Orlynvah™

Drug - Orlynvah™ (sulopenem etzadroxil and probenecid) [Iterum Therapeutics plc]

May 2026

Therapeutic Area - Cephalosporins and Related Antibiotics

Approval criteria

  • The patient’s age is within FDA labeling for the requested indication for the requested agent AND
  • Diagnosis of uncomplicated urinary tract infection (uUTI) based on signs and symptoms attributable to uUTI (e.g., urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain); AND
  • Infection is proven or strongly suspected to be caused by at least one of the following organisms: Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis; AND
  • Patient has tried and had an inadequate response or contraindication or intolerance to first-line therapy or alternatives (e.g., nitrofurantoin, trimethoprim/sulfamethoxazole, fosfomycin, amoxicillin/clavulanic acid, ciprofloxacin, levofloxacin); AND
  • Orlynvah will NOT be used for complicated urinary tract infections (cUTI) or as step-down treatment after intravenous (IV) antibacterial treatment of cUTI; AND
  • Orlynvah will NOT be used for complicated intra-abdominal infections (cIAI) or as step-down treatment after IV antibacterial treatment of cIAI; AND
  • Patient does NOT have history of uric acid kidney stones; AND
  • Patient does NOT have history of blood dyscrasias; AND
  • Patient is NOT on concomitant ketorolac tromethamine therapy and will not receive ketorolac tromethamine while on Orlynvah; AND
  • Patient does NOT have a history of hypersensitivity (e.g., angioedema, anaphylaxis, serious skin reactions) to beta-lactams, probenecid or any component of the product; AND
  • Prescriber has reviewed Orlynvah Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate.

Quantity limits

  • 10 tablets per 5-day course and may not be renewed

Background

Orlynvah, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in patients who have limited or no alternative oral antibacterial treatment options.

Orlynvah is NOT indicated for the treatment of:  

  • Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. 
  • Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous antibacterial treatment of cIAI. 

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Orlynvah and other antibacterial drugs, Orlynvah should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy.

Questions

Provider Call Center: (844) 575-7887