Orlynvah for bladder infection: four label and trial checks

Before filling an Orlynvah prescription, ask the prescriber to explain the organism, the available alternatives and the follow-up plan. The reason for choosing this medicine should be specific enough to write beside your urine-culture result.

Check the restricted indication

Orlynvah combines sulopenem etzadroxil and probenecid. Its U.S. indication covers adult women with uncomplicated UTIs from E. coli, K. pneumoniae or P. mirabilis and limited or no alternative oral antibiotics. Complicated UTIs, including oral treatment after intravenous therapy, are excluded.¹

Check who counted in the trial

REASSURE randomized 2,222 women; its culture-confirmed efficacy analysis included 990. Overall success required both clinical cure and microbiologic eradication at day 12. Success occurred in 318/522 (60.9%) with sulopenem/probenecid and 260/468 (55.6%) with amoxicillin/clavulanate.²

The 5.4-percentage-point difference (95% confidence interval −0.8 to 11.5) ruled out the trial’s predefined 10-percentage-point loss in success, without proving overall superiority. Diarrhea occurred in 8.1% versus 4.1%, respectively.²³

Check which susceptibility group a claim describes

Among participants whose bacteria were susceptible to amoxicillin/clavulanate, combined success favored Orlynvah: 61.7% versus 55.0%. Clinical cure alone was 77.3% versus 76.7%. The combined result did not establish a comparable symptom benefit.¹²

Only 67 participants had bacteria nonsusceptible to amoxicillin/clavulanate, too few to establish efficacy.¹

Check allergies and interacting medicines

The December 2025 label contraindicates ketorolac, known uric acid kidney stones, and hypersensitivity to its ingredients or other beta-lactam antibiotics. Bring medicine names and previous reaction details.¹

Write down the plan if symptoms change

Ask: “Why are the other oral options unsuitable, and who reviews my culture result if it arrives after I start treatment?” Keep the answer and the contact details with the prescription.

Fever and chills, back, side or groin pain, and nausea or vomiting can indicate kidney infection. NIDDK advises seeking care right away for kidney-infection symptoms.⁴

Our fosfomycin and nitrofurantoin comparison discusses different antibiotic trials. Laugh, Sneeze, Jump explains how to record burning, infection start dates and changing urgency together. Those dated notes can help when infections and ongoing bladder symptoms need discussion.