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The recommended dose is 160 mg Regorafenib (four 40 mg tablets) taken orally once daily for the first 21 days of each28-day cycle. Continue treatment until disease progression or unacceptable
toxicity.
Take Regorafenib at the same time each day. Swallow tablet whole with water after a low-fat meal that contains less than600 calories and less than 30% fat [see Clinical Pharmacology (12.3)]. Do not
take two doses of Regorafenib on the same day to make up for a missed dose from the previous day.
If dose modifications are required, reduce the dose in 40 mg (one tablet) increments; the lowest recommended daily doseof Regorafenib is 80 mg daily.
• Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia syndrome (PPES)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR
• Symptomatic Grade 2 hypertension
• Any Grade 3 or 4 adverse reaction
• Worsening infection of any grade
• For the first occurrence of Grade 2 HFSR of any duration
• After recovery of any Grade 3 or 4 adverse reaction except infection
• For Grade 3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT)
elevation, only resume if the potential benefit outweighs the risk of hepatotoxicity
• For re-occurrence of Grade 2 HFSR at the 120 mg dose
• After recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity or infection)
• Failure to tolerate 80 mg dose
• Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN)
• Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN
• Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg
• For any Grade 4 adverse reaction; only resume if the potential benefit outweighs the risks
from FDA，2020.02
