Combination of | |
---|---|
Sulopenem | Penem antibacterial |
Probenecid | Renal tubular transport inhibitor |
Clinical data | |
Trade names | Orlynvah |
License data | |
Routes of administration | By mouth |
ATC code |
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Legal status | |
Legal status | |
Identifiers | |
KEGG |
Sulopenem/probenecid, sold under the brand name Orlynvah, is a fixed-dose combination medication used for the treatment of urinary tract infections. [1] It contains sulopenem, a penem antibacterial, as the prodrug sulopenem etzadroxil; and probenecid, a renal tubular transport inhibitor. [1]
The most common side effects include diarrhea, nausea, vaginal yeast infection, headache, and vomiting. [3]
The combination was approved for medical use in the United States in October 2024. [1] [3] [4] [5] [6]
Sulopenem/probenecid is indicated for the treatment of uncomplicated urinary tract infections 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. [1] [3]
Sulopenem/probenecid is contraindicated in people with a history of hypersensitivity reactions to sulopenem etzadroxil or probenecid or other beta-lactam antibacterial drugs; people with known blood dyscrasias; people with known uric acid kidney stones; and people who are also taking ketorolac tromethamine. [3]
The US Food and Drug Administration (FDA) prescribing information for sulopenem/probenecid includes warnings for hypersensitivity reactions, Clostridioides difficile-associated diarrhea, and potential exacerbation of gout when given to people with a known history of gout. [3]
The effectiveness of sulopenem/probenecid was evaluated in two phase III controlled, randomized, double blind clinical trials (trial 1 and trial 2) which enrolled adult women with uncomplicated urinary tract infections. [3] Trial 1 (NCT05584657) was a noninferiority trial in which 2214 adult women with uncomplicated urinary tract infections were randomized and treated. [3] Sulopenem/probenecid demonstrated efficacy in participants with amoxicillin/clavulanate-susceptible pathogens with a composite response rate (combined microbiological response and clinical response) of 62% compared to a composite response rate of 55% in the amoxicillin/clavulanate group. [3] Trial 2 (NCT03354598) was a noninferiority trial in which 1660 adult women with uncomplicated urinary tract infections were randomized and treated. [3] Sulopenem/probenecid demonstrated efficacy in participants with ciprofloxacin-resistant pathogens with a composite response rate of 48% compared to a composite response rate of 33% in the ciprofloxacin group. [3] Overall, in the two trials combined, 1932 participants were treated with sulopenem/probenecid. [3] Clinical trials evaluating sulopenem/probenecid for the treatment of participants with complicated urinary tract infections and complicated intra-abdominal infections did not demonstrate effectiveness. [3]