Gepotidacin
BLUJEPA
What it isTriazaacenaphthylene inhibitor of bacterial DNA gyrase and topoisomerase IV; uncomplicated UTI and limited-option gonorrhea.
Why this oneUnlike gonorrhea-specific zoliflodacin, it also carries an uncomplicated-UTI indication.
What limits itQT prolongation and cholinergic effects matter; avoid susceptible arrhythmia patients and interacting CYP3A4 inhibitors.
FDA-approved for
- uncomplicated urinary tract infection (2025)
- uncomplicated gonorrhea (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Uncomplicated urinary tract infection (uUTI) | Females >=12 y and >=40 kg (adult and pediatric) | 1,500 mg (two 750 mg tablets) BID ~12 h apart x 5 days | Do not increase dose, extend duration, or shorten dosing interval (QTc risk) | |
| Uncomplicated urogenital gonorrhea | Adults and peds >=12 y, >=45 kg | 3,000 mg (four 750 mg tablets) PO once, then second 3,000 mg dose ~12 h later (total 2 doses) | Do not increase dose, extend duration, or shorten dosing interval (QTc risk) |
Renal Mild-moderate (eGFR 30-89): no adjustment. Avoid if eGFR <30 incl. dialysis (QTc risk from increased exposure). Gonorrhea + moderate renal impairment (eGFR 30-59): avoid if additional exposure risk factors present
Hepatic Mild-moderate (Child-Pugh A/B): no adjustment. Avoid in severe (Child-Pugh C). Gonorrhea + Child-Pugh B: avoid if additional exposure risk factors present
Repeat-dose spacing: doses approximately 12 hours apart (both indications)
Instructions
- Take after a meal to reduce GI intolerance
- Missed dose: take as soon as possible; for uUTI do not double up
Cautions
- QTc prolongation (dose/concentration-dependent) - avoid with history of QTc prolongation, relevant cardiac disease, antiarrhythmics/QT-prolonging drugs, strong CYP3A4 inhibitors, severe renal impairment (eGFR <30), or severe hepatic impairment (Child-Pugh C); if unavoidable, correct electrolytes and obtain ECG
- Gonorrhea patients: additionally avoid with moderate CYP3A4 inhibitors, or >=2 of: body weight 45-60 kg, moderate renal impairment (eGFR 30-59), moderate hepatic impairment (Child-Pugh B)
- Acetylcholinesterase inhibition - dysarthria, syncope, cholinergic effects; risk of AV block, bradycardia, bronchospasm, seizures; monitor patients with susceptible conditions or on succinylcholine-type/non-depolarizing neuromuscular blockers or systemic anticholinergics
- Hypersensitivity reactions incl. anaphylaxis - discontinue if allergic reaction
- Clostridioides difficile infection - evaluate if diarrhea develops
Adverse reactions
- uUTI (>=1%): diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, vulvovaginal candidiasis
- Gonorrhea (>=2%): diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, hyperhidrosis
Pregnancy No human data; animals: decreased fetal weights and late resorptions at exposures below MRHD, no malformations; pregnancy registry planned (GSK 1-888-825-5249)
Lactation No human data; likely present in milk (detected in nursing mouse pups' plasma); weigh benefits of breastfeeding against risk
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Gepotidacin ballicule
