GSK Blujepa (gepotidacin) Monograph

Blujepa (gepotidacin) is a triazaacenaphthylene bacterial type II topoisomerase inhibitor that was first approved by the U.S. Food and Drug Administration (FDA) in March 2025 for the treatment of female adults and pediatric patients 12 years and older with uncomplicated urinary tract infections. Blujepa received an additional FDA approval in December 2025 as a treatment option for uncomplicated urogenital gonorrhea for adult and pediatric patients 12 years and older.

Read on to learn more about Blujepa, including its warnings and precautions, drug interactions, and more.

Medication Overview:

• Brand Name: Blujepa
• Generic Name: Gepotidacin
• Treatment for: Uncomplicated urinary tract infections and uncomplicated urogenital gonorrhea
• Manufacturer(s): GSK
• Initial FDA Approval: March 2025

Warnings and Precautions:

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.
• 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: 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: 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.

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving Blujepa. If an allergic reaction to Blujepa occurs, discontinue the drug and institute appropriate supportive measures.

Clostridioides Difficile Infection (CDI): CDI has been reported with nearly all systemic antibacterial agents, including Blujepa. Evaluate patients who develop diarrhea.

Dosage and Administration:

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. 

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.

Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance.

Contraindications:

A history of severe hypersensitivity to Blujepa.

Drug Interactions:

• CYP3A4 Inhibitors: Increase gepotidacin exposure.
  • Strong CYP3A4 inhibitors: Avoid concomitant use of Blujepa with strong CYP3A4 inhibitors.
  • Moderate CYP3A4 inhibitors: Avoid concomitant use of Blujepa with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea.
• CYP3A4 Inducers: Decrease gepotidacin exposure.
  • For uUTI: Avoid concomitant use of Blujepa with strong CYP3A4 inducers.
  • For uncomplicated urogenital gonorrhea: Avoid concomitant use of Blujepa with strong and moderate CYP3A4 inducers
• CYP3A4 Substrates: Avoid concomitant use of Blujepa with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions.
• Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of Blujepa. 

Adverse Reactions:

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.

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.

Please note: This article is current as of May 7, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

Sign up for alerts to keep up with the latest clinical guidelines and guideline updates.