WHA
 

Blujepa (gepotidacin)

Indications for Prior Authorization

Blujepa (gepotidacin)
  • For diagnosis of Uncomplicated Urinary Tract Infections
    Indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escheria coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis

  • For diagnosis of Uncomplicated Urogenital Gonorrhea
    Indicated in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms (kg) who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. Approval of this indication is based on limited clinical safety data for Blujepa.

Criteria

Blujepa

Prior Authorization

Length of Approval: 5 Day(s)
For diagnosis of Uncomplicated Urinary Tract Infection (uUTI)

  • Diagnosis of an uncomplicated urinary tract infection (uUTI)
    • AND
  • Patient is 12 years of age or older
    • AND
  • Patient weighs at least 40kg
    • AND
  • Trial and inadequate response, contraindication or resistance to one alternative oral antibacterial treatment option (e.g., nitrofurantoin, trimethoprim-sulfamethoxazole, ciprofloxacin)
    • AND
  • Infection is caused by one of the following: [A]
    • Escherichia coli
    • Klebsiella pneumoniae
    • Citrobacter freundii complex
    • Staphylococcus saprophyticus
    • Enterococcus faecalis
Blujepa

Prior Authorization

Length of Approval: 3 Days [B, 1]
For diagnosis of Uncomplicated Urogenital Gonorrhea

  • Diagnosis of uncomplicated urogenital gonorrhea susceptible to gepotidacin
    • AND
  • Patient is 12 years of age or older
    • AND
  • Patient weighs at least 45kg
    • AND
  • Trial and inadequate response, contraindication or resistance to one alternative antibacterial treatment option (e.g., IM ceftriaxone, oral azithromycin)

  • Guideline ID
    GL-483925

  • Formulary
    premium

  • Effective date
    Apr 1, 2026

  • P&T approval date
    Nov 20, 2025

P & T Revisions

2026-02-10, 2025-10-07

  1. Blujepa Prescribing Information. GlaxoSmithKline. December 2025.
  2. Wagenlehner F, Perry CR, Hooton TM, et al. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. Lancet. 2024;403(10428):741-755. doi:10.1016/S0140-6736(23)02196-7
  3. American Urological Association. Adult UTI. Available at: https://www.auanet.org/meetings-and-education/for-medical-students/medical-students-curriculum/adult-uti. Accessed June 27, 2025.
  4. Gupta K, Hooton TM, Naber KG, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120. doi:10.1093/cid/ciq257
  5. ClinicalTrials.gov. A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea. Available at: https://www.clinicaltrials.gov/study/NCT04010539?cond=NCT04010539&rank=1#publications. Accessed December 23, 2025.
  6. Ross, J., Wilson, J., Workowski, K., et al. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00628-2/abstract. Accessed December 23, 2025.
  7. Perry, C., Scangarella-Oman, N., Millns, H., et al. Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study. Available at: https://pubmed.ncbi.nlm.nih.gov/37751016/. Accessed December 23, 2025.
  8. WHO: Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (‎syphilis)‎ and new recommendations on syphilis testing and partner services. July 2024. Available at: https://www.who.int/publications/i/item/9789240090767. Accessed December 23, 2025.
  9. CDC: Clinical Treatment of Gonorrhea. July 2024. Available at: https://www.cdc.gov/gonorrhea/hcp/clinical-care/index.html. Accessed December 23, 2025.
  10. Barbee, L., and St Cyr, S. Management of Neisseria gonorrhoeae in the United States: Summary of Evidence From the Development of the 2020 Gonorrhea Treatment Recommendations and the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infection Treatment Guidelines. Available at: https://academic.oup.com/cid/article/74/Supplement_2/S95/6567961. Accessed December 23, 2025.
  1. Similar to other antibacterial drugs, gepotidacin should only be used to treat uncomplicated UTIs that are proven or strongly suspected to be caused by the approved susceptible bacteria in order to reduce the development of drug-resistant bacteria and maintain efficacy of gepotidacin. [1, 4]
  2. Blujepa comes as 750mg tablets. For the indication of uncomplicated urogenital gonorrhea, the recommended dose 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. The approval length of 3 days is to allow sufficient time for PA approval. [1]
  • 2026-02-10: update guideline for Blujepa - new indication of uncomplicated urogenital gonorrhea
  • 2025-10-07: New Program