Nexavar (Sorafenib) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012
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.
- 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.
- 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
- Hypersensitivity: Angioedema, anaphylactic reaction
- Musculoskeletal: Rhabdomyolysis
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
What are the possible side effects of Nexavar?
- serious skin and mouth reactions…
- inflammation of your liver (drug-induced hepatitis)…