NEXAVAR® (sorafenib): Established safety profile

Adverse events (AEs) reported in ≥10% of patients and at a higher rate in the NEXAVAR arm vs placebo in SHARP1*

NEXAVAR safety profile1
  NEXAVAR (n=297) Placebo (n=302)
AEs All grades (%) Grade 3 (%) Grade 4 (%) All grades (%) Grade 3 (%) Grade 4 (%)
Any adverse reaction 98 39 6 96 24 8
Gastrointestinal            
Diarrhea 55 10 <1 25 2 0
Anorexia 29 3 0 18 3 <1
Nausea 24 1 0 20 3 0
Vomiting 15 2 0 11 2 0
Constipation 14 0 0 10 0 0
Constitutional symptoms            
Fatigue 46 9 1 45 12 2
Weight loss 30 2 0 10 1 0
Pain            
Pain, abdomen 31 9 0 26 5 1
Dermatology/skin            
Hand-foot skin reaction (HFSR) 21 8 0 3 <1 0
Rash/desquamation 19 1 0 14 0 0
Alopecia 14 0 0 2 0 0
Pruritus 14 <1 0 11 <1 0
Dry skin 10 0 0 6 0 0
Hepatobiliary/pancreas            
Liver dysfunction 11 2 1 8 2 1
  NEXAVAR (n=297)
AEs All grades (%) Grade 3 (%) Grade 4 (%)
Any adverse reaction 98 39 6
Gastrointestinal      
Diarrhea 55 10 <1
Anorexia 29 3 0
Nausea 24 1 0
Vomiting 15 2 0
Constipation 14 0 0
Constitutional symptoms      
Fatigue 46 9 1
Weight loss 30 2 0
Pain      
Pain, abdomen 31 9 0
Dermatology/skin      
Hand-foot skin reaction (HFSR) 21 8 0
Rash/
desquamation
19 1 0
Alopecia 14 0 0
Pruritus 14 <1 0
Dry skin 10 0 0
Hepatobiliary/
pancreas
     
Liver dysfunction 11 2 1
  Placebo (n=302)
AEs All grades (%) Grade 3 (%) Grade 4 (%)
Any adverse reaction 96 24 8
Gastrointestinal      
Diarrhea 25 2 0
Anorexia 18 3 <1
Nausea 20 3 0
Vomiting 11 2 0
Constipation 10 0 0
Constitutional symptoms      
Fatigue 45 12 2
Weight loss 10 1 0
Pain      
Pain, abdomen 26 5 1
Dermatology/skin      
Hand-foot skin reaction (HFSR) 3 <1 0
Rash/
desquamation
14 0 0
Alopecia 2 0 0
Pruritus 11 <1 0
Dry skin 6 0 0
Hepatobiliary/
pancreas
     
Liver dysfunction 8 2 1

*AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0.

*AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0.

The safety profile of NEXAVAR is as well established as its efficacy, as demonstrated in the SHARP trial1

  • Similar discontinuation rates due to AEs in the SHARP trial: 32% with NEXAVAR vs 35% with placebo

  • Most AEs were Grade 1 or 2 with NEXAVAR

    • Grade 3 AEs were experienced in 39% of patients treated with NEXAVAR vs 24% of patients treated with placebo

    • Grade 4 AEs were experienced in 6% of patients treated with NEXAVAR vs 8% of patients treated with placebo

  • The most common AEs reported for NEXAVAR-treated patients vs placebo in unresectable HCC, respectively, were diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and HFSR (21% vs 3%)

Find out dosing strategies for your patients

Dosing for NEXAVAR is well defined

Monitor patients early and often: NEXAVAR oral systemic therapy dosing and administration guidelines1

  • The recommended dosage of NEXAVAR is 400 mg orally taken twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs

  • Impaired wound healing can occur in patients who receive drugs that inhibit the VEGF signaling pathway. Therefore, NEXAVAR has the potential to adversely affect wound healing. Withhold NEXAVAR for at least 10 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of NEXAVAR after resolution of wound healing complications has not been established

  • Temporary interruption or permanent discontinuation of NEXAVAR may be required for the following: cardiac ischemia or infarction, congestive heart failure, hemorrhage requiring medical intervention, severe or persistent hypertension, gastrointestinal perforation, QTc prolongation, drug-induced liver injury, or nonhematological toxicity

  • When dose reduction is necessary for HCC, the NEXAVAR dosage may be reduced to 400 mg once daily. If additional dose reduction is required, NEXAVAR may be reduced to a single 400-mg dose every other day

  • No starting dose adjustment is necessary for mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment