A Drug Monograph: Cefepime-Enmetazobactam

Abstract

Cefepime-enmetazobactam is a novel antibacterial agent that combines cefepime, a fourth-generation cephalosporin, with enmetazobactam, a broad-spectrum β-lactamase inhibitor. This combination was developed to enhance efficacy against Gram-negative bacteria producing extended-spectrum β-lactamases (ESBLs). While cefepime exhibits strong gram-positive and gram-negative activity, its susceptibility to β-lactamase-producing pathogens is limited. Enmetazobactam significantly enhances cefepime's activity by inhibiting Ambler class A β-lactamases and certain class C β-lactamases. Clinical studies have demonstrated the effectiveness of cefepime-enmetazobactam in treating severe infections, including complicated urinary tract infections and intra-abdominal infections. According to FDA and EMA guidelines, this combination is considered a potential alternative for infections caused by carbapenem-resistant Enterobacterales. Additionally, it has demonstrated a superior efficacy profile compared to traditional β-lactam/β-lactamase inhibitor combinations. Cefepime-enmetazobactam is being evaluated as an alternative to carbapenems, offering a valuable option in the global fight against antibiotic resistance. This review discusses the pharmacodynamic and pharmacokinetic properties, clinical efficacy, resistance mechanisms, and current clinical trial data of cefepime-enmetazobactam in detail.

Keywords

• Cefepime-enmetazobactam
• β-lactamase inhibitor
• antibiotic resistance
• extended-spectrum β-lactamases
• complicated urinary tract infections

Bir İlaç Monografı: Sefepim-Enmetazobaktam

Abstract

Sefepim-enmetazobaktam, dördüncü nesil sefalosporin olan sefepim ile geniş spektrumlu bir β-laktamaz inhibitörü olan enmetazobaktam kombinasyonundan oluşan yeni bir antibakteriyel ajandır. Bu kombinasyon, özellikle genişletilmiş spektrumlu β-laktamaz (ESBL) üreten gram-negatif bakterilere karşı etkinliği artırmak amacıyla geliştirilmiştir. Sefepim, güçlü gram-pozitif ve gram-negatif aktivite gösteren bir sefalosporin olmasına rağmen, β-laktamaz üreten patojenlere karşı duyarlılığı sınırlıdır. Enmetazobaktam ise Ambler sınıf A β-laktamazları ve bazı sınıf C β-laktamazlarını inhibe ederek sefepimin etkinliğini önemli ölçüde artırmaktadır. Klinik çalışmalarda, sefepim-enmetazobaktamın özellikle komplike idrar yolu enfeksiyonları ve karın içi enfeksiyonlar dahil olmak üzere çeşitli ciddi enfeksiyonlarda etkinliği gösterilmiştir. FDA ve EMA tarafından belirlenen kriterlere göre, bu kombinasyonun karbapenem direncine sahip Enterobacterales suşları üzerinde etkili olabileceği belirtilmektedir. Ayrıca, geleneksel β-laktam/β-laktamaz inhibitör kombinasyonlarına kıyasla daha güçlü bir etkinlik profiline sahip olduğu gösterilmiştir. Sefepim-enmetazobaktam, karbapenemlere alternatif bir seçenek olarak değerlendirilmekte olup, antibiyotik direncinin küresel düzeyde yönetilmesine katkı sağlayabilecek önemli bir ajan olarak öne çıkmaktadır. Bu derlemede, sefepim-enmetazobaktamın farmakodinamik ve farmakokinetik özellikleri, klinik etkinliği, direnç mekanizmaları ve mevcut klinik çalışma verileri detaylı olarak ele alınacaktır.

Keywords

• β-laktamaz inhibitörü
• Sefepim-enmetazobaktam
• antibiyotik direnci
• genişletilmiş spektrumlu β-laktamaz
• komplike idrar yolu enfeksiyonları

Ethical Statement

Etik kurul iznine gerek duyulmamıştır.

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