Wockhardt：Zaynich ™ (Zidebactam and Cefepime)was approved
FDA Approves Zaynich for the Treatment of Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis, Caused by Specific Susceptible Microorganisms in Adult Patients
Dosage Form: Lyophilized powder for injection: 3 g (cefepime and zidebactam) as a sterile powder in a single-dose vial for reconstitution. Each vial contains cefepime 2 g and zidebactam 1 g.
Recommended Dosage
For adult patients with estimated glomerular filtration rate (eGFR) ≥60 mL/min, the recommended dosage is 3 g (cefepime 2 g and zidebactam 1 g) administered intravenously over 1 hour every 8 hours for 7 to 10 days.
Dosage Adjustment for Renal Impairment
For adult patients with renal impairment and eGFR <60 mL/min, dosage adjustment is recommended. Each intravenous dose should be administered over 1 hour.
Indication
Zaynich™ (zidebactam and cefepime) is a combination drug consisting of cefepime (a cephalosporin antibacterial) and zidebactam (a β-lactamase inhibitor). It is indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by specific susceptible microorganisms in adult patients.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Mechanism of Action
Zaynich™ (zidebactam and cefepime) is a combination drug consisting of cefepime (a cephalosporin antibacterial) and zidebactam (a β-lactamase inhibitor and non-β-lactam antibacterial). Cefepime primarily targets penicillin-binding protein 3 (PBP3) in Gram-negative bacterial pathogens, while zidebactam selectively inhibits penicillin-binding protein 2 (PBP2). Cefepime and zidebactam act synergistically by binding to multiple PBPs to kill bacteria. This synergy occurs even in the presence of β-lactamases, including metallo-β-lactamases (MBLs) which are not inhibited by zidebactam, as well as other non-enzymatic cefepime resistance mechanisms such as enhanced efflux and downregulation of outer membrane porin channels. This may be due to cefepime binding to its PBP targets more rapidly than it is hydrolyzed by β-lactamases. Zidebactam, as a non-β-lactam antibiotic, is not readily degraded by β-lactamases. Zidebactam demonstrates in vitro activity against certain Enterobacteriaceae and Pseudomonas aeruginosa isolates. The zidebactam component of ZAYNICH is active in vitro against Ambler class A (SHV, TEM, CTX-M, and KPC) and class C (CMY) β-lactamases.
ZAYNICH demonstrates in vitro activity against Enterobacteriaceae isolates genetically confirmed to contain Ambler class A (e.g., KPCs), class B (e.g., NDM, VIM, and IMP), class C (e.g., CMY), and class D β-lactamases (e.g., OXA-48-like). In P. aeruginosa, ZAYNICH demonstrates in vitro activity against isolates with elevated AmpC expression as well as isolates genetically confirmed to contain MBLs, OXAs, VEB, GES, KPC, and isolates with oprD downregulation, enhanced efflux, or PBP mutations.
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