The information provided in this section is intended expressly for healthcare professionals in the United States. Click “OK” to enter if you are a US healthcare professional.
In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients in the STIVARGA® (regorafenib) arm and in 25.5% of patients in the placebo arm, including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome, and severe rash requiring dose modification
In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53%) than in the placebo-treated patients (8%)
Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment
The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson Syndrome (<0.1% vs 0%) were also higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3: 18%)
Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent
Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity
Monitor patients and intervene early
Conduct a full-body examination of the skin, with emphasis on the palms of the hands and soles of the feet2,3
HFSR typically occurs early in therapy. Maintain frequent contact with patients to ensure early diagnosis and intervention2
Other skin conditions, including severe rash, occur at a higher incidence in STIVARGA-treated patients1
Management of skin toxicities may include temporary treatment interruption and/or dose modification, or, in severe or persistent cases, permanent discontinuation. Institute supportive measures for symptomatic relief1