AVIBACTAM/ AZTREONAM INJ,LYPHL
Clinical Criteria Summary
Indication
- In combination with metronidazole (MTZ) for adults who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible gram-negative bacteria
- Approval based on limited clinical safety and efficacy data
Dosing & Administration
- IV injection vial containing 1.5 g aztreonam and 0.5 g avibactam (total dose 2g)
- For CrCl > 50 mL/min: 2g IV every 6 hours, infused over 3 hours, following a loading dose of 2.67g
- Dose adjustments required for kidney dysfunction
Patient Selection & Clinical Context
- Likely limited to select patients with infections caused by difficult-to-treat gram-negative bacteria
- Generally managed by experts in Infectious Diseases and Antimicrobial Stewardship to ensure appropriate use
- Infections due to Enterobacterales producing metallo-beta-lactamases (MBLs) are uncommon in the US; typically seen in patients with extensive prior antibiotic exposure or international travel
- Less than 20% of carbapenem-resistant Enterobacterales (CRE) in the US produce MBL
- Can be used in patients with severe IgE-mediated cephalosporin allergy (other than ceftazidime)
Safety & Monitoring
- Most common adverse reactions: hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia
- ALT elevations > 5x the upper limit of normal occurred in 3.8% of patients
- Discontinuation due to elevated hepatic enzymes occurred in only 4 patients across development trials
- No unexpected adverse events noted
Preparation & Handling Requirements
- Must be administered over 3 hours every 6 hours
- Complicated preparation and possible drug wastage