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Brand Names: Nexavar

Generic Name: sorafenib (Pronunciation: sor a FEN ib)

• What is sorafenib (Nexavar)?
• What are the possible side effects of sorafenib (Nexavar)?
• What is the most important information I should know about sorafenib (Nexavar)?
• What should I discuss with my health care provider before taking sorafenib (Nexavar)?
• How should I take sorafenib (Nexavar)?
• What happens if I miss a dose (Nexavar)?
• What happens if I overdose (Nexavar)?
• What should I avoid while taking sorafenib (Nexavar)?
• What other drugs will affect sorafenib (Nexavar)?
• Where can I get more information?

What is sorafenib (Nexavar)?

Sorafenib is a cancer (chemotherapeutic) medication. Sorafenib interferes with the growth of cancer cells and slows their growth and spread in the body.

Sorafenib is used to treat a type of kidney cancer called advanced renal cell carcinoma. It is also used to treat liver cancer.

Sorafenib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sorafenib (Nexavar)?

Stop using sorafenib and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• easy bruising, unusual bleeding;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• sudden numbness or weakness, especially on one side of the body; or
• confusion, loss of balance or coordination, or seizure (convulsions).

Less serious side effects may include:

• numbness, tingling, or swelling of your hands or feet;
• nausea, vomiting, constipation, diarrhea, stomach pain, loss of appetite;
• headache, tired feeling;
• tumor pain;
• pain in your joints, bones, or mouth;
• cough, trouble breathing;
• weight loss;
• hair loss; or
• dry, itchy skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sorafenib (Nexavar)?

Sorafenib can cause high blood pressure (hypertension). Before using this medication, tell your doctor if you have a history of hypertension. Your blood pressure will need to be checked on a regular basis while you are using sorafenib.

Call your doctor at once if you have serious side effects such as rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet; unusual bruising or bleeding; chest pain spreading to the arm or shoulder; feeling short of breath; or sudden numbness or weakness.

Using sorafenib while you are pregnant can cause harm to the unborn baby. Do not use this medication if you are pregnant. Tell your doctor if you become pregnant during treatment. Both men and women taking sorafenib should use an effective form of birth control while taking the medication and for at least 2 weeks after treatment ends.