DURLOBACTAM (XACDURO) (durlobactam sodium)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min

There are 0 moderate contraindications.

There are 8 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Anemia Hypokalemia	Cardiac arrhythmia Kidney disease with reduction in glomerular filtration rate (GFr) Thrombocytopenic disorder

Rare/Very Rare
Clostridioides difficile infection Hypersensitivity drug reaction

There are 2 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea	Constipation

Rare/Very Rare
None.

There are no available data on sulbactam/durlobactam use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are case reports and case series describing sulbactam use (in combination with ampicillin) in pregnancy; no drug-associated risk or adverse maternal or fetal outcomes have been reported. Studies show that sulbactam does cross the placenta.

In animal studies, doses up to 10 times the human dose have not demonstrated evidence of harm to the fetus. There are no available data on durlobactam use in pregnant women. In animal studies, no drug-induced fetal malformations were observed, but an increased incidence of fetal skeletal variations was observed when durlobactam was administered during organogenesis at 2- and 4- times the Maximum Recommended Human Dose.

Sulbactam is present in human milk in low concentrations; a maximum daily infant dose of 560 mcg/kg/day, assuming mean milk consumption of 200 mL/kg/day, has been reported. It is not known whether durlobactam is distributed into human milk. Effects of sulbactam, durlobactam, or the combination of sulbactam/durlobactam on breast-fed infants or milk production are not known.

In the ATTACK trial, 54% of sulbactam/durlobactam-treated patients were >=65 years of age, and 19% of patients were >=76 years of age. There were not enough patients >=65 years of age to determine whether they respond differently than younger patients; however, sulbactam/durlobactam is renally excreted, and because geriatric patients are more likely to have decreased renal function, changes in renal function should be closely monitored.