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U.S. Department of Health and Human Services

Safety

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Nexavar (Sorafenib) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

November 2013

Summary View

WARNINGS AND PRECAUTIONS

  • Impairment of Thyroid Stimulating Hormone (TSH) Suppression in DTC - Nexavar impairs exogenous thyroid suppression. In the DTC study, 99% of patients had a baseline thyroid stimulating hormone (TSH) level less than 0.5 mU/L. Elevation of TSH level above 0.5 mU/L was observed in 41% of Nexavar-treated patients as compared with 16% of placebo-treated patients… 

 

August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Risk of Dermatologic Toxicities
  • There have been reports of severe dermatologic toxicities, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These cases may be life-threatening. Discontinue Nexavar if SJS or TEN are suspected.
 
Drug-Induced Hepatitis
  • Sorafenib-induced hepatitis is characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death. Increases in bilirubin and INR may also occur. Monitor liver function tests regularly. In case of significantly increased transaminases without alternative explanation such as viral hepatitis or progressing underlying malignancy, discontinue Nexavar.
 

ADVERSE REACTIONS

  • Hand-foot skin reaction, rash, Stevens-Johnson syndrome, and toxic epidermal necrolysis

 

Adverse Reactions in HCC Study
  • Hypocalcemia was reported in 27% of Nexavar -treated patients and 15% of placebo-treated patients. CTCAE grade 3 hypocalcemia (6–7 mg /dL) occurred in 2% of Nexavar -treated patients and 1% of placebo-treated patients. CTCAE grade 4 hypocalcemia (<6 mg/dL) occurred in 0.4% of Nexavar -treated patients and in no placebo-treated patients.
 
Adverse Reactions in RCC Study 1
  • Hypocalcemia was reported in 12% of Nexavar -treated patients and 8% of placebo-treated patients. CTCAE grade 3 hypocalcemia (6–7 mg/dL) occurred in 1% of Nexavar-treated patients and 0.2% of placebo-treated patients, and CTCAE grade 4 hypocalcemia (<6 mg/dL) occurred in 1% of Nexavar -treated patients and 0.5% of placebo-treated patients.
 
Additional Data from Multiple Clinical Trials
Metabolic and Nutritional
  • hypocalcemia
 
Postmarketing Experience
  • Hypersensitivity: Angioedema, anaphylactic reaction
  • Musculoskeletal: Rhabdomyolysis
 

PATIENT COUNSELING

Drug Induced Hepatitis
  • Inform patients that Nexavar can cause hepatitis which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis
 

PATIENT INFORMATION

What are the possible side effects of Nexavar?
  • serious skin and mouth reactions… 
  • inflammation of your liver (drug-induced hepatitis)…