From the FDA Drug Label
A single dose study compared 6 subjects with severe renal impairment (creatinine clearance < 30 mL/min), 4 end stage renal disease (ESRD) patients receiving tigecycline 2 hours before hemodialysis, 4 ESRD patients receiving tigecycline 1 hour after hemodialysis, and 6 healthy control subjects The pharmacokinetic profile of tigecycline was not significantly altered in any of the renally impaired patient groups, nor was tigecycline removed by hemodialysis. No dosage adjustment of tigecycline is necessary in patients with renal impairment or in patients undergoing hemodialysis
The recommended dosage of tigecycline for patients with Chronic Kidney Disease (CKD) and impaired renal function is the same as for patients with normal renal function.
- No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis 1.
From the Research
Tigecycline dosing does not require adjustment for patients with chronic kidney disease (CKD) or impaired renal function. The standard recommended dosage for tigecycline is an initial loading dose of 100 mg intravenously, followed by 50 mg intravenously every 12 hours for most infections. This dosing regimen remains the same regardless of renal function status, including for patients on hemodialysis or with severe renal impairment, as supported by a study published in the Journal of Clinical Pharmacology 2.
Key Points to Consider
- Tigecycline is primarily eliminated through biliary excretion, with minimal renal clearance, which explains why dose adjustments are not necessary in renal impairment.
- However, dose adjustments may be needed for patients with severe hepatic impairment (Child-Pugh C), where the maintenance dose should be reduced to 25 mg every 12 hours after the standard 100 mg loading dose, as suggested by a study published in Antibiotics (Basel, Switzerland) 3.
- Clinicians should monitor patients for common adverse effects including nausea, vomiting, and diarrhea, which may be more pronounced in patients with multiple comorbidities.
- The management of CKD involves a comprehensive approach, including cardiovascular risk reduction, treatment of albuminuria, and avoidance of potential nephrotoxins, as outlined in a review published in JAMA 4.
Clinical Implications
- The pharmacokinetic profile of tigecycline supports its use in patients with CKD without the need for dose adjustment, making it a valuable option for treating infections in this population.
- Clinicians should be aware of the potential for adverse effects and monitor patients accordingly, especially in those with multiple comorbidities.
- The importance of considering liver function in dosing tigecycline is highlighted by studies such as 3, which guides dose adjustments in patients with severe hepatic impairment.