Xacduro

About Xacduro 

• Xacduro is a Penicillins which belongs to the family called Beta-lactamase inhibitors.  
• Xacduro is a combination drug consisting of sulbactam, a beta-lactam antibiotic and beta-lactamase inhibitor, and durlobactam, a beta-lactamase inhibitor. 
• It is approved for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 and above, caused by susceptible strains of the Acinetobacter baumannii-calcoaceticus complex.
• Acinetobacter infections are often linked to healthcare settings, particularly hospitals. Patients on ventilators, with catheters, in ICUs, open surgical wounds, or extended hospital stays face a higher risk. Transmission can happen via contaminated surfaces, equipment, or person-to-person contact.

Strength: 

Injection: A single-dose vial contains 1g of sulbactam for injection, and there are two single-dose vials, each containing 0.5g of durlobactam for injection.

Recommended Dosage:

The drug is administered by a health care professional directly into the bloodstream through intravenous. Before administering Xacduro injection to the patient, the prepared solution should be allowed to reach ambient room temperature, which typically takes over 15 to 30 minutes. All doses of Xacduro should be administered to the patient via intravenous (IV) infusion, with each infusion lasting 3 hours.

• Xacduro should be administered to patients with a creatinine clearance (CLcr) between 45 and 129 mL/min as follows: 1 g of sulbactam and 1 g of durlobactam every 6 hours via intravenous (IV) infusion, with each infusion lasting 3 hours.
• For patients with CLcr values less than 45 mL/min or greater than or equal to 130 mL/min, adjustments to the dosing regimen are recommended.
• It’s important to note that all doses of Xacduro should be administered via IV infusion lasting 3 hours. For detailed instructions on preparing the intravenous solution, please refer to the full prescribing information.

Important:

Xacduro vial is devoid of a bacteriostatic preservative, and the prepared solution should be utilized within 24 hours when stored in a refrigerated environment at temperatures of 2°C to 8°C (36°F to 46°F). Any remaining unused portion should be discarded. Before administration, visually inspect parenteral drug products for particulate matter and discoloration, whenever the solution and container allow for it. 

The prepared Xacduro solution should have a clear, light yellow to orange appearance, with no visible particulates. Do not administer the Xacduro solution if it appears cloudy or contains any particulates. 

Warnings & Precautions

• Xacduro is contraindicated in patients with a history of known severe hypersensitivity to the components of Xacduro (sulbactam and durlobactam), or other beta-lactam antibacterial drugs.
• The use of Xacduro, like many antibacterial agents, has been associated with CDAD, which can range from mild diarrhea to severe colitis. 
• Prescribing Xacduro in the absence of a confirmed or strongly suspected bacterial infection or for prophylactic purposes is not likely to benefit the patient and may increase the risk of drug-resistant bacteria development.
• The safety and effectiveness of Xacduro in pregnant women have not been established. Xacduro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known whether Xacduro is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xacduro and any potential adverse effects on the breastfed child from Xacduro or from the underlying maternal condition.
• Dosage adjustment is not needed in patients with CLcr 45 to 129 mL/min. Whereas, Adjustments to the Xacduro dosing regimen are required in patients with CLcr less than 45 mL/min.
• The impact of liver impairment has not been assessed. However, there is no need for dosage adjustments in patients with impaired hepatic function.

Common Xacduro  Side Effects:

• Diarrhea
• Nausea
• Vomiting
• Constipation
• Headache
• Fatigue
• Low blood pressure
• Infusion reactions
• High blood sugar levels
• Low potassium levels
• Low sodium levels
• Liver problems
• Kidney problems
• Allergic reactions

Use in Specific Population

• Xacduro has not been proven to be safe and effective in pediatric patients under 18 years old.
• Clinical trials did not involve enough individuals aged 65 and over to determine if they have different responses compared to younger patients.
• In a study involving 91 patients treated with Xacduro, 54% were 65 years or older, including 19% who were 76 years or older. 

Storage and Handling

• Store Xacduro vial refrigerated at 2°C – 8°C (36°F – 46°F) in the original carton.
• Protect  the medicine from light. Do not freeze. Do not shake.
• Xacduro is a sterile product, and it should not be used if the vial is damaged or the seal is broken. 
• Always follow aseptic techniques, and any unused portions should be discarded. To ensure safety and effectiveness, never attempt to reuse the vial or infusion set.