What is the name of the drug and what does it do?
Orlynvah (pronounced OR-lin-vah), a combination of sulopenem etzadroxil and probenecid, is a medication used to treat uncomplicated urinary tract infections (uUTIs) in adult women. It is specifically prescribed when there are limited or no alternative oral antibiotics available. Orlynvah targets bacterial infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Orlynvah Was Approved on October 25, 2024
How does it work?
Orlynvah combines two active ingredients to fight infections. Sulopenem etzadroxil is an antibiotic that stops bacteria from forming their protective cell walls, effectively killing them. Probenecid helps keep sulopenem in the body longer by preventing it from being cleared by the kidneys too quickly. Together, they work to treat uUTIs more effectively.
What did the research discover?
Clinical trials compared Orlynvah to other antibiotics in over 4,000 women with uUTIs.
- In one trial, Orlynvah showed a 61.7% success rate in treating infections caused by bacteria sensitive to its active ingredients, compared to 55% for amoxicillin/clavulanate.
- In another trial, Orlynvah demonstrated a 48.1% success rate in treating infections caused by bacteria resistant to ciprofloxacin, compared to 32.9% for ciprofloxacin itself.
These studies highlight Orlynvah’s effectiveness, especially in patients with resistant infections or limited treatment options.
What are some of the side effects?
The most common side effects of Orlynvah include:
- Diarrhea
- Nausea
- Headache
- Vaginal yeast infections
- Vomiting
Less common but serious side effects include allergic reactions, Clostridioides difficile-associated diarrhea (severe gut infection), and worsening gout symptoms. Patients should inform their doctor if they experience severe side effects, such as hives, difficulty breathing, or prolonged diarrhea.
What are the dosage recommendations and how is it prescribed?
The recommended dose of Orlynvah is one tablet, taken twice daily with food, for 5 days. Each tablet contains 500 mg of sulopenem etzadroxil and 500 mg of probenecid.
If a dose is missed, patients should take it as soon as possible, but not double up on doses. The medication is not recommended for patients with severe kidney problems, those with known uric acid kidney stones, or those taking certain medications like ketorolac.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 213972]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213972s000lbl.pdf. Accessed 2024 Nov 21.
