IMPORTANT SAFETY INFORMATION

NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar. Cardiac ischemia and/or myocardial infarction may occur. continue reading below »

Overall survival consistent with SHARP Trial

In the Asia-Pacific Study*, Nexavar extended overall survival (OS) by 47% vs placebo¹

HR=hazard ratio; CI=confidence interval.

Improvement in OS for the patients randomized to sorafenib in the Asia-Pacific Study was consistent with the SHARP^† Trial as indicated by hazard ratios for survival (HR: 0.68 and 0.69, respectively)^1,2
Like the SHARP Trial, the Asia-Pacific Study was stopped early and patients taking placebo crossed over to receive Nexavar¹

Adverse reactions highlights from the AP study

The most common adverse reactions for Nexavar vs placebo in this study, respectively, were: hand-foot skin reaction (HFSR) (45% vs 2.7%), diarrhea (25.5% vs 5.3%), alopecia (24.8% vs 1.3%), fatigue (20.1% vs 8.0%), rash/desquamation (20.1% vs 6.7%), and hypertension (18.8% vs 1.3%). These events were primarily Grade 1/2
The most common adverse reactions resulting in dose reductions were HFSR (11.4%) and diarrhea (7.4%)

Indication

Nexavar is indicated for the treatment of patients with unresectable hepatocellular carcinoma.

Important Safety Considerations

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer
Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar
Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction
Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar
Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials
An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar
Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required
Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures
Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities
Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Monitor patients taking concomitant warfarin regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib. Nexavar exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied
Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients 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%). Grade 3/4 adverse reactions were 45% vs 32%
During postapproval use of Nexavar, the following adverse drug reactions have been identified: angioedema and drug-induced hepatitis, including reports of hepatic failure and death

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1.800.FDA.1088. For important risk and use information, please see the full Prescribing Information.

*Asia-Pacific (AP) Liver Cancer Study: A randomized, double-blind, placebo-controlled, multicenter, phase 3 study conducted in patients with advanced (unresectable or metastatic) HCC in China, Taiwan, and South Korea (N=226). Patients who had not received previous systemic therapy were randomly assigned to Nexavar 400 mg po bid (n=150) or placebo (n=76) in a 2:1 ratio.

^†SHARP (Sorafenib HCC Assessment Randomized Protocol Trial): A randomized, double-blind, placebo-controlled, international, multicenter, phase 3 study in patients with unresectable HCC (N=602).

References: 1. Cheng AL, Yang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomized, double-blind, placebo-controlled trial. Lancet Oncol. 2009;10(1):25-34. 2. Llovet JM. Ricci S, Mazzaferro V, et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378-390.