DIET & NUTRITION 
PATIENT EDUCATION 
OBESITY/WEIGHT MANAGEMENT 
EXERCISE/TRAINING 
LEGAL MATTERS 
GUIDELINES/RECOMMENDATIONS 📋 Regulatory Action / Label Change
The FDA approved cefepime-zidebactam (Zaynich) for complicated UTI and pyelonephritis caused by susceptible gram-negative organisms, including several drug-resistant species. Approval follows phase 3 data showing higher rates of symptom and microbiologic resolution compared with meropenem.
Professional Impact
- New antibiotic option covers Enterobacter, E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa for complicated UTI/pyelonephritis.
- Phase 3 trial showed 89.0% composite resolution vs. 68.4% for meropenem (95% CI, 12.3–29.5), though standalone clinical cure rates were nearly identical (97.5% vs. 97.8%).
- Treatment-emergent adverse events occurred more often with cefepime-zidebactam (31.8%) than meropenem (28.2%).
- Adds another option for multidrug-resistant gram-negative infections amid a tightening resistance landscape.
Action Items
- Review local antibiogram data for relevance to prescribing decisions.
- Evaluate formulary and stewardship criteria before first use.
- Monitor adverse event patterns given the modestly higher rate observed.
- Document susceptibility testing prior to use in resistant infections.
