BAVENCIO® (avelumab) Dosing Information

You are about to leave this site and are being redirected to another site. Would you like to leave this site?

BAVENCIO® (avelumab) dosing

Bavencio Dosing and Treatment Management Guide

Dosing resources

Image-1

Dosing and administration

  • The recommended dose of BAVENCIO is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity
  • Management of some adverse reactions may require temporary interruption or permanent discontinuation
Image-1

Premedication

  • Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO
  • Premedication should be administered for subsequent BAVENCIO doses based upon clinical judgment and presence/severity of prior infusion reactions
Image-1

Pharmacokinetics

  • The pharmacokinetics of BAVENCIO was studied in 1629 patients who received doses of 1 to 20 mg/kg once every 2 weeks
  • Exposure of BAVENCIO increased dose proportionally in the dose range of 10 to 20 mg/kg once every 2 weeks
  • The terminal half-life was 6.1 days in patients receiving 10 mg/kg
  • The steady-state concentrations of BAVENCIO were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing
Image-1

Renal impairment

  • No clinically meaningful differences in pharmacokinetics were observed in the clearance of BAVENCIO based on renal impairment
Image-1

Hepatic impairment

  • No clinically meaningful differences in pharmacokinetics were observed in the clearance of BAVENCIO based on mild or moderate hepatic impairment
  • There are limited data from patients with severe hepatic impairment (defined as bilirubin > 3 times ULN, n=1) and the effect of severe hepatic impairment on the pharmacokinetics of BAVENCIO are unknown
ULN, upper limit of normal.