Dose modifications may help keep therapy manageable1

Dose modifications1

 
  Interrupt STIVARGA® (regorafenib) for the following Reduce STIVARGA dose to 120 mg Reduce STIVARGA dose to 80 mg Discontinue STIVARGA dose permanently for
the following
Hand-foot skin reaction (HFSR)
  • Grade 2 HFSR that is recurrent or does not improve within 7 days despite dose reduction
  • Grade 3 HFSR (interrupt for a minimum of 7 days)
  • First occurrence of Grade 2 HFSR of any duration
  • After recovery of Grade 3 HFSR
  • Re-occurence of Grade 2 HFSR at the 120-mg dose
  • After recovery from Grade 3 HFSR at 120-mg dose
  • Failure to tolerate the 80-mg dose
Liver function test abnormalities
  • Grade 3 aspartate aminotransferase (AST) / alanine aminotransferase (ALT) elevation
  • Grade 3 AST/ALT elevation–only resume
    outweighs the risk of hepatotoxicity
 
  • Any occurrence of AST/ALT >20x upper limit of normal (ULN)
  • Any occurrence of AST/ALT >3x ULN with concurrent bilirubin >2x ULN
  • Re-occurence of AST/ALT >5x ULN despite dose reduction to 120 mg
All other adverse reactions
  • Symptomatic Grade 2 hypertension
  • Any Grade 3 or 4 adverse event (AE)
  • Worsening infection of any grade
  • After recovery from any Grade 3 or 4 adverse reaction except infection
  • After recovery of any Grade 3 or 4 AE at the 120-mg dose (except hepatotoxicity or infection)
  • Failure to tolerate the 80-mg dose
  • Any Grade 4 AE (only resume if the potential benefit outweighs the risks)
 
  Interrupt STIVARGA® (regorafenib) for the following
Hand-foot skin reaction (HFSR)
  • Grade 2 HFSR that is recurrent or does not improve within 7 days despite dose reduction
  • Grade 3 HFSR (interrupt for a minimum of 7 days)
Liver- function test abnormalities
  • Grade 3 aspartate aminotransferase (AST) / alanine aminotransferase (ALT) elevation
All other adverse reactions
  • Symptomatic Grade 2 hypertension
  • Any Grade 3 or 4 AE
  • Worsening infection of any grade
 
  Reduce STIVARGA dose to 120 mg
Hand-foot skin reaction (HFSR)
  • First occurrence of Grade 2 HFSR of any duration
  • After recovery of Grade 3 HFSR
Liver- function test abnormalities
  • Grade 3 AST/ALT elevation–only resume if the potential benefit outweighs the risk of hepatotoxicity
All other adverse reactions
  • After recovery from any Grade 3 or 4 AE except infection
 
  Reduce STIVARGA dose to 80 mg
Hand-foot skin reaction (HFSR)
  • Re-occurence  of Grade 2 HFSR at the 120-mg dose
  • After recovery of Grade 3 HFSR at 120-mg dose
Liver function test abnormalities  
All other adverse reactions
  • After recovery from any Grade 3 or 4 AE at the 120-mg dose (except hepatotoxicity or infection)
 
  Discontinue STIVARGA dose permanently for
the following
Hand-foot skin reaction (HFSR)
  • Failure to tolerate the 80-mg dose
Liver- function test abnormalities
  • Any occurrence of AST/ALT >20x upper limit of normal (ULN)
  • Any occurrence of AST/ALT >3x ULN with concurrent bilirubin >2x ULN
  • Re-occurence of AST/ALT >5x ULN despite dose reduction to 120 mg
All other adverse reactions
  • Failure to tolerate the 80-mg dose
  • Any Grade 4 AE (only resume if the potential benefit outweighs the risks)
  • If dose modifications are required, reduce the dose in 40-mg (1 tablet) increments
  • The lowest recommended daily dose is 80 mg
  • Resume STIVARGA at the same dose following resolution of infection