibodies, which lead to the immune-mediated destruction of red blood cells (RBCs)1,2,5
IMAAVY mechanism of action diagram
IMAAVY mechanism of action diagram

Based on in vivo and/or in vitro studies.1 The clinical significance of these characteristics is not fully known.

FcRn=neonatal fragment crystallizable receptor; IgG=immunoglobulin G; RBC=red blood cell; wAIHA=warm autoimmune hemolytic anemia.

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Once you’ve made the decision to prescribe IMAAVY

Sign your patients up for support to help begin their IMAAVY journey

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References: 1. Seth NP, Xu R, DuPrie M, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):1–22. doi:10.1080/19420862.2025.2461191 2. Fattizzo B, Murakhovskaya I, Ueda Y, et al. Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized double-blind ENERGY study. Presented at: European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden. Abstract S300. 3. Fattizzo B, Ling LE, Barcellini W. Targeting the neonatal Fc receptor (FcRn) in hematologic conditions with a focus on warm autoimmune hemolytic anemia. Blood Rev. 2025;74:101328. doi:10.1016/j.blre.2025.101328 4. Fattizzo B, Murakhovskaya I, Ueda Y, et al. Pharmacodynamic effect of nipocalimab in warm autoimmune hemolytic anemia (WAIHA) and correlation with clinical improvement. Poster presented at: European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden. Poster PF1297. 5. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 6. Ling LE, Hillson JL, Tiessen RG, et al. M281, an anti-FcRn antibody: pharmacodynamics, pharmacokinetics, and safety across the full range of IgG reduction in a first-in-human study. Clin Pharmacol Ther. 2019;105(4):1031-1039. doi:10.1002/cpt.1276