Blujepa

Drugs - Blujepa (gepotidacin) [GlaxoSmithKline LLC.]

August 2026

Therapeutic area - Uncomplicated urinary tract infection (UTI)

Approval criteria

  • The patient’s age and weight are appropriate according to a medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
  • Patient has ONE of the following diagnoses: 
    • Uncomplicated urinary tract infection (uUTI); AND 
      • The uUTI is caused by ≥ 1 of the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus or Enterococcus faecalis; OR
    • Uncomplicated urogenital gonorrhea; AND
      • has limited or no alternative treatment options; AND
  • Patient must NOT have hypersensitivity to any component of the product; AND
  • Patient does NOT have severe renal impairment or kidney failure (estimated glomerular filtration rate [eGFR] < 30 mL/min), including receipt of dialysis, due to the risk of increased drug levels and QTc prolongation; AND
  • Patient does NOT have severe hepatic impairment (Child-Pugh Class C) due to the risk of increased drug levels and QTc prolongation; AND
  • Prescriber has reviewed Blujepa Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate.

Quantity limits

  • uUTI: 20 tablets/5 days (1,500 mg [two 750 mg tablets] twice daily for 5 days) and may not be renewed
  • Uncomplicated Urogenital Gonorrhea: 8 tablets/course (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 and may not be renewed)

Background

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). 
  • 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. Approval of this indication is based on limited clinical safety data for this indication.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Blujepa and other antibacterial drugs, Blujepa should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Questions?

Provider Call Center: (844) 575-7887