Using XACDURO

Dosing and administration

Dosing

Quick reference

Dosing for patients 18 years of age and older

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XACDURO DosingEstimated CLcr*
(mL/min)
Frequency
sulbactam 1 g and durlobactam 1 gGreater than or
equal to 130
Every 4 hours
45 to 129Every 6 hours
30 to 44Every 8 hours
15 to 29Every 12 hours
less than 15

For patients initiating XACDURO: Every 12 hours for the first 3 doses (0, 12, and 24 hours), followed by every 24 hours after the third dose

For patients currently receiving XACDURO whose CLcr declines to less than 15 mL/min: Every 24 hours

Administer all doses of XACDURO by intravenous infusion over 3 hours.
The recommended duration of treatment with XACDURO is 7 to 14 days.
The duration of therapy should be guided by the patient's clinical status.

CLcr=creatinine clearance estimated by Cockcroft-Gault equation.

For patients on hemodialysis, the dose should be administered after the dialysis session has ended.

save more lives with XACDURO
For complete Dosing Information,
please see Full Prescribing Information
Preparation

Preparation steps

1

Reconstitute the sulbactam 1 g single-dose vial with 5 mL of Sterile Water for Injection and gently shake to dissolve. Each reconstituted vial contains 1 g of sulbactam per 5 mL of clear, colorless to slightly yellow solution.*

2

Reconstitute each of the 2 durlobactam 0.5 g single-dose vials with 2.5 mL of Sterile Water for Injection and gently shake to dissolve. Each reconstituted vial contains 0.5 g of durlobactam per 2.5 mL of clear, light yellow to orange solution.*

3

To prepare the required dose, withdraw 5 mL of reconstituted sulbactam and 5 mL (2.5 mL from each vial) of reconstituted durlobactam. Add the withdrawn volume of both sulbactam and durlobactam to a 100 mL infusion bag of 0.9% Sodium Chloride for Injection, USP. Discard unused portion.

The reconstituted solution is not for direct injection and must be diluted before intravenous infusion. Dilution must occur within 1 hour of reconstitution

Inspect visually for particulate matter and discoloration prior to administration.

The prepared XACDURO solution should appear as a clear, light yellow to orange solution, free of particulates. If the XACDURO solution is cloudy or contains particulates, do not administer.

Administration and Storage

How to administer and store

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 infusion over 3 hours.
XACDURO is a co-packaged kit containing 1 clear single-dose vial of sulbactam 1 g and 2 amber single-dose vials of durlobactam 0.5 g as sterile powders that must be reconstituted and further diluted using aseptic technique prior to intravenous infusion. Durlobactam must be administered with sulbactam.
XACDURO does not contain a bacteriostatic preservative and the prepared solution must be used within 24 hours when stored refrigerated at 2°C to 8°C (36°F to 46°F). Discard unused portion.
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 the prepared bag in the refrigerator at 2°C to 8°C(36°F to 46°F) until administration. The time between starting the reconstitution of the powders and the conclusion of the infusion should not exceed 24 hours. Do not freeze.
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use packagingXACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use packaging

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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
  • Medwatch

XACDURO® is marketed by Innoviva Specialty Therapeutics, Inc.

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