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These highlights do not include all the information needed to use BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV™ (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) 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 BKEMV 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 labelWhy this: Advisory · dailymed-prescription
BKEMV is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. BKEMV is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). BKEMV is indicated for treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.
- generic_name
- eculizumab-aeeb
- product_names
- eculizumab-aeeb
- ndc
- 55513-180, 55513-180-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en