You are Acinetobacter's WorstNightmare

when you use XACDURO against hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in adults caused by Acinetobacter.

It's the first and only treatment targeting HABP/VABP caused by susceptible isolates, which can include multidrug-resistant strains of Acinetobacter baumannii‑calcoaceticus complex.1,2

Explore XACDURO
Why XACDURO

Acinetobacter is a growing global threat3,4

Learn more
Efficacy

Powerful results against HABP/VABP infections caused by Acinetobacter

In the Phase 3 ATTACK noninferiority trial evaluating safety and efficacy of XACDURO vs. colistin for patients with serious infections due to ABC, including CRABC strains, XACDURO demonstrated:

  • Improved all-cause mortality rate
  • Significantly greater clinical cure rate
See the trial data

ABC=Acinetobacter baumannii-calcoaceticus complex;
CRABC=carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex.

Safety

Well‑tolerated and a favorable safety profile2

Learn more about safety

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References:

1. Data on File. Innoviva Specialty Therapeutics; 2023. 2. Kaye KS, Shorr AF, Wunderink RG, et al. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. 2023;23(9):1072‑1084 doi:10.1016/S1473‑3099(23)00184‑6 3. 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 4. CDC. COVID‑19: U.S. Impact on Antimicrobial Resistance, Special Report 2022. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2022.

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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