Generic name: sulopenem etzadroxil and probenecid
Dosage form: Tablet (sulopenem etzadroxil 500 mg, probenecid 500mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 30, 2024.

What is Orlynvah?

Orlynvah tablets are used to treat uncomplicated urinary tract infections (uUTI) caused by specific bacteria, in adult women with limited other antibacterial options. Orlynvah contains sulopenem etzadroxil, a penem antibiotic, and probenecid which increases blood concentrations of sulopenem. Sulopenem belongs to the penem class of antibacterials which works against bacteria infections resistant to specific antibiotics.

Orlynvah FDA approval is for the treatment of uncomplicated urinary tract infections caused by the bacteria Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.  FDA approval was based on positive results of Phase 3 clinical trial SURE 1 which compared Orlynvah to ciprofloxacin, and REASSURE which compared Orlynvah with Augmentin (amoxicillin/clavulanate) in adult women with uUTI.

Orlynvah should not be used for complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. It should not be used for complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous antibacterial treatment of cIAI. 

How does Orlynvah work?

Orlynvah contains sulopenem etzadroxil (a prodrug), which is converted into sulopenem, the active antibacterial after oral administration.

Orlynvah has two mechanisms of action: sulopenem etzadroxil, gets converted in the body into sulopenem, the active antibacterial. The Probenecid mechanism of action is by reducing the kidney clearance of sulopenem, this increases the blood concentrations of sulopenem, making it more effective at improving the uUTI.

What is an uncomplicated urinary tract infection?

Uncomplicated urinary tract infection are infections bladder or lower urinary tract that occur in women without any structural abnormality of the urinary tract and no other health issues such as diabetes, an immunocompromised state, recent urologic surgery, or pregnancy. Symptoms of an uUTI are increased urinary frequency, urgency, suprapubic discomfort, and painful urination. 

Complicated UTI are any urinary tract infection in males, patients that are immunocompromised, pregnant patients, and patients with fevers, stones, sepsis, urinary obstruction, catheters, or infection that involves the kidneys.

Orlynvah side effects

Common Orlynvah side effects

Common Orlynvah side effects are diarrhea (10%), nausea (4%), vulvovaginal fungal infection (2%), headache (2%), and vomiting (2%). These side effects occurred in 2% or more of patients in clinical trials.

Serious side effects

Orlnyvah side effects that caused patients to discontinue tablets included nausea (0.3%), diarrhea (0.3%), as well as abdominal pain, gastroesophageal reflux disease, vomiting, and dizziness, each 0.2%. 

Allergic reactions, including serious allergic reactions, could occur with this medicine, serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to Orlynvah, other beta-lactam antibacterial drugs or probenecid.

Also, see the Warnings section.

Related/similar drugs

Warnings

Hypersensitivity Reactions: Hypersensitivity reactions have been reported in patients treated with Orlynvah. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with beta-lactam antibacterial drugs. Severe allergic reactions and anaphylaxis have been reported with the use of probenecid (an active ingredient in this medicine). If an allergic reaction occurs, discontinue the drug and immediately start appropriate therapy. 

Clostridioides difficile-Associated Diarrhea (CDAD): Advise patients that diarrhea is a common problem caused by antibacterial drugs, including this medicine, and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur, which may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider.

Exacerbation of Gout: Probenecid (an active ingredient in this medicine) may cause gout flare-up in patients with a known history of gout. These patients should have appropriate gout therapy started.

Also, see the side effects section.

Who should not take Orlynvah?

You should not take Orlynvah if you have:

• a history of hypersensitivity to the components of Orlynvah (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs 
• known blood dyscrasias.  
• uric acid kidney stones. 

You should not take Orlynvah if you are taking ketorolac tromethamine. 

Using Orlynvah with ketoprofen is not recommended.

Before taking this medicine

Tell your doctor if you have a history of:

• allergy to Orlynvah, its active ingredients sulopenem etzadroxil and probenecid, other beta-lactam antibacterial medicines, or any inactive ingredients in this medicine.
• gout
• uric acid kidney stones
• known blood dyscrasias

Pregnancy and breastfeeding

Tell your healthcare provider if you are planning a pregnancy, pregnant, or breastfeeding so that you and your healthcare provider can make an informed decision on your treatment options.

How should I take Orlynvah?

Orlynvah tablets are taken twice daily, with food. Complete the full course to reduce the risk of antibacterial resistance.

Orlynvah dosing information

The recommended Orlynvah dose is one tablet (500 mg sulopenem etzadroxil and 500 mg probenecid) twice daily.

Dose in renal impairment. Orlynvah is not recommended in patients with creatinine clearance (CrCL) less than 15 mL/min or patients on hemodialysis. No dosage adjustment is required for patients with CrCL greater than or equal to15 mL/min.

What happens if I miss a dose?

If a dose is missed,  take the dose as soon as possible. Do not double the dose to make up for the missed dose.

What other drugs will affect Orlynvah?

Other drugs may interact with Orlynvah, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Taking Orlynvah with ketoprofen is not recommended.
• Do not take Orlynvah with ketorolac tromethamine. 
• Probenecid (one of the active ingredients in this medicine) is an inhibitor of organic anion transporters 1 and 3 (OAT1/3) and may increase plasma concentrations of drugs that are dependent on OAT1/3 for elimination. 
• Sulopenem is a substrate of OAT3 so drugs that inhibit OAT3 may increase sulopenem plasma concentrations. If using Orylnvah with a drug that inhibits OAT3  is necessary, monitor more frequently for adverse reactions associated with Orlynvah (e.g., diarrhea and nausea).

Storage

Store tablets at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).

Ingredients

Active ingredients: sulopenem etzadroxil  500 mg and probenecid 500 mg 

Inactive tablet ingredients: croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. 

Film coating ingredients: carmine, lecithin polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. 

Manufacturer

Orlynvah manufacturer Iterum Therapeutics U.S. Limited, Chicago, IL 60606 US.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer