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 Advanced RCC

Safety in the TARGET Study

Indication 2 Button
  • Most adverse reactions were Grades 1 and 2: NEXAVAR 57%, placebo 58%
  • Grades 3 and 4 adverse reactions occurred at rates of 31% and 7% with NEXAVAR, respectively, and 22% and 6% with placebo, respectively
  • Discontinuation of NEXAVAR due to adverse reactions was 10% vs 8% for placebo
  • In the RCC study, the most common laboratory abnormalities observed in the NEXAVAR arm vs the placebo arm, respectively, were hypophosphatemia (45% vs 11%), anemia (44% vs 49%), elevated lipase (41% vs 30%), elevated amylase (30% vs 23%), lymphopenia (23% vs 13%), neutropenia (18% vs 10%), thrombocytopenia (12% vs 5%), hypocalcemia (12% vs 8%), and hypokalemia (5.4% vs 0.7%)

TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial): A randomized, double-blind, placebo-controlled, multicenter, Phase III study in patients with advanced RCC who had received 1 prior systemic therapy (N=903).2
NCI-CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Reactions.
HFSR=hand-foot skin reaction.

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.

REFERENCES:

1. NEXAVAR Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc. 2. Escudier B, Eisen T, Stadler WM, et al; for TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-134.