WHA

Orlynvah (sulopenem etzadroxil and probenecid)

Indications for Prior Authorization

Orlynvah (sulopenem etzadroxil and probenecid)
  • For diagnosis of Uncomplicated Urinary Tract Infections
    Indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Criteria

Orlynvah

Prior Authorization

Length of Approval: 5 Day(s)

  • Diagnosis of an uncomplicated urinary tract infection (uUTI)
    • AND
  • Patient is 18 years of age or older
    • AND
  • Trial and inadequate response, contraindication or resistance to one alternative oral antibacterial treatment option (e.g., trimethoprim-sulfamethoxazole, ciprofloxacin)
    • AND
  • Infection with one of the following: [B]
    • Escherichia coli
    • Klebsiella pneumoniae
    • Proteus mirabilis

  • Guideline ID
    GL-308214

  • Formulary
    Premium

  • Effective date
    Sep 1, 2025

  • P&T approval date
    Aug 21, 2025

P & T Revisions

1970-01-01

  1. Orlynvah Prescribing Information. Iterum Therapeutics U.S. Limited. March 2025.
  2. CliinicalTrials.gov. Oral Sulopenem Versus Amoxicillin/​Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (REASSURE). Available at: https://clinicaltrials.gov/study/NCT05584657?cond=NCT05584657&rank=1#participation-criteria. Accessed June 27, 2025.
  3. CliinicalTrials.gov. Oral Sulopenem-etzadroxil/​Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women. Available at:https://clinicaltrials.gov/study/NCT03354598?cond=NCT03354598&rank=1#participation-criteria. Accessed June 27,2025.
  4. Baker, D., and Levien, T. Sulopenem Etzadroxil/Probenecid. Hosp Pharm. March 2025. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11907500/. Accessed June 27, 2025.
  5. 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.
  6. Gupta, K., Hooton, T., Naber, K., 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. Available at: https://watermark.silverchair.com/ciq257.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA3IwggNuBgkqhkiG9w0BBwagggNfMIIDWwIBADCCA1QGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMArQr0N-nx3RZWgznAgEQgIIDJd2VADt5cvTLUTzDMVUcEegNN6NdL1qVqK5SXA-m_ASexiE5oI0XL5XBtmSHNSDpJFh8KU5OLIDoOrc-y4QxpXfefynLtHAegyb9sCyZNWca6mDM3mZuqX82d7bGkgjMcDYRx_cSO6_Pe9HDfiTCrIFBmPcNHC9w6es1sE9S191DIoiX6i8rTiE2Q5kkUTXQRhOkU-epgT_ZhaTCblQfruLMmtWr-oYLPKvJcH7TkJdWCrsp4llBOpdmnOVpF2hQ6t-X_LbvXeleZgYCqtejzoHzasBlMiCktcJIuhDRzQWqjy8aV4vaSc3ugKtQ_e6bpCbEwixbJPjctsaiKGfF2Jg-Hu3DSASJgF-jsMCjIl3D0xWaInclRPbcLuBWhIamk1Sx63G6K4tOEgmXxtd5MW5YEF0tMwzwrhs56LUFY_WNS7nuagXh6kEG05HXPSc_0y7dQFfjKuTfdwR6BN2Bjon2EeGMqEzS8G3EcJn1wrcn2JRBL2Kyjv46ltz10NbNvmKlO1mBEM3ZFQX51HQbfLgelGgjHB-uZ9qNLSrbI0bpP7d8Va-UGsHm_TMVPxnEE5fVu1EE9Cz86c1cAIi5JS1tu3ndGLlmymb_A9m7qIlFqjPvkrnyagcLRNlym359Cs0Eddnka2OHgLdRRNYWpc3mrUjTmduk2yBrBrENOQ7vXVP97rCJhdJbL2cbxj3zKa-rha4k4ANYNfc4de9YijmagXpqsIJBJB67pP2drzsQgghZEdP9t4LDh2em4CMImGZgUidCQKGMwk13wu9FTujFoPXRNRBjl07_uE82fvk8e33HfsH0XLLws6gJJszO0uJeBp0q5nkGmP7eftcqKHdOliqrm8pjMzuAQJAtp9ojiIcs-X8WMi19GI9wuTAdBEn_1FMj3-ZtRRkWxG6aYjwmRhrmuxjUtlZQYZzoBEkjWR3gC9NNAIOHs2gSpq-XSyM84XwWpzYv07J2VrAqCaTYPMS2r2xeade6uUU2aIIyuFzAAnbllXJr4bq1cBiIVEWcS9ilZAd2WGtby6GdE4w3FeEzMD9xhRztKs8XmRN7reu-tXg. Accessed June 27, 2025.
  7. Nelson, Z., Aslan, A., Beahm, N., et al. Guidelines for the Prevention, Diagnosis, and Management of Urinary Tract Infections in Pediatrics and Adults. Available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2825634. Accessed June 27, 2025.
  8. Bono, M., and Leslie, S. Uncomplicated Urinary Tract Infections. Available at: https://www.ncbi.nlm.nih.gov/books/NBK470195/. Accessed June 27, 2025.
  1. Both clinical trials' inclusion criteria, showing urinalysis with dipstick positive test for leukocyte esterase or nitrite and evidence of pyuria showing at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine [2-3]
  2. Similar to other antibacterial drugs, sulopenem etzadroxil/probenecid 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 sulopenem etzadroxil/probenecid. [1, 4]