Safety
Well-tolerated and a favorable safety profile
Significantly reduced nephrotoxicity vs. colistin1
Incidence of nephrotoxicity as measured by the RIFLE criteria* at any post baseline visit1
RIFLE (risk, injury, failure, loss, or end-stage renal disease) measured by creatinine level or glomerular filtration rate, but not urinary output. Nephrotoxicity defined as meeting any of the RIFLE criteria at any post-baseline visit; if patients had multiple RIFLE events, the patient was counted only once at the highest severity. No patients in this study experienced end-stage renal disease.
For patients with creatinine clearance <45 mL/min or ≥130 mL/min, please see Full Prescribing Information.
Selected adverse reactions occurring at a frequency of >5%
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| Adverse Reaction | XACDURO (N=91) n (%) | Colistin (N=86) n(%) |
|---|---|---|
| Any adverse reaction | 80 (88) | 81 (94) |
| Liver test abnormalities† | 17 (19) | 18 (21) |
| Diarrhea | 15 (17) | 9 (11) |
| Anemia | 12 (13) | 12 (14) |
| Hypokalemia | 11 (12) | 9 (11) |
| Arrhythmia | 8 (9) | 8 (9) |
| Acute kidney injury† | 5 (6) | 31 (36) |
| Thrombocytopenia | 5 (6) | 3 (4) |
| Constipation | 5 (6) | 5 (6) |
Liver test abnormalities includes the following adverse reactions: liver function test abnormal, hepatic function abnormal, increased transaminases, ALT increased, and AST increased; Acute kidney injury includes the following adverse reactions: renal impairment, blood Cr increased, toxic nephropathy, renal failure and acute kidney injury.
Adverse reactions leading to discontinuation of treatment occurred in 11% of XACDURO patients vs. 16% of colistin patients. One patient treated with XACDURO developed anaphylactic shock which led to discontinuation of treatment.
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References:
1. Kaye KS, Shorr AF, Wunderink RG, et al. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatmentof 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, 2023. doi:10.1016/S1473‑3099(23)00184‑6.