IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- ORLYNVAH is contraindicated in patients with a history of hypersensitivity to ORLYNVAH components or other beta-lactam antibacterial drugs, known blood dyscrasias, and known uric acid kidney stones.
- Concomitant use with ketorolac tromethamine is contraindicated.
WARNINGS AND PRECAUTIONS
- Hypersensitivity Reactions: Serious, severe, and potentially fatal allergic reactions, including angioedema, anaphylaxis, and skin reactions, have been reported with ORLYNVAH, probenecid (a component of ORLYNVAH), or other beta-lactams. Screen for prior beta-lactam hypersensitivity before starting ORLYNVAH. Discontinue ORLYNVAH immediately if an allergic reaction occurs and initiate appropriate treatment.
- Clostridioides difficile-Associated Diarrhea (CDAD): CDAD, ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents. Consider CDAD in patients with diarrhea following antibacterial use. If CDAD is suspected or confirmed, discontinue antibacterial use not directed against C. difficile, if possible, and provide appropriate treatment.
- Uric Acid Kidney Stones / Exacerbation of Gout: ORLYNVAH may cause or worsen uric acid kidney stones and gout. In patients with a history of gout, ensure appropriate management to reduce these risks.
- Development of Drug-Resistant Bacteria: Use ORLYNVAH only to treat proven or suspected susceptible uUTIs. Incomplete courses may decrease effectiveness and increase resistance.
ADVERSE REACTIONS
- The most common adverse reactions (≥2%) in patients receiving ORLYNVAH were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
DRUG INTERACTIONS
- Probenecid (a component of ORLYNVAH) may increase plasma concentrations of drugs dependent on OAT1/3 for elimination. Other potentially significant drug interactions with probenecid include:
- Ketorolac tromethamine: Contraindicated.
- Ketoprofen: Use not recommended.
- Indomethacin, Naproxen: May increase adverse reactions; consider dose adjustment per drug-specific prescribing information.
- Methotrexate, Rifampin: Monitor more frequently for drug-specific adverse reactions if concomitant use cannot be avoided.
- Lorazepam: Adjust dose per its prescribing information.
- Oral Sulfonylureas: Monitor more frequently for hypoglycemia and adjust dose per its prescribing information.
- Potential for Other Drugs to Affect ORLYNVAH: Sulopenem (a component of ORLYNVAH) is a substrate of OAT3; therefore, drugs that inhibit OAT3 may increase sulopenem plasma concentrations. If used together, monitor more frequently for adverse reactions.
- Drug/Laboratory Interactions: ORLYNVAH may interfere with copper sulfate urine glucose tests, resulting in false-positive readings for glycosuria. Confirm with a glucose-specific test. Falsely high readings for theophylline have been reported in an in vitro study.
USE IN SPECIFIC POPULATIONS
- Renal Impairment: No dosage adjustment is required in patients with CrCL ≥15 mL/min. ORLYNVAH is not recommended in patients with CrCL <15 mL/min and those on hemodialysis.
To report SUSPECTED ADVERSE REACTIONS, contact Iterum Therapeutics at 1-866-414-SULO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for more information about ORLYNVAH
INDICATION
ORLYNVAH is for the treatment of uncomplicated urinary tract infections (uUTIs) caused by E coli, K pneumoniae, or P mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
Limitations of Use: ORLYNVAH is not indicated for the treatment (or step-down treatment after IV antibacterial treatment) of complicated UTIs or complicated intra-abdominal infections.
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, ORLYNVAH should be used only to treat uUTIs 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.