Recommendations for Dosing in Adult Patients with Renal Impairment

Dosing in Adult Patients with Renal Impairment

Dose adjustment of oseltamivir is recommended for 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 oseltamivir for the treatment or chemoprophylaxis of influenza. Oseltamivir is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 3; duration of treatment and chemoprophylaxis is the same as recommended for patients with normal renal function. The dose of intravenous peramivir should be reduced for patients with baseline creatinine clearance below 50 mL/min (see Table 3).

No dose adjustment is recommended for inhaled zanamivir for a 5-day course of treatment for patients with renal impairment. Pharmacokinetic analysis did not identify a clinically meaningful effect of renal function on the pharmacokinetics of baloxavir in patients with creatinine clearance 50 mL/min and above. The effects of severe renal impairment on the pharmacokinetics of baloxavir marboxil or its active metabolite, baloxavir, have not been evaluated.

Table 3. Recommended Oseltamivir and Peramivir Dose Adjustments for Treatment or Chemoprophylaxis of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis*

* From package inserts for oseltamivir and peramivir; see FDA Influenza (Flu) Antiviral Drugs and Related Informationexternal icon.

Abbreviations: N/A = not applicable
¹ Renal dosing of oseltamivir is not available in the package insertexternal icon for pediatric patients. However, these tables may be useful for children who qualify for adult doses based on weight >40 kg.

² Assuming 3 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.

³ An initial dose can be administered prior to the start of dialysis.

⁴ Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

⁵ Renal dosing from peramivir package insertexternal icon is available for pediatric patients: Creatinine clearance ≥50 mL/min: 12 mg/kg (up to maximum dose of 600 mg); Creatinine clearance 30 to 49 mL/min: 4 mg/kg; Creatinine clearance 10 to 29 mL/min: 2 mg/kg.