Imipenem/cilastatin/relebactam

FDA

• Treatment of the following infections caused by susceptible Gram-negative bacteria in adults and pediatric patients weighing ≥ 2 kg:
  • Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
  • Treatment of complicated urinary tract infections, including pyelonephritis (cUTI*) in patients who have limited or no alternative treatment options.
  • Complicated intra-abdominal infections (cIAI*) in patients who have limited or no alternative treatment options.

*Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data.

NON-FDA APPROVED USES

• Treatment of susceptible KPC-producing Enterobacterales (KPC-E) and DTR P. aeruginosa infections outside FDA-approved indications (e.g., bacteremia, osteomyelitis).