When to Use Blujepa (Gepotidacin) in Patients with Renal or Hepatic Impairment
Avoid Blujepa (gepotidacin) in patients with severe renal impairment (eGFR <30 mL/min) or severe hepatic impairment (Child-Pugh Class C) due to increased drug exposure and risk of QTc prolongation. 1
Contraindications Based on Organ Function
Severe Renal Impairment (eGFR <30 mL/min)
- Do not use gepotidacin in patients with eGFR <30 mL/min, including those receiving dialysis 1
- The mechanism involves increased gepotidacin plasma concentrations (Cmax), which elevates the risk of dose-dependent QTc interval prolongation 1
- If gepotidacin cannot be avoided in these patients, obtain baseline ECG, monitor and correct serum electrolyte abnormalities, and collect ECGs during treatment as clinically indicated 1
Severe Hepatic Impairment (Child-Pugh Class C)
- Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) 1
- Similar to severe renal impairment, this restriction is based on increased drug exposure and QTc prolongation risk 1
- If administration cannot be avoided, implement the same monitoring strategy: baseline ECG, electrolyte correction, and serial ECG monitoring during treatment 1
Mild to Moderate Renal or Hepatic Impairment
Practical Approach
- The FDA label does not specify dose adjustments or contraindications for mild to moderate renal or hepatic impairment 1
- Patients with mild to moderate impairment who meet other eligibility criteria (female, ≥12 years old, ≥40 kg body weight, uncomplicated UTI with susceptible organisms) may receive standard dosing: 1,500 mg (two 750 mg tablets) orally twice daily for 5 days 1
- Administer after meals to reduce gastrointestinal intolerance 1
Additional Monitoring Considerations
QTc Prolongation Risk Factors
- Beyond renal and hepatic impairment, avoid gepotidacin in patients with: 1
- History of QTc interval prolongation
- Pre-existing cardiac disease (arrhythmias, heart failure, structural heart disease)
- Concomitant use of antiarrhythmic agents or other QTc-prolonging medications
- Concomitant use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole) which increase gepotidacin exposure 1
Acetylcholinesterase Inhibition
- Monitor patients with conditions that may be exacerbated by acetylcholinesterase inhibition (myasthenia gravis, Parkinson's disease) 1
- Watch for adverse reactions including dysarthria, presyncope, muscle spasms, diarrhea, nausea, vomiting, abdominal pain, hypersalivation, and hyperhidrosis 1
- Exercise caution in patients receiving succinylcholine-type neuromuscular blocking agents, systemic anticholinergic medications, or non-depolarizing neuromuscular blocking agents 1
Clinical Context: Alternative First-Line Agents
Standard First-Line Therapy for uUTI
- For patients with renal or hepatic impairment who cannot receive gepotidacin, consider established first-line agents: 2
- Nitrofurantoin: Can be used cautiously in patients with eGFR as low as 30 mL/min with close monitoring for treatment failure and adverse effects 3
- Fosfomycin trometamol: 3 g single dose, recommended only in women with uncomplicated cystitis 2
- Trimethoprim-sulfamethoxazole: If local resistance patterns show E. coli resistance <20% 2
Treatment Duration
- Treat uncomplicated UTI episodes with as short a duration as reasonable, generally no longer than 7 days 2
- Gepotidacin's 5-day course aligns with this principle 1
Common Pitfalls to Avoid
- Do not assume gepotidacin is safe in severe renal or hepatic impairment simply because it is a newer agent—the FDA label explicitly contraindicates use in these populations 1
- Do not overlook concomitant medications that may interact via CYP3A4 inhibition or QTc prolongation, as these compound the risk in patients with borderline organ function 1
- Do not use gepotidacin in pregnant patients—it is indicated only for non-pregnant females ≥12 years old 1, 4
- Do not forget to obtain urine culture and sensitivity before treatment in patients with recurrent UTIs to guide appropriate antimicrobial selection 2