What is it prescribed for?
EXBLIFEP, Approved on February 22, 2024, is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
What is the name of the drug and what does it do?
Exblifep (pronounced ex-BLI-fep), (generic name: cefepime and enmetazobactam), is a combination medication indicated for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by specific susceptible microorganisms.
How does it work?
Exblifep is composed of cefepime, a cephalosporin antibiotic, and enmetazobactam, a beta-lactamase inhibitor. Cefepime works by disrupting the synthesis of the bacterial cell wall, which is essential for bacterial growth and survival. Enmetazobactam protects cefepime from being broken down by beta-lactamase enzymes produced by some bacteria, thereby enhancing the antibiotic’s effectiveness.
What did the research discover?
Clinical trials demonstrated that Exblifep is effective in treating cUTI. In a phase 3 comparator-controlled trial, Exblifep showed a higher composite response rate (79.1%) compared to piperacillin/tazobactam (58.9%) at the test of cure visit. This indicates that Exblifep was more effective in achieving clinical cure and microbiological response in patients with cUTI, including those with pyelonephritis.
What are some of the side effects?
Common side effects of Exblifep include:
- Increased transaminases
- Increased bilirubin
- Headache
- Phlebitis/infusion site reactions
- Diarrhea
- Anemia
- Hypersensitivity
- Vomiting
- Nausea
What are the dosage recommendations and how is it prescribed?
The recommended dosage of Exblifep for adults with normal renal function (eGFR 60-129 mL/min) is 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam) administered every 8 hours by intravenous infusion over 2 hours for 7 to 14 days. Dosage adjustments are required for patients with renal impairment and those with eGFR greater than or equal to 130 mL/min.
Source:
Allecra Therapeutics SAS. Exblifep (cefepime and enmetazobactam) for injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf
