Regorafenib (Specialist drug)

Do not take two doses on the same day to make up for a missed dose from the previous day. Dose modifications: reduce in 40 mg (one tablet) increments; the lowest recommended daily dose is 80 mg daily. Reduce to 120 mg for the first occurrence of Grade 2 hand-foot skin reaction (HFSR/palmar-plantar erythrodysaesthesia) of any duration, after recovery of any Grade 3 or 4 adverse reaction except infection, and for Grade 3 AST/ALT elevation (only resume if the potential benefit outweighs the risk of hepatotoxicity). Reduce to 80 mg for re-occurrence of Grade 2 HFSR at the 120 mg dose and after recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity or infection). Interrupt for recurrent Grade 2 HFSR not improving within 7 days despite dose reduction (minimum 7 days interruption for Grade 3 HFSR), symptomatic Grade 2 hypertension, any Grade 3 or 4 adverse reaction, or worsening infection of any grade. Permanently discontinue for failure to tolerate 80 mg, AST or ALT >20 x ULN, AST or ALT >3 x ULN with concurrent bilirubin >2 x ULN, re-occurrence of AST or ALT >5 x ULN despite reduction to 120 mg, or any Grade 4 adverse reaction (only resume if the potential benefit outweighs the risks). Withhold for at least 2 weeks prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing. Paediatric: safety and efficacy in patients less than 18 years of age have not been established. CLINICIAN CHECK: this draft is from the US FDA prescribing information (STIVARGA, Bayer HealthCare Pharmaceuticals, label date 2026-02-09) — no UK SPC posology was fetched; verify against the UK SPC.