Cefepime/Enmetazobactam (Exblifep)
4th Generation Cephalosporin | Antibiotic
Mechanism of Action
Exblifep, a combination of cefepime and enmetazobactam, acts by inhibiting bacterial cell wall synthesis. Cefepime, a fourth-generation cephalosporin, binds to and inhibits penicillin-binding proteins, which are crucial for cell wall synthesis in bacteria. Enmetazobactam enhances the activity of cefepime by inhibiting beta-lactamases, enzymes that many resistant bacteria produce to deactivate cephalosporins.
Indications
Exblifep is indicated for the treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by specific susceptible microorganisms like Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex. It is particularly effective against infections caused by bacteria producing extended-spectrum beta-lactamases (ESBLs).
Contraindications
Exblifep should not be used in patients who are hypersensitive to cefepime, other cephalosporins, or any other component of the formulation. It is also contraindicated in patients with severe hypersensitivity to other beta-lactam antibiotics.
Drug Interactions
Exblifep may decrease the effectiveness of live bacterial vaccines such as typhoid vaccine. It is recommended to avoid using live vaccines during treatment with Exblifep. Additionally, it should be used cautiously with drugs known to lower the seizure threshold or those that can affect renal function, as both cefepime and enmetazobactam are primarily eliminated by the kidneys.
Adverse Effects
Common adverse effects include increased liver enzymes, headache, and phlebitis at the infusion site. Serious adverse effects may include hypersensitivity reactions, potential neurotoxicity (especially in patients with renal impairment), and Clostridioides difficile-associated diarrhea. Monitoring for signs of anaphylaxis and adjusting the dose in renal impairment are recommended to mitigate these risks.
Additional Considerations
- Dosage Adjustments: Dosage adjustments are necessary for patients with renal impairment to prevent accumulation and potential toxicity. The standard dosage is 2.5 grams every 8 hours, adjusted based on the estimated glomerular filtration rate (eGFR).
- Administration: Exblifep is administered via intravenous infusion over approximately 2 hours, typically every 8 hours for 7 to 14 days, depending on the severity of the infection and patient response.
- Monitoring: Regular monitoring of renal function, liver enzymes, and complete blood counts is advised during treatment. Additionally, monitoring for signs of neurological changes indicative of potential neurotoxicity is crucial, especially in patients with compromised renal function or those receiving higher doses.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf —
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