Xacduro

Generic name: sulbactam/durlobactam
Dosage form: Injection for intravenous infusion
Drug class: Penicillins / beta-lactamase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on May 24, 2023.

What is Xacduro?

Xacduro is a combination antibiotic injection containing sulbactam and durlobactam that may be used in adults to treat hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex.

Acinetobacter infections typically occur in healthcare settings, such as hospitals, with those on ventilators, with catheters, in ICU, with open surgical wounds, or with prolonged stays more at risk. Acinetobacter can spread through direct contact with contaminated surfaces or equipment or from person to person. They are responsible for over 8,500 infections a year in the U.S. and over 700 deaths and the World Health Organization has declared Acinetobacter species top of the list of critical bacterial pathogens that pose the greatest threat to human health. Most Acinetobacter infections are caused by one of four species from the Acinetobacter baumannii-calcoaceticus complex and are typically resistant to antibiotics, including carbapenem, making them difficult to treat.

Xacduro was approved on May 23, 2023.

Warnings

Xacduro should not be used in patients with a known hypersensitivity to sulbactam, other beta-lactam antibiotics, durlobactam, or any other components of the injection. If an allergic reaction occurs, discontinue Xacduro.

Xacduro may be associated with an increased risk of Clostridiodes difficile-associated diarrhea.

Should not be used to treat infections caused by pathogens other than Acinetobacter species.

Children

The safety and effectiveness of Xacduro in pediatric patients younger than 18 years of age has not been established.

Pregnancy

There are no specific data on the use of Xacduro during pregnancy.

Lactation

There are no data on the presence of durlobactam in human or animal milk. Sulbactam is present in human milk in low concentrations. There are no data on the effects of Xacduro, sulbactam, or durlobactam on the breastfed infant or on milk production.

How is Xacduro administered?

Xacduro is administered by intravenous infusion over three hours in people with CL_CR of 45 mL/min to 129 mL/min. It is usually given every 6 hours. The prepared solution should be used immediately or stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and used within 24 hours. Discard any unused portion not used within 24 hours.

A dosage reduction is needed in people with CL_CR <45 mL/min, and an adjustment is needed for CL_CR >130 mL/min.

What are the side effects of Xacduro?

The most common side effects of Xacduro from clinical trials were liver function test abnormalities, diarrhea, anemia, and hypokalemia (low potassium).

Related/similar drugs

What other drugs will affect Xacduro?

Plasma concentrations of Xacduro may be increased if given together with organic anion transporter 1 (OAT1) inhibitors, such as:

• cimetidine
• diclofenac
• probenecid.

Concomitant administration is not recommended. See the prescribing information for a complete list of drug interactions.

Ingredients

Xacduro contains sulbactam, an antibiotic structurally related to penicillin that kills A. baumannii and durlobactam, a beta-lactamase inhibitor that prevents sulbactam from being degraded by beta-lactamase enzymes that may be produced by A. baumannii.

It is presented as a co-packaged kit that contains the following for reconstitution:

• 1 clear single-dose vial of sulbactam 1 gram
• 2 amber single-dose vials of durlobactam 0.5 gram.

Manufacturer

Entasis Therapeutics Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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