Why XACDURO

Fight back against Acinetobacter

Medical Need

Rates of Acinetobacter incidence are on the rise1

Globally, Acinetobacter baumannii is one of the six leading bacterial pathogens responsible for deaths attributable to antibiotic resistance2

Can be deadly, with an estimated 26.0% to 55.7% mortality rate3

Poses a critical threat to patients in nursing homes and hospitals, and to those who require ventilators and blood catheters4

Acinetobacter has become resistant to most antibiotics used to treat HABP/VABP, including carbapenems and third-generation cephalosporins4

The CDC classifies CRAB as an urgent public health threat.5

As of 2024, the CDC reported a significant increase in hospital‑onset carbapenem‑resistant Acinetobacter infections in 2022 compared to 2019.1

Outcomes are worse in patients with CRAB infections:*

  • 2x higher odds of mortality in adult hospital patients6
  • 2 days longer hospital stay on average7

In comparison to patients with carbapenem‑susceptible Acinetobacter baumannii.

Mechanism of Action

Attack & restore: The dual action antibiotic treatment

XACDURO is the only treatment with durlobactam and developed for classes A, C, and D β‑lactamase inhibition to target Acinetobacter8,9

Sulbactam attacks Acinetobacter8

  • Sulbactam: Bactericidal activity against Acinetobacter
    • β‑lactam penicillin derivative8,10
  • Mechanism of action: Inhibits penicillin‑binding proteins 1 and 3 → inhibits bacterial cell wall synthesis8,9,11

Durlobactam: Broad‑spectrum β‑lactamase inhibitor8

  • Non-β‑lactam diazabicyclooctane β‑lactamase inhibitor8,10
  • Mechanism of action: Protects sulbactam from hydrolysis → restores activity of sulbactam8-10

Slide table to view more

Spectrum of in vitro β‑lactamase
inhibitor activity9,12,13,a

 
Class A
Class C
Class D
Class B
β-lactamase
inhibitorb
 
 
 
No inhibitors with
broad activity
Clavulanic acid
Sulbactam
Tazobactam
±
±
±
-
Avibactam
Relebactam
Vaborbactam
+
+
±
-
Durlobactam
+
+
+
-

Clinical significance cannot be inferred from in vitro data.

Approved indications may not include carbapenem-resistant Acinetobacter baumannii.

+, active against β‑lactamases; -, not active against β‑lactamases, ±, active against select β‑lactamases.

In vitro activity against Acinetobacter

5,032 Acinetobacter baumannii-calcoaceticus complex global clinical isolates from 2016-202110

Slide table to view more

Antimicrobial
Agent
MIC90
(μg/mL)
MIC Range
(μg/mL)
%
Susceptible
XACDURO2≤0.03 to >6498.3
Sulbactam640.25 to >6446.9
Cefepime>16≤0.12 to >1644.6
Imipenem>64≤0.03 to >6448.9
Meropenem>64≤0.03 to >6447.9
Amikacin>64≤0.5 to >6458.6
Ciprofloxacin>4≤0.12 to >444.4
Colistin1≤0.25 to >8NA
Minocycline16≤0.12 to >1678.3

MIC interpretation as published by CLSI (CLSI M100 2021). For XACDURO, a susceptibility breakpoint of 4/4 μg/mL was used. Sulbactam MICs were interpreted using the sulbactam component of CLSI M100 (2021) ampicillin-sulbactam MIC breakpoints (≤8/4 [susceptible], 16/8 [intermediate], and ≥32/16 [resistant]) given that sulbactam is well established to comprise the active component of the combination for Acinetobacter spp.10,14

Patient Profiles

Identifying potential patients

Can XACDURO make a difference for your patients?

Not an actual patient.

Joyce, 79

Resides in skilled nursing facility

Condition:

Critically ill and hospitalized

Current Diagnosis:

HABP caused by Acinetobacter baumannii

Medical History:

Hypertension, ischemic heart disease, and atrial fibrillation

Antibiotic History:

NA

Not an actual patient.

Evan, 62

Resides in long-term care (LTC) facility

Condition:

Critically ill and hospitalized

Current Diagnosis:

Multidrug resistant A. baumannii necrotizing pneumonia (VABP) complicated with empyema

Medical History:

COPD, hypertension, renal insufficiency

Antibiotic History:

~90 days ago for community‑acquired bacterial pneumonia within LTC facility

A. baumannii, Acinetobacter baumannii; COPD=chronic obstructive pulmonary disease.

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Request to speak with a XACDURO sales representative or receive information.

Treat with Precision.

Choose pathogen-targeted coverage for HABP/VABP caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex with XACDURO.15

Order XACDURO

References:

1. Centers for Disease Control and Prevention (CDC). Antimicrobial resistance threats in the United States, 2021-2022. Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/antimicrobial-resistance-threats-update-2022-508.pdf. Accessed April 4, 2025 2. Antimicrobial Resistance Collaborators. Lancet. 2022;399(10325):629‑655. doi:10.1016/S0140‑6736(21)02724‑0 3. Appaneal HJ, et al. Antimicrob Agents Chemother. 2022;66(3):e0197521. doi:10.1128/AAC.01975‑21 4. World Health Organization. WHO publishes list of bacteria for which new antibiotics are urgently needed. Accessed June 28, 2023. https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed. Published February 27, 2017 5. Centers for Disease Control and Prevention (CDC). Carbapenem‑resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities. Available at: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat. Last accessed April 1, 2025. 6. Ling W, et al. JAC Antimicrob Resist. 2021;3(4):dlab157. doi:10.1093/jacamr/dlab157 7. Pogue JM, et al. BMC Infect Dis. 2022;22(1):36. doi:10.1186/s12879‑021‑07024‑4 8. XACDURO®. Package Insert. Innoviva Specialty Therapeutics, Inc.; 2023. 9. Papp-Wallace KM, McLeod SM, Miller AA. Clin Infect Dis. 2023;76(Suppl 2):S194‑S201. doi:10.1093/cid/ciad095 10. Karlowsky JA, et al. Antimicrob Agents Chemother. 2022;66(9):e007812. doi:10.1128/aac.00781‑22 11. Penwell WF et al. Antimicrob Agents Chemother. 2015;59(3):1680‑1689. doi:10.1128/AAC.04808‑14 12. Eiamphungporn W, et al. Int J Mol Sci. 2018;19(8):2222. doi:10.3390/ijms19082222 13. Vázquez‑Ucha JC, et al. Int J Mol Sci. 2020;21(23):9308. doi:10.3390/ijms21239308 14. Clinical and Laboratory Standards Institute. 2021. Performance standards for antimicrobial susceptibility testing. M100, 31st ed. CLSI, Wayne, PA. 15. Kaye KS, et al. Lancet Infect Dis. 2023;11:s1473‑3099(23)00184‑6. doi:10.1016/s1473‑3099(23)00184‑6

Indication & Usage

Indication & Usage

Indication

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults 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.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Before administering, please see the Full Prescribing Information for XACDURO.

Important Safety Information

Indication & Usage

Indication

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults 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.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Before administering, please see the Full Prescribing Information for XACDURO.

Important Safety Information

Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.

Warnings and Precautions:

  • Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed.
  • Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

Innoviva Specialty Therapeutics, Inc.™
1-800-651-3861
medinfo@istx.com
U.S. Food and Drug Administration
1-800-FDA-1088

Before administering, please see the Full Prescribing Information for XACDURO.

Indication & Usage

Indication

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults 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.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Before administering, please see the Full Prescribing Information for XACDURO.

Important Safety Information

Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.

Warnings and Precautions:

  • Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed.
  • Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

Innoviva Specialty Therapeutics, Inc.™
1-800-651-3861
medinfo@istx.com
U.S. Food and Drug Administration
1-800-FDA-1088

Before administering, please see the Full Prescribing Information for XACDURO.

  • Prescribing Information
  • Important Safety Information
  • Ordering Info
  • Medwatch

XACDURO® is marketed by Innoviva Specialty Therapeutics, Inc.

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