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 locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine therapy

Safety in the DECISION Study

  • In the DTC study, the most common laboratory abnormalities observed in the NEXAVAR arm vs the placebo arm, respectively, were elevated ALT (59% vs 24%), elevated AST (54% vs 15%), and hypocalcemia (36% vs 11%).The relative increase for the following laboratory abnormalities observed in NEXAVAR-treated DTC patients as compared to placebo-treated patients is similar to that observed in the RCC and HCC studies: lipase, amylase, hypokalemia, hypophosphatemia, neutropenia, lymphopenia, anemia, and thrombocytopenia

DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer) study:
A randomized, double-blind, placebo-controlled, multicenter, Phase III study in patients with locally recurrent or metastatic, progressive,
DTC refractory to RAI (N=417).2

ALT=alanine transaminase; AST=aspartase transaminase.

*Between–arm difference ≥5% [all Grades] or ≥2% [Grades 3 and 4]. Grade refers to severity of adverse reaction per National Cancer Institute Common Terminology Criteria for Adverse Reactions Version 3.0.

Includes the following terms: abdominal pain, abdominal discomfort, hepatic pain, esophageal pain, esophageal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, abdominal rigidity.

Includes the following terms: stomatitis, aphthous stomatitis, mouth ulceration, mucosal inflammation.

§Includes the following terms: oral pain, oropharyngeal discomfort, glossitis, burning mouth syndrome, glossodynia.

||Includes the following terms: Palmar–plantar erythrodysesthesia (hand–foot skin reaction).

Includes the following terms: hypertension, blood pressure increased, blood pressure systolic increased.

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. Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014;384(9940):319-328.