These highlights do not include all the information needed to use EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI® (eculizumab-aagh) injection, for intravenous useInitial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of EPYSQLI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to SOLIRIS (eculizumab).

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These highlights do not include all the information needed to use EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI® (eculizumab-aagh) injection, for intravenous useInitial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of EPYSQLI has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to SOLIRIS (eculizumab).

Medication label

Why this: Advisory · dailymed-prescription

EPYSQLI is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. EPYSQLI is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). EPYSQLI is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. EPYSQLI is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

generic_name: eculizumab-aagh
product_names: Eculizumab-aagh
ndc: 51759-208, 51759-208-13
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en