Gepotidacin

BLUJEPA is an antibacterial drug [see Microbiology ( 12.4 )] .

• BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options.ICD-10: N39.0

• BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA.contraindicated

• uUTI: The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart), for 5 days. ( 2.1 ) • Uncomplicated Urogenital Gonorrhea: The recommended dosage of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later. ( 2.2 ) • Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance. ( 2.3 ) 2.1 Recommended Dosage for Female Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg for Uncomplicated UTI The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart) for 5 days in female adult and pediatric patients 12 years of age and older with uncomplicated uUTI [see Dosage and Administration ( 2.3 )] . 2.2 Recommended Dosage for Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 45 kg for Uncomplicated Urogenital Gonorrhea The recommended dose of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later in adult and pediatric patients 12 years of age and older weighing at least 45 kg with uncomplicated urogenital gonorrhea [see Dosage and Administration ( 2.3 )]. Do not increase the dose, extend the duration of treatment, or reduce the interval between doses due to the risk of QTc interval prolongation [see Warnings and Precautions ( 5.1 )].

• QTc Prolongation: • Avoid use of BLUJEPA in patients with a history of QTc prolongation, or with relevant pre‑existing cardiac disease, or in patients receiving drugs that prolong the QTc interval. ( 5.1 ) • Due to an increase in gepotidacin exposure and the risk of QTc interval prolongation, avoid use of BLUJEPA in patients who have any of the following risk factors: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of strong CYP3A4 inhibitors • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min) • Severe hepatic impairment (Child-Pugh Class C) • Additionally, avoid BLUJEPA in uncomplicated urogenital gonorrhea patients, who have any of the following risk factors for increased gepotidacin exposure: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of moderate CYP3A4 inhibitors • Two or more of the following risk factors: Body weight between 45 kilograms and 60 kilograms, Moderate renal impairment (eGFR 30 to 59 mL/min), Moderate hepatic impairment (Child-Pugh Class B) • Acetylcholinesterase Inhibition: Dysarthria and other adverse reactions have been reported in patients receiving BLUJEPA. Monitor patients with underlying medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine‑type neuromuscular blocking agents, systemic anticholinergic medications, or non‑depolarizing neuromuscular blocking agents. ( 5.2 ) • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving BLUJEPA.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • QTc Prolongation [see Warnings and Precautions ( 5.1 )] . • Acetylcholinesterase Inhibition [see Warnings and Precautions ( 5.2 )] . • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . • Clostridioides difficile Infection [see Warnings and Precautions ( 5.4 )] . • uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis. ( 6.1 ) • Uncomplicated Urogenital Gonorrhea: The most common adverse reactions occurring in ≥2% of patients are diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Patients with Uncomplicated UTI The safety of BLUJEPA was evaluated in 2 double‑blind, active‑controlled, randomized trials in female adult and pediatric patients 12 years of age and older with uUTI (Trial 1 and Trial 2).

• Renal Impairment: Avoid use of BLUJEPA in patients with severe renal impairment with eGFR <30 mL/min, including those receiving dialysis. ( 8.6 ) • Hepatic Impairment: Avoid use of BLUJEPA in patients with severe hepatic impairment (Child-Pugh Class C). ( 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry will be established to monitor pregnancy outcomes in women exposed to BLUJEPA during pregnancy. Pregnant women exposed to BLUJEPA, and healthcare providers are encouraged to contact GlaxoSmithKline at 1‑888‑825‑5249. Risk Summary There are no available data on the use of BLUJEPA in pregnant women to evaluate for a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In embryo‑fetal development studies in mice and rats, decreased fetal weights and increased fetal mortality (late resorptions) were observed at exposures less than the maximum recommended human dose (MRHD). In a mouse pre- and postnatal development study, there were no adverse developmental effects at exposures approximately equal to the MRHD (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Pharmacokinetic Parameters The pharmacokinetic properties of gepotidacin are summarized in Table 4 as mean (standard deviation [SD]) unless otherwise specified. Table 4.

There is a risk of QTc prolongation with overdosage. Intermittent hemodialysis is not likely to substantially remove BLUJEPA from the systemic circulation. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.

• Mar 25, 2025NDANDA218230Glaxosmithkline

1. 1Diarrhoea229%
2. 2Drug Ineffective114%
3. 3Drug Intolerance114%
4. 4Dysarthria114%
5. 5Dysuria114%
6. 6Intercepted Product Prescribing Error114%
7. 7Irritable Bowel Syndrome114%
8. 8Off Label Use114%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Gepotidacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
  Not yet recruiting · Phase 1 · Interventional · 8 enrolled · GlaxoSmithKline
  NCT07645235updated 2026-06-12
• A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
  Not yet recruiting · Phase 1 · Interventional · 20 enrolled · GlaxoSmithKline
  NCT07371429updated 2026-04-23
• A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
  Completed · Phase 3 · Interventional · 97 enrolled · GlaxoSmithKline
  NCT06597344updated 2026-02-11
• A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
  Completed · Phase 3 · Interventional · 380 enrolled · GlaxoSmithKline
  NCT05630833updated 2025-03-17
• Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue
  Completed · Phase 1 · Interventional · 53 enrolled · Institut National de la Santé Et de la Recherche Médicale, France
  NCT04484740updated 2025-02-20
• A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
  Completed · Phase 3 · Interventional · 628 enrolled · GlaxoSmithKline
  NCT04010539updated 2024-05-30
• Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
  Completed · Phase 3 · Interventional · 1,606 enrolled · GlaxoSmithKline
  NCT04187144updated 2023-07-18
• A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
  Completed · Phase 3 · Interventional · 1,531 enrolled · GlaxoSmithKline
  NCT04020341updated 2023-06-22
• A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants
  Completed · Phase 1 · Interventional · 24 enrolled · GlaxoSmithKline
  NCT05271799updated 2023-01-30
• Drug-drug Interaction Study of Gepotidacin
  Completed · Phase 1 · Interventional · 64 enrolled · GlaxoSmithKline
  NCT04493931updated 2022-03-04

Frequently asked questions

How does Gepotidacin work?

BLUJEPA is an antibacterial drug [see Microbiology ( 12.4 )] .

What is Gepotidacin used for?

According to FDA labeling, Gepotidacin carries indications including: BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gepotidacin?

Gepotidacin is classified as Other antibacterials, Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, Cholinesterase Inhibitors, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Topoisomerase 2 Inhibitors, Topoisomerase 4 Inhibitors.

What are the brand names for Gepotidacin?

Gepotidacin is marketed under brand names including Blujepa.

What are the contraindications for Gepotidacin?

Gepotidacin labeling lists contraindications including: BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA.. Always consult the full prescribing information and a clinician.