Pharmacokinetic Profile of Kineret anakinra

1
Pharmacokinetic Profile of Kineret (anakinra)

2
Pharmacokinetic Properties of Anakinra

• Bioavailability 95 at subcutaneous (SC) dose
  of 70 mg
• Peak plasma concentration 37 h following SC
  administration at 12 mg/kg
• Terminal half-life 46 h after SC
  administration at 12 mg/kg
• Kidney is the major organ for clearance
• Subjects with end-stage renal disease on dialysis
  had substantially lower plasma clearance (18
  mL/min) and longer terminal half-life (7 h)
• Subjects with hepatic dysfunction also had lower
  clearance, which correlated with a decrease in
  plasma creatinine clearance
• No unexpected accumulation of anakinra observed
  after daily SC doses for up to 24 weeks
• Creatinine clearance and body weight are
  predictors of plasma clearance of anakinra

Amgen Inc. Kineret? (anakinra) FDA Briefing
Information, August 16, 2001. Available at
http//www.fda.gov Kineret? (anakinra) summary
of product characteristics.
3
Anakinra Pharmacokinetic Profile After SC
Administration in RA Patients
Amgen Inc. Kineret? (anakinra) FDA arthritis
advisory board slides http//www.fda.gov/ohrms/do
ckets/ac/01/slides/3779s1_01_Amgen.PPT