Side Effects and Precautions for Blujepa (Gepotidacin) in Adolescent Females with Liver or Kidney Disease
Critical Precautions Based on Organ Function
Avoid Blujepa entirely if this patient has severe renal impairment (eGFR <30 mL/min) or severe hepatic impairment (Child-Pugh Class C), as increased drug exposure significantly raises the risk of QTc prolongation. 1
Renal Disease Considerations
- No dose adjustment is required for mild renal impairment (eGFR 60-89 mL/min) or moderate renal impairment (eGFR 30-59 mL/min) 1
- Blujepa is substantially excreted by the kidney, making patients with impaired renal function at higher risk for adverse reactions 1
- Patients on dialysis should not receive Blujepa due to increased gepotidacin exposure and QTc prolongation risk 1
- Intermittent hemodialysis does not substantially remove Blujepa from systemic circulation 1
Hepatic Disease Considerations
- No dose adjustment needed for mild or moderate hepatic impairment (Child-Pugh Class A/B) 1
- Severe hepatic impairment (Child-Pugh Class C) is a contraindication due to increased drug exposure and QTc prolongation risk 1
Most Common Side Effects
Diarrhea is the most frequent adverse event with gepotidacin, occurring in 14-18% of patients in clinical trials, with most cases being mild to moderate 2
Gastrointestinal Side Effects
- Diarrhea: 14-18% of patients 2
- Nausea: less common than with comparator nitrofurantoin (4%) 2
- Most gastrointestinal adverse events were mild or moderate in severity 2, 3
Other Adverse Events
- No life-threatening or fatal events occurred in phase 3 uUTI trials 2
- No treatment-related severe or serious adverse events were observed 3
- The safety profile in female pediatric patients 12 years and older was similar to adults 1
Critical Drug Interaction Warning
Avoid concomitant administration with other medications that prolong the QTc interval due to increased risk of cardiac arrhythmias 1
- This is particularly important given the increased QTc prolongation risk in patients with severe renal or hepatic impairment 1
Pregnancy and Lactation Precautions
Pregnancy Considerations
- No available human data on Blujepa use in pregnant women 1
- Animal studies showed decreased fetal weights and increased late fetal resorptions at exposures 0.8-1 times the maximum recommended human dose 1
- A pregnancy exposure registry has been established; healthcare providers should report exposures to GlaxoSmithKline at 1-888-825-5249 1
Lactation Considerations
- Gepotidacin is likely transferred into human milk based on animal studies showing drug detection in nursing offspring 1
- The developmental and health benefits of breastfeeding should be weighed against potential adverse effects on the breastfed child 1
Monitoring Recommendations
No specific laboratory monitoring is mandated by the FDA label, but clinicians should assess renal and hepatic function before prescribing to ensure the patient does not have severe impairment 1
- Evaluate eGFR to determine renal function category 1
- Assess hepatic function using Child-Pugh classification if liver disease is present 1
- Consider baseline ECG if patient has risk factors for QTc prolongation or is taking other QTc-prolonging medications 1
Common Pitfalls to Avoid
- Do not prescribe Blujepa for patients with eGFR <30 mL/min or those on dialysis 1
- Do not use in severe hepatic impairment (Child-Pugh Class C) 1
- Do not combine with other QTc-prolonging medications without careful risk-benefit assessment 1
- Do not assume dose adjustment is needed for mild-moderate renal or hepatic impairment - standard dosing applies 1
Overdosage Management
QTc prolongation is the primary risk with overdosage 1