Indication

NEXAVAR (sorafenib) 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

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.

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.
• serious skin and mouth reactions. Tell your doctor if you have skin rash, blistering and peeling of the skin, blistering and peeling on the inside of your mouth.
• an opening in the wall of your stomach or intestines (perforation of the bowel). Tell your doctor right away if you get high fever, nausea, vomiting or abdominal (stomach) 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.
• inflammation of your liver (drug-induced hepatitis). Your doctor may stop your treatment with NEXAVAR if you develop changes in certain liver function tests. Call your doctor right away if you develop yellowing of the skin or white part of your eyes (jaundice), dark "tea-colored" urine, light-colored bowel movements (stools), worsening nausea, worsening vomiting, abdominal pain.

The most common side effects with NEXAVAR may include: rash, redness, itching or peeling skin; hair thinning or loss; diarrhea; nausea/vomiting; loss of appetite; 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.