Sulbactam and durlobactam
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Dosing in kidney impairment
Dosage in Patients (18 Years of Age and Older) Based on Renal Function See Table 1 for the recommended dosage of XACDURO in patients (18 years of age and older) based on renal function [see Use in Specific Populations and Clinical Pharmacology ] . Adjustments to the dosing regimen are recommended for patients with creatinine clearance (CLcr) less than 45 mL/min and patients with augmented renal clearance (CLcr greater than or equal to 130 mL/min).
For patients undergoing intermittent hemodialysis (HD), start the dosing of XACDURO immediately after the completion of HD. For patients with fluctuating renal function, monitor CLcr and adjust dosage accordingly [see Use in Specific Populations ] . [See table below.]
| Dose of Sulbactam and Durlobactam (g) | Estimated CLcr (mL/min)CLcr = creatinine clearance estimated by Cockcroft-Gault equation | Frequency |
|---|---|---|
| sulbactam 1 g and durlobactam 1 g | Greater than or equal to 130 | Every 4 hours |
| 45 to 129 | Every 6 hours | |
| 30 to 44 | Every 8 hours | |
| 15 to 29 | Every 12 hours | |
| less than 15For patients on hemodialysis, the dose should be administered after the dialysis session has ended | 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 |
Dosing in liver impairment
Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of sulbactam and durlobactam have not been evaluated. Hepatic impairment is not expected to alter the elimination of XACDURO as neither sulbactam nor durlobactam undergo substantial hepatic metabolism/excretion. Dosage adjustments are not necessary in patients with impaired hepatic function.
Preparation and administration
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Administration The prepared XACDURO solution [see Dosage and Administration ] 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.
Preparation of XACDURO for Intravenous Administration XACDURO is a co-packaged kit containing 1 clear single-dose vial of sulbactam 1g and 2 amber single-dose vials of durlobactam 0.5g as sterile powders that must be reconstituted and further diluted using aseptic technique prior to intravenous infusion. 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. Items required to prepare XACDURO: XACDURO kit (includes one sulbactam 1 g single-dose vial and two durlobactam 0.5 g single-dose vials) 100 mL infusion bag containing 0.9% Sodium Chloride Injection, USP 10 mL Sterile Water for Injection, USP 10 mL sterile syringe and alcohol wipes Preparation of XACDURO: 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. The reconstituted solution is not for direct injection and must be diluted before intravenous infusion. Dilution must occur within 1 hour of reconstitution. Reconstitute each durlobactam 0.5 g single-dose vial 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. The reconstituted solution is not for direct injection and must be diluted before intravenous infusion. Dilution must occur within 1 hour of reconstitution. To prepare the required XACDURO 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.
Compatibility XACDURO is compatible with 0.9% Sodium Chloride Injection, USP. The compatibility of XACDURO for administration with solutions containing other drugs or other diluents has not been established. XACDURO should not be mixed with other drugs or physically added to solutions containing other drugs.
Storage of Prepared Solution in Infusion Bag 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.
Drug interactions
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- Sulbactam and durlobactam
Label text (2 paragraphs)
Organic Anion Transporter 1 (OAT1) Inhibitors : Concomitant administration with OAT1 inhibitors may increase plasma concentrations of XACDURO. Concomitant administration is not recommended. ( 7.1 )
7.1 Organic Anion Transporter 1 (OAT1) Inhibitors Concomitant administration with OAT1 inhibitors may increase plasma concentrations of sulbactam. Concomitant administration of OAT1 inhibitors (e.g., probenecid) with XACDURO is not recommended. [see Clinical Pharmacology (12.3) ] .
Contraindications
4 CONTRAINDICATIONS XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1) ] . Known history of severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sulbactam and durlobactam. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary XACDURO 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. Individual Components of XACDURO Sulbactam: Available published data from case reports and case series with sulbactam use in combination with ampicillin during pregnancy over many decades have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The published literature reports that sulbactam crosses the human placenta.
Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of harm to the fetus due to sulbactam (see Data ). Durlobactam: There are no available data on the use of durlobactam in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Durlobactam administered to pregnant mice and rats during organogenesis, showed no drug-induced fetal malformations but an increased incidence of skeletal variations was observed in mice at 2- and 4-times the Maximum Recommended Human Dose (MRHD) (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Sulbactam: Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of harm to the fetus due to sulbactam sodium/ampicillin sodium.
Durlobactam: Daily administration of durlobactam at 400, 800, or 1600 mg/kg/day (administered as four doses per day) via subcutaneous injection to pregnant mice from gestation day (GD) 6 through 15 resulted in durlobactam-related, increased incidence of skeletal variations (unossified calcaneum) of the hindlimb and asymmetrical ossification of the sternebrae and supernumerary ribs at 800 and/or 1600 mg/kg, equivalent to 2- and 4-times the maximum recommended human dose based on area under the curve (AUC) comparisons. No adverse effects on mean body weight, reproductive performance, or cesarean section parameters were observed in any pregnant mice.
IV infusion (2 hours/day) of durlobactam to pregnant female Sprague Dawley…
Breastfeeding (LactMed)
Sulbactam produces low levels in milk that are not expected to cause adverse effects in breastfed infants. It is likely that durlobactam produces similar levels in milk. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, have been reported with penicillins, but these effects have not been adequately evaluated. Sulbactam-durlobactam is acceptable in nursing mothers.
Supply and cost
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Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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