Treatment of Influenza
Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU for the treatment of influenza. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 2 below.
Table 2 Recommended Dose Adjustments for Treatment of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis
| Renal Impairment/Creatinine Clearance |
Recommended Treatment Regimen* |
Mild
Creatinine Clearance >60-90 mL/min |
75 mg twice daily for 5 days |
Moderate
Creatinine Clearance >30-60 mL/min |
30 mg twice daily for 5 days |
Severe
Creatinine Clearance >10-30 mL/min |
30 mg once daily for 5 days |
ESRD Patients on Hemodialysis
Creatinine Clearance ≤10 mL/min |
30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days† |
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
Creatinine Clearance ≤10 mL/min |
A single 30 mg dose administered immediately after a dialysis exchange |
| *Capsules or suspension can be used for 30 mg dosing.
†Assuming three hemodialysis sessions are performed in the 5-day period. Treatment can be initiated immediately if influenza symptoms develop during the 48 hours between hemodialysis sessions; however, the post-hemodialysis dose should still be administered independently of time of administration of the initial dose.
‡Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients. |
Prophylaxis of Influenza
For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU [see Clinical Pharmacology (12.3)]. The duration of prophylaxis is the same as recommended for patients with normal renal function. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 3 below.
Table 3 Recommended Dose Adjustments for Prophylaxis of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis
| Renal Impairment/Creatinine Clearance |
Recommended Prophylaxis Regimen* |
Mild
Creatinine Clearance >60-90 mL/min |
75 mg once daily |
Moderate
Creatinine Clearance >30-60 mL/min |
30 mg once daily |
Severe
Creatinine Clearance >10-30 mL/min |
30 mg every other day |
ESRD Patients on Hemodialysis
Creatinine Clearance ≤10 mL/min |
30 mg after alternate hemodialysis cycles† |
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
Creatinine Clearance ≤10 mL/min |
30 mg once weekly immediately after dialysis exchange |
*Capsules or suspension can be used for 30 mg dosing.
†An initial dose can be administered prior to the start of dialysis.
‡Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients. |
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