Bkemv (Eculizumab-Aeeb) for Myasthenia Gravis

Overview

Bkemv is approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis in adults who test positive for anti-acetylcholine receptor (AchR) antibodies. Bkemv is a biosimilar to Soliris (eculizumab), which means it is highly similar to the FDA-approved reference product with no clinically meaningful differences in terms of safety, purity, and potency. Bkemv is also known by its drug name, eculizumab-aeeb.

Bkemv is a complement inhibitor, which means it works by blocking part of the immune system called the complement system. In people with generalized myasthenia gravis, this helps prevent immune system attacks on the neuromuscular junction, improving muscle function and reducing symptoms like muscle weakness.

How do I take it?

Prescribing information states that Bkemv is given as an intravenous (IV) infusion. For adults with generalized myasthenia gravis, the recommended dosing schedule is once weekly for the first four weeks, followed by a higher dose in the fifth week, and then that same dose every two weeks thereafter. Infusions should be administered on schedule or within two days of the scheduled time. Bkemv should be taken exactly as prescribed by a healthcare provider.

Side effects

Common side effects of Bkemv include musculoskeletal pain (pain in the muscles, bones, or joints), which was the most frequently reported adverse reaction in people with generalized myasthenia gravis.

Rare but serious side effects may include life-threatening infections caused by Neisseria meningitidis (a type of bacteria that causes meningococcal infections), even in vaccinated individuals. Other risks include severe infusion-related reactions and increased risk of infections in people with other systemic illnesses. Because of these risks, a person must be vaccinated against meningococcal infection at least two weeks prior to starting Bkemv, unless starting the drug sooner is considered necessary. Bkemv is only available through a restricted program.

For more information about this treatment, visit:
Label: Bkemv — Eculizumab-Aeeb Injection, Solution, Concentrate — DailyMed