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. continue reading below »

Treatment Options for Advanced Kidney Cancer

Surgery is the most common treatment for kidney cancer.¹ There are several types of surgery that can be done depending on each individual patient. These include¹:

Radical nephrectomy—The surgeon removes the entire kidney along with the adrenal gland and some tissue around the kidney
Regional lymphadenectomy—Sometimes performed in addition to the radical nephrectomy, a regional lymphadenectomy removes nearby lymph nodes to see whether the cancer has spread to them
Partial nephrectomy—the surgeon removes the part of the kidney that contains the tumor
Laparoscopic nephrectomy—A surgeon makes small incisions, or cuts, then inserts a small laparoscope into 1 incision to see the kidney and uses the other incision for instruments
Removal of metastases—A quarter of patients diagnosed with advanced kidney cancer already have metastatic spread of cancer.² Surgical removal of metastases is sometimes possible to relieve pain and other symptoms of metastatic disease

Other therapies are available in addition to surgery. These include^1,3:

Radiation therapy—High-energy rays are used to kill cancer cells and shrink the tumor
Immunotherapy/biologic therapy—Medicine that travels throughout the body and uses the body's own immune system to fight cancer
Other therapies —Other therapies that interrupt the signals in the body that cause normal and cancer cells to grow and multiply

Indication

NEXAVAR is an anticancer medicine used to treat a certain type of kidney cancer called advanced renal cell carcinoma (RCC), or a certain type of liver cancer known as hepatocellular carcinoma (HCC), when it cannot be treated with surgery.

Important Safety Information

Do not take Nexavar if you have a specific type of lung cancer (squamous cell) and receive carboplatin and paclitaxel. Before starting NEXAVAR, tell your doctor if you have: allergies; heart problems (including a problem called congenital long QT syndrome) 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.
– changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your doctor right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast while taking Nexavar.

The most common side effects with NEXAVAR may 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.

References: 1. American Cancer Society. Overview: kidney cancer. How is kidney cancer treated? ACS Web site. http://www.cancer.org/docroot/CRI/content/CRI_2_2_4x_Treatment_for_kidney_cancer_22.asp?sitearea=. Updated May 6, 2009. Accessed August 26, 2009. 2. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009;27(20):3312-3318. 3. National Cancer Institute, US National Institutes of Health. Renal cell cancer (PDQ^®): treatment patient version. NCI Web site. http://www.cancer.gov/cancertopics/pdq /treatment /renalcell/patient/allpages. Updated June 18, 2008. Accessed August 14, 2009.