Nexavar is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Nexavar is used to treat liver cancer, thyroid cancer, or kidney cancer.

It is not known if Nexavar is safe and effective in children.

You should not use Nexavar if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel.

Nexavar can cause heart problems. Get emergency medical help if you have: chest pain, fast heartbeats, trouble breathing, or swelling around your midsection or in your lower legs.

Nexavar can also cause severe bleeding. Call your doctor if you have blood in your urine or stools, abnormal vaginal bleeding, severe stomach pain, cough with bloody mucus, or any bleeding that will not stop.

Before taking this medicine

You should not use Nexavar if you are allergic to sorafenib, or if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel.

To make sure Nexavar is safe for you, tell your doctor if you have:

• heart problems, chest pain, or a heart attack;

• long QT syndrome (in you or a family member);

• high blood pressure;

• an electrolyte imbalance (such as abnormal levels of calcium, magnesium, or potassium in your blood);

• bleeding problems; or

• surgery.

Sorafenib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Nexavar if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Nexavar.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Nexavar is usually taken 2 times per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Nexavar on an empty stomach, at least 1 hour before or 2 hours after eating.

Your blood pressure will need to be checked often.

If you need surgery, tell the surgeon or dentist ahead of time that you are using Nexavar. You should stop taking this medicine at least 10 days before having surgery. Follow your doctor's instructions about when to start taking the medicine again.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Thyroid Cancer:

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Hepatocellular Carcinoma:

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

You should not use Nexavar if you are allergic to sorafenib, or if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel.

To make sure Nexavar is safe for you, tell your doctor if you have:

• heart problems, chest pain, or a heart attack;

• long QT syndrome (in you or a family member);

• high blood pressure;

• an electrolyte imbalance (such as abnormal levels of calcium, magnesium, or potassium in your blood);

• bleeding problems; or

• surgery.

Sorafenib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Nexavar if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Nexavar.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Nexavar (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have symptoms of a heart attack or heart failure: chest pain, fast heartbeats, sweating, nausea, trouble breathing, feeling light-headed, or swelling around your midsection or in your lower legs.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;

• shortness of breath, sudden dizziness (like you might pass out);

• easy bruising or bleeding (nosebleeds, bleeding gums);

• heavy menstrual periods or unusual vaginal bleeding;

• pain, redness, swelling, rash, blisters or peeling in the palms of your hands or the soles of your feet;

• fever with nausea, vomiting, or severe stomach pain

• a surgical incision or wound that will not heal;

• liver problems - loss of appetite, stomach pain (upper right side), nausea, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of bleeding inside your body - pink or brown urine, abnormal vaginal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Nexavar side effects may include:

• bleeding;

• feeling tired;

• vomiting, diarrhea, nausea, stomach pain;

• high blood pressure;

• rash; or

• weight loss, thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with sorafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.