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. Tigecycline is primarily eliminated through biliary excretion, with approximately 33% of the drug excreted unchanged in bile and only about 22% eliminated via the kidneys. This pharmacokinetic profile explains why dose adjustments are not necessary in renal impairment.
Some key points to consider when administering tigecycline to patients with CKD include:
- Monitoring for adverse effects, including nausea, vomiting, and potential increased mortality risk associated with tigecycline use compared to other antibiotics
- Being aware of the patient's overall health status and adjusting treatment as necessary to minimize complications
- Considering the potential impact of CKD on the patient's ability to tolerate certain medications and adjusting treatment accordingly
It's also important to note that while tigecycline dosing does not require adjustment for patients with CKD, other aspects of patient care may need to be adjusted, such as monitoring for complications of CKD and managing cardiovascular risk, as discussed in a review published in JAMA 3 and a study published in the Lancet 4. Additionally, patients with severe hepatic impairment (Child-Pugh C) may require dose adjustments, with a reduced maintenance dose of 25 mg every 12 hours after the standard 100 mg loading dose.