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 »

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.

References: 1. Davila JA, Henderson L, Kramer JR, et al. Utilization of surveillance for hepatocellular carcinoma among hepatitis C virus-infected veterans in the United States. Ann Intern Med. 2011;154:85-93. 2. Bruix J, Sherman M, Llovet JM, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. J Hep. 2001;35(3):421-430. 3. Bruix J, Sherman M. Management of Hepatocellular Carcinoma: An Update. Alexandria, VA: American Association for the Study of Liver Diseases. http://www.aasld.org/practiceguidelines. 2010. 4. National Comprehensive Cancer Network, Inc. The NCCN Clinical Practice Guidelines in Oncology™. Hepatobiliary Cancers (Version 2.2010). NCCN Web site http//:www.NCCN.org. Accessed December 3, 2010. 5. Omata M, Lesmana LA, Tateishi R, et al. Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma. Hepatol Int. 2010;4:439-474. 6. American Cancer Society. Detailed Guide: Liver Cancer. What are the risk factors for liver cancer? ACS Web site. http://www.cancer.org. Updated December 7, 2008. Accessed April 28, 2009. 7. El-Serag HB, Rudolph KL. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. In: Reviews in basic and clinical gastroenterology. El-Diery W, Metz D, Reddy KR, eds. Gastroenterology. 2007;132(7):2557-2576. 8. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hep. 2006;45:529-538. 9. Mendler M. Fatty liver: nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Medicinenet.com Web site. http://www.medicinenet.com/fatty_liver/article.htm. Accessed April 23, 2009. 10. Cancer Research UK. Risks and causes of liver cancer. CancerHelp UK Web site http://www.cancerhelp.org.uk/help/default.asp?page=4897. Updated February 13, 2009. Accessed April 23, 2009. 11. Giordano TP, Kramer JR, Souchek J, Richardson P, El-Serag HB. Cirrhosis and hepatocellular carcinoma in HIV-infected veterans with and without the hepatitis C virus: a cohort study, 1992-2001. Arch Intern Med. 2004;164(21):2349-2354.