IMPORTANT SAFETY INFORMATION:
NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR. Continue reading below

NEXAVAR in unresectable HCC

NEXAVAR® (sorafenib) experience from the SHARP trial

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

  • Similar discontinuation rates due to adverse events (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 hand-foot skin reaction (21% vs 3%)

Safety information from the SHARP trial

NEXAVAR® (sorafenib) Safety Information in a Phase III Trial NEXAVAR® (sorafenib) Safety Information in a Phase III Trial

NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.


Dosing for NEXAVAR® (sorafenib) is well defined

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

NEXAVAR® (sorafenib) Dosing Checklist NEXAVAR® (sorafenib) Dosing Checklist

Indications

NEXAVAR is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Important Safety Information

For important risk and use information about NEXAVAR, please see the full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION for STIVARGA® (regorafenib)

For important risk and use information about STIVARGA, please see the full Prescribing Information including the Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

REFERENCE:

1. NEXAVAR Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc; 2015.