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 »

Hand-Foot Skin Reaction (HFSR)

HFSR is the name for a group of symptoms that affect the hands and/or feet of patients taking certain cancer therapies. Usually the symptoms affect both the left and right sides of the body.¹

The symptoms listed below may occur one at a time, at the same time, or not at all.

Common symptoms of HFSR include^1-3:

Numbness, tingling, or a "pins and needles" feeling
Sensitivity to hot objects
Pain or tenderness
Burning sensation
Redness
Swelling
Buildup of hard skin or calluses at pressure points, such as the heels or
balls of your feet
Blistering
Dry and/or cracked skin
Peeling and/or flaking skin

Avoiding activities that cause friction or involve heat may help you manage or even prevent HFSR from getting worse. The following are activities or items you should avoid²:

Prolonged contact with hot water when washing dishes or bathing. Do not use rubber gloves to clean with hot water because the rubber can trap the heat against your skin
Contact with harsh chemicals from household cleaning products
Exposure to heat, including saunas, sunbathing, or sitting in front of a sunny window
Activities that result in friction on your feet; for example, jogging, aerobics, or taking long walks
Activities that involve friction on the hands, such as the use of tools or utensils that involve pressing your hand against a hard surface, for example gardening tools, knives, or screwdrivers

If symptoms develop, your doctor or health care professional will decide how they should be managed. Depending on your symptoms, your doctor may decide to refer you to a skin doctor, called a dermatologist. Below are some suggestions your doctor may recommend that you follow^3,4:

Wear cotton socks or gel inserts and avoid pressure points by wearing soft shoes or tennis shoes and not standing for long periods of time^5,6
Use creams or lotions on your hands or feet. Apply either twice daily or overnight as a generous layer which can be covered with gloves or socks

Ask your doctor for recommendations on appropriate creams, lotions, or ointments to apply.

It is important to tell your doctor or health care professional as soon as you notice any signs or symptoms of HFSR because treating these symptoms early when they are still mild may prevent them from getting worse.

If you develop HFSR, your doctor will decide how to manage your symptoms. If the symptoms get worse, your doctor may need to temporarily interrupt treatment, reduce your treatment dose, or, in serious cases, take you off therapy. HFSR may improve or resolve over time. If interrupting treatment is required, you and your doctor will decide when to resume treatment. Your doctor may decide to refer you to a dermatologist, depending on your symptoms.

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. Robert C, Soria J-C, Spatz A, et al. Cutaneous side-effects of kinase inhibitors and blocking antibodies. Lancet Oncol. 2005;6(7):491-500. 2. Cancer.net. Hand-foot syndrome or palmar-plantar erythrodysesthesia. ASCO Web site. http://www.cancer.net /patient/Diagnosis+and+Treatment/Treating+Cancer/Managing+Side+Effects/Hand-Foot+ Syndrome+or+Palmar-Plantar+Erythrodysesthesia#mainContent%20idmainContent. Updated June 25, 2009. Accessed August 26, 2009. 3. Wood LS. Managing the side effects of sorafenib and sunitinib. Commun Oncol. 2006;3(9):558-562. 4. Lacouture ME, Wu S, Robert C, et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist. 2008;13(9):1001-1011.
5. Cancer.net. Skin reactions to targeted therapies. ASCO Web site. http://www.cancer.net/patient/Coping/Emotional+and+Physical+Matters/Managing+Side+Effects/Skin+
Reactions+to+Targeted+Therapies#mainContent%20idmainContent. Updated April 6, 2008. Accessed April 7, 2008. 6. Data on file, Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ.
7. Caring4Cancer Web site. Hand-foot syndrome. http://www.caring4cancer.com/go/cancer/effects/lesscommon/handfoot-syndrome.htm. Updated March 17, 2008. Accessed June 2, 2009.