DURLOBACTAM/ SULBACTAM INJ,LYPHL
Clinical Criteria Summary
Indication & Patient Population
- • Indicated for patients 18 years of age and older
- • Indicated for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)
- • Must be caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
Dosing & Renal Adjustments
- • Recommended dose: 1g sulbactam and 1g durlobactam administered intravenously every 6 hours over a 3-hour infusion
- • Dose adjustments required for estimated creatinine clearance (CrCl) < 45 mL/min or > 130 mL/min
- • CrCl > 130 mL/min: Decrease dosing interval to every 4 hours
- • CrCl 30–44 mL/min: Increase dosing interval to every 8 hours
- • CrCl 15–29 mL/min: Increase dosing interval to every 12 hours
- • CrCl < 15 mL/min: Administer every 12 hours for 3 doses, then switch to every 24 hours
Susceptibility & Microbiological Criteria
- • Susceptibility testing must be used to guide treatment, particularly in strains resistant to sulbactam alone
- • Not active against Acinetobacter baumannii producing Ambler class B metallo-beta-lactamases or possessing PBP3 target site alterations
- • Approximately 3–6% of isolates may be nonsusceptible based on global surveys and clinical trial screening
Contraindications & Safety Monitoring
- • Contraindicated in patients with known hypersensitivity to the components of sulbactam/durlobactam
- • Monitor for hypersensitivity reactions and C. difficile associated diarrhea
Place in Therapy & Usage Guidelines
- • Likely most beneficial when the isolate is not susceptible to sulbactam AND no other active agent can be used in combination due to resistance or tolerability concerns, OR in patients failing ampicillin/sulbactam-based combination therapy
- • Infectious Diseases experts should be involved in prescribing decisions to prevent overuse and development of resistance
- • Limited safety database currently exists; hypersensitivity reactions were observed in clinical trials