BAVENCIO® (avelumab) Dosing Information

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BAVENCIO® (avelumab) dosing and administration

800 mg
IV INFUSION
GIVEN OVER
60 MINUTES
EVERY
2 WEEKS

  • BAVENCIO is 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

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

Preparation

  • Visually inspect vial for particulate matter and discoloration. BAVENCIO is a clear, colorless to slightly yellow solution. Discard vial if the solution is cloudy, discolored, or contains particulate matter
  • Withdraw the required volume of BAVENCIO from the vial(s) and inject it into a 250 mL infusion bag containing either 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection
  • Gently invert the bag to mix the diluted solution; avoid foaming or excessive shearing
  • Inspect the solution to ensure it is clear, colorless, and free of visible particles
  • Discard any partially used or empty vials

Storage of diluted solution

  • Protect from light
  • Store diluted BAVENCIO solution at room temperature up to 77°F (25°C) for no more than 4 hours from the time of dilution, or
  • Under refrigeration at 36°F to 46°F (2°C to 8°C) for no more than 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration
  • Do not freeze or shake the diluted solution

Administration

  • Administer the diluted solution over 60 minutes through an intravenous line containing a sterile, nonpyrogenic, low protein binding in-line filter (pore size of 0.2 micron)
  • Do not coadminister other drugs through the same intravenous line

Pharmacodynamics

  • Based on exposure efficacy and exposure safety relationships, there are no expected clinically meaningful differences in the safety or efficacy of BAVENCIO administered every 2 weeks at 800 mg or 10 mg/kg

Pharmacokinetics

  • Based on a population pharmacokinetic analysis, there are no expected clinically meaningful differences in exposure of BAVENCIO administered every 2 weeks at 800 mg or 10 mg/kg in both settings
  • The pharmacokinetics of avelumab as a single agent was studied in 1629 patients who received doses ranging from 1 to 20 mg/kg every 2 weeks
  • The data showed that the exposure of avelumab increased dose-proportionally in the dose range of 10 to 20 mg/kg every 2 weeks
  • Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing, and the systemic accumulation was approximately 1.25-fold
  • The geometric mean volume of distribution at steady state for a subject receiving 10 mg/kg was 4.72 L
  • The primary elimination mechanism of avelumab is proteolytic degradation
  • Based on population pharmacokinetic analyses in patients with solid tumors, the total systemic clearance was 0.59 L/day and the terminal half-life was 6.1 days in patients receiving 10 mg/kg
  • In a post hoc analysis, avelumab clearance was found to decrease over time in patients with MCC, with a mean maximal reduction (% coefficient of variation [CV%]) from baseline value of approximately 32.1% (36.2%), which is not considered clinically important
  • There was no evidence to suggest a change of avelumab clearance over time in patients with UC

Renal impairment  

  • No clinically meaningful differences in pharmacokinetics were observed in the clearance of BAVENCIO based on mild, moderate, or severe renal impairment

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 is unknown

ULN, upper limit of normal.