STIVARGA® (regorafenib) safety profile1

Adverse events (AEs) reported in ≥10% of patients and at a higher rate in the STIVARGA arm vs placebo in RESORCE*

STIVARGA safety profile

 STIVARGA (n=374)Placebo (n=193)
AEsAll grades
(%)
Grades ≥3
(%)
All grades
(%)
Grades ≥3
(%)
Skin and subcutaneous tissue disorders    
HFSR/Palmar-plantar erythrodysesthesia (HFSR/PPES)51127<1
General disorders and administration site conditions    
Pain559448
Asthenia/Fatigue4210335
Fever20070
Vascular disorders    
Hypertension311565
Hemorrhage185168
Gastrointestinal disorders    
Diarrhea413150
Nausea17<1130
Vomiting13<17<1
Mucositis1312≤1
Respiratory, thoracic, and mediastinal disorders    
Dysphonia18020
Infections and infestations    
Infection318186
Metabolism and nutrition
disorders
    
Decreased appetite and food intake313152
Investigations    
Weight loss13240
Musculoskeletal and
connective tissue disorders
    
Muscle spasms10020
 STIVARGA (n=374)
AEsAll grades
(%)
Grades ≥3
(%)
Skin and subcutaneous tissue disorders  
HFSR/Palmar-plantar erythrodysesthesia (HFSR/PPES)5112
General disorders and administration site conditions  
Pain559
Asthenia/Fatigue4210
Fever200
Vascular disorders  
Hypertension3115
Hemorrhage185
Gastrointestinal disorders  
Diarrhea413
Nausea17<1
Vomiting13<1
Mucositis131
Respiratory, thoracic, and mediastinal disorders  
Dysphonia180
Infections and infestations  
Infection318
Metabolism and nutrition
disorders
  
Decreased appetite and food intake313
Investigations  
Weight loss132
Musculoskeletal and
connective tissue disorders
  
Muscle spasms100
 Placebo (n=193)
AEsAll grades
(%)
Grades ≥3
(%)
Skin and subcutaneous tissue disorders  
HFSR/Palmar-plantar erythrodysesthesia (HFSR/PPES)7<1
General disorders and administration site conditions  
Pain448
Asthenia/Fatigue335
Fever70
Vascular disorders  
Hypertension65
Hemorrhage168
Gastrointestinal disorders  
Diarrhea150
Nausea130
Vomiting7<1
Mucositis2≤1
Respiratory, thoracic, and mediastinal disorders  
Dysphonia20
Infections and infestations  
Infection186
Metabolism and nutrition
disorders
  
Decreased appetite and food intake152
Investigations  
Weight loss40
Musculoskeletal and
connective tissue disorders
  
Muscle spasms20
  • The median duration of therapy was 3.5 months (range: 1 day to 29.4 months) for patients receiving STIVARGA
  • 58.3% of patients receiving STIVARGA required dose interruptions for AEs
    • 48% of patients receiving STIVARGA had their doses reduced due to AEs
  • 10.4% of STIVARGA-treated patients reported AEs that resulted in discontinuation vs 3.6% of patients who received placebo

Selected common TEAEs occurred during the first cycle of treatment with STIVARGA1,2

  • The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo treated patients in HCC, respectively, were pain (55% vs 44%), HFSR/PPES (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), and decreased appetite and food intake (31% vs 15%)1‡

Median time to onset and worst grade of selected TEAEs2

STIVARGA (regorafenib) other AEs. Visit hcp.stivarga-us.com to see full safety and Prescribing Information, including Boxed Warning.

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