When to Use Blujepa (Gepotidacin) in Clinical Practice
Blujepa (gepotidacin) should be used in female adult and pediatric patients aged ≥12 years weighing ≥40 kg with uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus, or E. faecalis. 1
Approved Indications
Blujepa is FDA-approved specifically for uncomplicated urinary tract infections in a defined patient population. 1 The drug represents a novel bacterial type II topoisomerase inhibitor (BTI) antibacterial developed by GSK. 1
Patient Selection Criteria
- Age requirement: Patients must be ≥12 years old 1
- Weight requirement: Patients must weigh ≥40 kg 1
- Sex limitation: Currently approved only for female patients 1
- Infection type: Only for uncomplicated urinary tract infections 1
Microbiological Coverage
Blujepa should be used when uUTI is caused by susceptible isolates of the following organisms: 1
- Escherichia coli
- Klebsiella pneumoniae
- Citrobacter freundii complex
- Staphylococcus saprophyticus
- Enterococcus faecalis
Clinical Context for Use
Blujepa represents an important alternative in the era of increasing antimicrobial resistance, particularly as a non-fluoroquinolone option for uUTIs. 1 As a triazaacenaphthylene bacterial type II topoisomerase inhibitor, it offers a distinct mechanism of action from traditional antibiotics. 1
When NOT to Use Blujepa
- Do not use in male patients (not FDA-approved for this population) 1
- Do not use in patients <12 years old 1
- Do not use in patients weighing <40 kg 1
- Do not use for complicated UTIs (only approved for uncomplicated infections) 1
- Do not use for uncomplicated urogenital gonorrhea (despite being in development for this indication, it is not yet FDA-approved) 1
Important Caveats
Susceptibility testing should guide therapy when available, as gepotidacin's approval is limited to susceptible isolates. 1 The narrow FDA approval reflects the specific populations studied in clinical trials, and use outside these parameters lacks supporting efficacy and safety data.
This represents a first-in-class mechanism requiring careful attention to the approved indication, as off-label use in unapproved populations (males, younger children, complicated infections) has not been evaluated for safety or efficacy. 1