References

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  1. Escudier B, Szczylik C, Eisen T, et al. Randomized phase III trial of the multiple kinase inhibitor sorafenib (BAY 43-9006) in patients with advanced RCC. Paper presented at: ECCO 13—the European Cancer Conference; November 3, 2005; Paris, France.
  2. Data on file, Bayer Pharmaceuticals Corporation, 2006.
  3. Grotzinger J. Molecular mechanisms of cytokine receptor activation. Biochem Biophys Acta 2002;1592:215-223.
  4. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64:7099-7109.
  5. Kim WY, Kaelin WG. Role of VHL gene mutation in human cancer. J Clin Oncol. 2004;22:4991-5004.
  6. Adjei AA, Hidalgo M. Intracellular signal transduction pathway proteins as targets for cancer therapy. J Clin Oncol. 2005;23:5386-5403.
  7. Ward JF, et al. Does preservation of the neurovascular bundle affect surgical outcome in men with prostate cancer? Available at: http://www.nature.com/ncpuro/journal/v2/n3/full/ncpuro0117.html .
  8. Cancer Therapy Evaluation Program—National Cancer Institute web site. Common terminology criteria for adverse events, v3.0 (CTCAE). Available at: http://ctep.cancer.gov/forms/CTCAEv3.pdf.
  9. Motzer RJ, Bander NH, Nanus DM. Renal-cell carcinoma. N Engl J Med. 1996;335:865–875.
  10. IARC, 2002, http://www-dep.iarc.fr/.
  11. Yuan JM, Castelao JE, Gago-Dominguez M, Ross RK, Yu MC., Hypertension, obesity and their medications in relation to renal cell carcinoma. Br J Cancer. 1998 May;77(9):1508-13. Department of Preventive Medicine, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles 90033-0800, USA.
  12. Manuela Gago-Dominguez, Jian-Min Yuan, J. Esteban Castelao, Ronald K. Ross and Mimi C. Yu, Family History and Risk of Renal Cell Carcinoma, Cancer Epidemiology Biomarkers & Prevention Vol. 10,1001-1004, September 2001, Department of Preventive Medicine, University of Southern California/Norris Comprehensive Cancer Center, University of Southern California School of Medicine, Los Angeles, California 90033-0800
  13. Pesch B, Haerting J, Ranft U, Klimpel A, Oelschlagel B, Schill W. Occupational risk factors for renal cell carcinoma: agent-specific results from a case-control study in Germany. MURC Study Group. Multicenter urothelial and renal cancer study. Int J Epidemiol. 2000;29(6):1014-24
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  15. Stetler-Stevenson WG, Kleiner DE Jr. Molecular biology of cancer: invasion and metastases. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 6th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:123-136.
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  18. Linehan WM, Bates SE, Yang JC. Cancers of the Genitourinary System: cancer of the kidney. In: DeVita VT Jr, Helman S, Rosenberg, SA, eds, Cancer: Principles & Practice of Oncology. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2005:1139–1168.
  19. National Foundation for Cancer Research. Kidney Cancer FAQs.
  20. American Cancer Society. How Is Kidney Cancer (Renal Cell Carcinoma) Staged?.
  21. American Cancer Society. What is Kidney Cancer?
  22. American Cancer Society. What is Cancer?
  23. American Cancer Society. What are the Risk Factors for Kidney Cancer?.
  24. American Cancer Society. How is Kidney Cancer (Renal Cell Carcinoma) Diagnosed?
  25. National Cancer Institute. Stages of Renal Cell Cancer.
  26. eMedicine. Transperitoneal Laparoscopic Radical Nephrectomy
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Next: Patient Prescribing Information
 
Term
Explanation for term.

Indications and Usage

NEXAVAR is an anticancer medicine used to treat a certain type of liver or kidney cancer called:
- Hepatocellular carcinoma (HCC), when it cannot be treated with surgery
- Renal cell carcinoma (RCC, a type of kidney cancer).

Important Safety Information

NEXAVAR may cause birth defects or death of an unborn baby. Avoid becoming pregnant while taking NEXAVAR and for at least 2 weeks after stopping your treatment. Men and women should use birth control during and at least 2 weeks after NEXAVAR therapy. Call your doctor right away if you become pregnant. Do not breastfeed while taking NEXAVAR as this medication may be passed through breast milk.

Before starting NEXAVAR, tell your doctor if you have: allergies; heart problems or chest pain; bleeding or bruising problems; high blood pressure; or kidney or liver problems. NEXAVAR may interact with certain other medicines so tell your doctor about all medicines you take including prescription and over-the-counter (OTC) medicines, vitamins, or herbal supplements.It is especially important to tell your doctor if you take warfarin (Coumadin).

NEXAVAR may cause serious side effects, including:

-Decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, shortness of breath, feel lightheaded or faint, have nausea or vomiting, or you are sweating a lot.

-Bleeding problems. Tell your doctor if you have any bleeding or easy bruising while taking NEXAVAR.

-High blood pressure. Your blood pressure should be checked every week during the first 6 weeks of starting therapy and then regularly, thereafter. If your blood pressure is high, it may need to be treated.

-A skin problem called hand-foot skin reaction. This causes redness, pain, swelling or blisters on the palms of your hands and soles of your feet. Your doctor may change your dose or stop treatment for a while.

-Perforation of the bowel. Tell your doctor right away if you get high fever, nausea, vomiting or abdominal pain.

-Wound healing problems. If you have a surgical or dental procedure, tell your doctor you are taking NEXAVAR. Your treatment may be stopped until after your surgery or until your wound heals.

Other side effects with NEXAVAR can include: rash, redness, itching or peeling skin; hair thinning or loss; diarrhea; nausea/vomiting; mouth sores; weakness; loss of appetite; numbness, tingling or pain in hands and feet; abdominal pain; tiredness; or weight loss. Tell your doctor if you have any side effects that bother you or do not go away.

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 patient prescribing information.