General Information

Xacduro contains sulbactam, a beta-lactam antibacterial and beta lactamase inhibitor, and durlobactam, a beta lactamase inhibitor. 

Xacduro is specifically indicated in patients 18 years of age and older for the treatment of hospital acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Xacduro is supplied as a solution for intravenous injection.

• The recommended dosage of Xacduro is 1 gram (g) of sulbactam and 1 g of durlobactam every 6 hours administered by intravenous (IV) infusion over 3 hours in adults with a creatinine clearance (CLcr) of 45 to 129 mL/min.
•  Adjustments to the dosing regimen for Xacduro are recommended for patients with CLcr less than 45 mL/min and for patients with CLcr greater than or equal to 130 mL/min.
•  The recommended duration of treatment with Xacduro is 7 to 14 days. The duration of therapy should be guided by the patient’s clinical status.

Mechanism of Action

Sulbactam is a beta-lactam antibacterial and Ambler Class A serine beta-lactamase inhibitor that has bactericidal activity due to its inhibition of Acinetobacter baumannii-calcoaceticus complex (ABC) penicillin-binding proteins PBP1 and PBP3, which are essential enzymes required for bacterial cell wall synthesis.

Durlobactam is a diazabicyclooctane non-beta-lactam, beta-lactamase inhibitor, that protects sulbactam from degradation by certain serine-beta-lactamases. Durlobactam alone does not have antibacterial activity against ABC isolates.

Side Effects

Adverse effects associated with the use of Xacduro may include, but are not limited to, the following:

• liver test abnormalities
• diarrhea
• anemia
• hypokalemia

Clinical Trial Results

The FDA approval was based on an array of scientific evidence, including results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of Xacduro versus colistin in patients with infections caused by Acinetobacter. In the trial, Xacduro demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.