Sulbactam/durlobactam

What is Sulbactam/durlobactam?

• Sulbactam/durlobactam (Xacduro) is an antibacterial co-packaged product containing sulbactam sodium, a penicillin derivative beta-lactam antibacterial and beta-lactamase inhibitor, and durlobactam sodium, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration.

Sulbactam Sodium:

• Sulbactam sodium is a beta-lactam antibacterial and a beta-lactamase inhibitor.

Durlobactam Sodium:

• Durlobactam is a beta-lactamase inhibitor antibacterial drug.

Sulbactam and durlobactam

What are the uses of this medicine?

• Sulbactam/durlobactam (Xacduro) is used 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.

Limitations of Use:

• Xacduro is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

How does this medicine work?

• Xacduro is an antibacterial drug.
• Xacduro is a co-packaged product containing sulbactam and durlobactam.

• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements.

Be sure to mention any of the following:

• Organic Anion Transporter 1 (OAT1) Inhibitors (e.g., probenecid)

Is this medicine FDA approved?

• Sulbactam/durlobactam was approved for medical use in the United States in May 2023.

How should this medicine be used?

Recommended dosage:

• 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.
• Dosing regimen adjustments are recommended for CLcr less than 45 mL/min and CLcr greater than or equal to 130 mL/min.

Administration:

• Administer all doses of Xacduro by IV infusion over 3 hours.
• The prepared Xacduro solution should be brought to ambient room temperature (over 15 to 30 min) prior to infusion to the patient.
• Administer all doses of Xacduro by intravenous (IV) infusion over 3 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a co-packaged kit containing the following two components as sterile powders for reconstitution:
• 1 clear single-dose vial of sulbactam for injection 1 g and
• 2 amber single-dose vials of durlobactam for injection 0.5 g.

This medicine is available in fallowing brand namesː

• Xacduro

What side effects can this medication cause?

The most common side effects of this medicine may include:

• Liver test abnormalities
• Diarrhea
• Anemia
• Hypokalemia
• Arrhythmia
• Acute kidney injury
• Thrombocytopenia
• Constipation

Less common, but serious side effects may include:

• Hypersensitivity Reactions
• Clostridioides difficile-Associated Diarrhea (CDAD)

What special precautions should I follow?

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Advise the patient, their families, or caregivers that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask them about any previous hypersensitivity reactions to Xacduro (sulbactam and durlobactam), other beta-lactams (including cephalosporins) or other allergens.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Xacduro, and may range in severity from mild diarrhea to fatal colitis. Advise the patient, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including Xacduro. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, tell them to contact their healthcare provider.
• Patients should be counseled that antibacterial drugs, including Xacduro, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). Patients should be told that the medication should be administered exactly as directed.
• There are no data on the presence of durlobactam in human or animal milk. Sulbactam is present in human milk in low concentrations.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Sulbactam and durlobactam are removed by hemodialysis.
• No clinical information is available on the use of hemodialysis to treat overdosage.

Can this medicine be used in pregnancy?

• There are no available data on the use of Xacduro in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• 1 g sulbactam (equivalent to 1.1 g sulbactam sodium) and two amber single-dose vials each contain 0.5 g durlobactam (equivalent to 0.54 g durlobactam sodium)

Inactive ingredients:

• sodium hydroxide and hydrochloric acid

Who manufactures and distributes this medicine?

Distributed by:

• La Jolla Pharmaceutical Company, Waltham, MA
• Xacduro is a registered trademark of Entasis Therapeutics Ltd.

What should I know about storage and disposal of this medication?

• Xacduro vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F); brief exposure to 8°C to 15°C (46°F to 59°F) permitted.
• Do not freeze.
• Store prepared Xacduro solution in the refrigerator.

• Dailymed label info on Sulbactam/durlobactam
• FDA Sulbactam/durlobactam

Sulbactam/durlobactam Resources
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