Eculizumab-aeeb

(Bkemv®)

Bkemv®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 300 mg/30 mL [10 mg/mL])
Drug ClassComplement inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
  • Indicated for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Complement inhibitors (Eculizumab, Ravulizumab, Pegcetacoplan) significantly reduced Lactate Dehydrogenase (LDH) levels (-1462.0 U/L for ≤26 weeks and -1696.5 U/L for >26 weeks) and increased hemoglobin levels (1.4 g/dL and 1.9 g/dL) in patients with paroxysmal nocturnal hemoglobinuria (PNH), with at least 50% of patients avoiding transfusions.
  • Atypical Hemolytic Uremic Syndrome (aHUS): Eculizumab and Ravulizumab demonstrated comparable efficacy in the treatment of aHUS, with Ravulizumab being preferred due to its lower cost and less frequent dosing. In renal transplant patients, Eculizumab significantly reduced the risk of recurrence (odds ratio (OR) = 0.05), the need for dialysis (OR = 0.13), and rejection (OR = 0.09).
  • Pegcetacoplan effectively increased hemoglobin levels and reduced transfusion requirements in patients with PNH, with minimal adverse events reported.
  • In studies on paroxysmal nocturnal hemoglobinuria (PNH) with complement inhibitors, no deaths were reported, and few adverse events occurred in pegcetacoplan-treated patients. Serious adverse events were noted in 42% of patients in aHUS studies, with two cases of meningococcal infection reported in eculizumab-treated patients.
  • Eculizumab in renal transplant patients with aHUS showed improved renal outcomes, including reduced need for dialysis, without specific safety concerns mentioned.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Bkemv (eculizumab-aeeb) Prescribing Information.2024Amgen Inc., One Amgen Center Drive Thousand Oaks, CA

Systematic Reviews / Meta-Analyses