Tebipenem

UTEBZI is a penem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options. Usage to Reduce Development of Drug ‑ Resistant Bacteria To reduce the development of drug‑resistant bacteria and maintain the effectiveness of UTEBZI and other antibacterial drugs, UTEBZI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Tebipenem pivoxil is a prodrug of tebipenem, an antibacterial drug.

• The recommended dosage of UTEBZI is 600 mg (two 300 mg tablets) taken orally every 6 hours for 7 to 10 days in adult patients with an eGFR between 60 and 150 mL/min. • Do not use UTEBZI beyond the recommended treatment duration. • UTEBZI can be taken with or without food. • The recommended dosage for patients with renal impairment is shown below. Estimated Glomerular Filtration Rate (eGFR) Dose Frequency 60 mL/min to less than 90 mL/min 600 mg Every 6 hours 30 mL/min to 59 mL/min 300 mg Every 6 hours 15 mL/min to 29 mL/min 300 mg Every 12 hours

UTEBZI is contraindicated in patients with hypersensitivity to UTEBZI or other beta‑lactam antibacterial drugs. UTEBZI is contraindicated in patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. • In patients with hypersensitivity to UTEBZI or other beta-lactam antibacterials. • In patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

• Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactam and carbapenem antibacterials. Discontinue UTEBZI if a hypersensitivity reaction occurs. • Seizures and Other Central Nervous System (CNS) Adverse Reactions: Seizures and other CNS adverse reactions have been reported in patients receiving therapy with beta-lactam and carbapenem antibacterials, including UTEBZI. If CNS adverse reactions including seizures occur, evaluate neurologically to determine whether UTEBZI should be discontinued. • Concomitant use of UTEBZI with valproic acid or divalproex sodium may reduce the serum concentration of these drugs potentially increasing the risk of breakthrough seizures. Avoid concomitant use of UTEBZI with valproic acid or divalproex sodium.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions. • Seizures and Other CNS Adverse Reactions. • Carnitine Depletion. • Clostridioides difficile Infection (CDI). The most common adverse reactions occurring in ≥1% of patients are diarrhea, headache, nausea, abdominal pain, hepatic enzyme increased, and Clostridioides difficile infection.

• Organic Anion Transporter 1 (OAT1) and 3 (OAT3) inhibitors: OAT1 and OAT3 inhibitors (e.g., probenecid) increase the plasma concentration of tebipenem. If concomitant use with UTEBZI is necessary, monitor more frequently for adverse reactions associated with UTEBZI (e.g., diarrhea and headache).

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°).