Emblaveo Aztreonam and Avibactam Sodium for Injection

1. Indications and Usage
Complicated Intra-Abdominal Infections (cIAI):
Indicated for the treatment of adult patients with cIAI caused by susceptible isolates of Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Enterobacter cloacae complex, Citrobacter freundiicomplex, Serratia marcescens, and Proteus mirabilis.
Hospital-Acquired Pneumonia (HAP):
Indicated for the treatment of adult patients with HAP, including Ventilator-Associated Pneumonia (VAP), caused by susceptible isolates of K. pneumoniae, Enterobacter cloacae complex, E. coli, S. marcescens, K. aerogenes, Stenotrophomonas maltophilia, P. mirabilis, and Morganella morganii.
2. Dosage and Administration
Recommended Dosage (Adults with eCrCL > 50 mL/min):
Dose: Aztreonam 1.5 g / Avibactam 0.5 g (or Aztreonam 2 g / Avibactam 0.67 g).
Frequency: Every 6 hours.
Infusion Time: Administer as a 3-hour intravenous infusion.
Renal Impairment:
Dosage adjustment is required for patients with an estimated creatinine clearance (eCrCL) ≤ 50 mL/min.
Administration:
Administer via intravenous infusion only. Do not admix with other drugs.
3. Mechanism of Action
Aztreonam (Antibiotic):
A monobactam that binds to Penicillin-Binding Proteins (PBPs), inhibiting bacterial cell wall synthesis and causing cell lysis. It is stable against most β-lactamases, including Metallo-β-lactamases (MBLs).
Avibactam (Inhibitor):
A non-β-lactam β-lactamase inhibitor that inhibits Ambler Class A (e.g., KPC, ESBLs), Class C (AmpC), and certain Class D (e.g., OXA-48) β-lactamases, thereby protecting aztreonam from degradation.
4. Safety and Warnings
Hypersensitivity Reactions:
Hypersensitivity reactions may occur.
Seizures:
Neurotoxicity, including seizures, may occur, particularly in patients with renal impairment or those receiving high doses.
Laboratory Interference:
Avibactam may cause false-positive results in certain urine glucose tests (e.g., Clinitest).
5. Adverse Reactions
Most Common:
Anemia (6.9%), diarrhea (6.2%), increased alanine aminotransferase (ALT) (6.2%), and increased aspartate aminotransferase (AST) (5.2%).
6. Drug Interactions
Probenecid:
Probenecid may inhibit the renal excretion of aztreonam and avibactam, leading to increased exposure. Concurrent use is not recommended.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredients: Aztreonam and Avibactam Sodium.
Storage:
Store below 30°C. Protect from light.