Why XACDURO

Fight back against Acinetobacter

Medical Need

Rates of Acinetobacter incidence are on the rise1

5th most common cause of deaths attributable to drug resistance across the globe2

Can be deadly, with a 26.0% to 55.7% mortality rate3

Poses a threat to patients on ventilators in hospitals and nursing homes4

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

Carbapenem-resistant Acinetobacter is classified as a critical priority pathogen by the World Health Organization4

The spread is alarming, with a 78% increase in carbapenem-resistant Acinetobacter baumannii (CRAB) cases in US hospitals in 2020.1

Outcomes are worse in patients with CRAB infections:*

  • 2 days longer hospital stay on average5
  • 17.2% higher rate of ICU utilization5
  • 2x higher chance of in‑hospital death6

In comparison to patients with carbapenem-susceptible Acinetobacter baumannii.

The CDC has identified carbapenem-resistant Acinetobacter baumannii as an
urgent threat, noting a significant increase in hospital-onset cases since 2019.1,7

Mechanism of Action

Attack & restore: The dual action antibiotic treatment

XACDURO combines sulbactam with novel durlobactam creating a powerful duo against infections caused by Acinetobacter

Sulbactam attacks Acinetobacter

  • Penicillin derivative with intrinsic activity against Acinetobacter
  • Clinical utilization may be limited because β‑lactam resistance is common8

Durlobactam restores sulbactam

  • Diazabicyclooctane β‑lactamase inhibitor
  • Potent inhibitor of class A, C, and D β‑lactamases
  • Restores sulbactam activity in vitro and in vivo

Activity against Acinetobacter in vitro

5,032 Acinetobacter baumannii-calcoaceticus complex global clinical isolates from 2016-20219

Slide table to view more

Antimicrobial
Agent		MIC90
(μg/mL)		MIC Range
(μg/mL)		%
Susceptible*
XACDURO2≤0.03/4 to >64/498.3
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.9

Patient Profiles

Identifying potential patients

Can XACDURO make a life‑saving 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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References:

1. CDC. COVID-19: U.S. Impact on Antimicrobial Resistance, Special Report 2022. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2022. 2. Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet. 2022;399(10325):629‑655. doi: 10.1016/S0140-6736(21)02724‑0 3. Appaneal HJ, Lopes VV, LaPlante KL, Caffrey AR. Treatment, Clinical Outcomes, and Predictors of Mortality among a National Cohort of Admitted Patients with Acinetobacter baumannii Infection. Antimicrobial Agents and Chemotherapy. 2022;66(3):1‑2. doi:10.1128/AAC.01975‑21. 4. WHO publishes list of bacteria for which new antibiotics are urgently needed. World Health Organization. Published February 27, 2017. Accessed June 19, 2023. https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed. 5. Pogue JM, Zhou Y, Kanakamedala H, Cai B. Burden of illness in carbapenem-resistant Acinetobacter baumannii infections in US hospitals between 2014 and 2019. BMC Infect Dis. 2022;22:36. doi: 10.1186/s12879‑021‑07024‑4 6. Lemos EV, de la Hoz FP, Einarson TR, et al. Carbapenem resistance and mortality in patients with Acinetobacter baumannii infection: systematic review and meta-analysis. Clin Microbiol Infect. 2014;20(5):416‑423. doi: 10.1111/1469‑0691.12363 7. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States 2019. Accessed August 26, 2024. https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf 8. Pandey N, Cascella M. Beta-lactam antibiotics. StatPearls. Updated June 4, 2023. Accessed September 17, 2024. https://www.ncbi.nlm.nih.gov/books/NBK545311/ 9. Karlowsky JA, Hackel MA, McLeod SM, Miller AA. In vitro activity of sulbactam-durlobactam against global isolates of Acinetobacter baumannii-calcoaceticus complex collected from 2016 to 2021. Antimicrob Agents Chemother. 2022;66(9):e00781‑22. doi:10.1128/aac.00781‑22.

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
www.fda.gov/medwatch

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
www.fda.gov/medwatch

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

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XACDURO® is marketed by Innoviva Specialty Therapeutics, Inc.

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