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

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

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

Sorafenib 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.

Sorafenib 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take sorafenib 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 sorafenib. 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 sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel.

Tell your doctor if you have ever had:

• 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 sorafenib.

• If you are a woman, do not use sorafenib 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 sorafenib.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (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.

Sorafenib may cause serious side effects. 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 side effects of sorafenib 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 affect 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sorafenib. Your doctor will also check your blood pressure every week during the first six weeks of your treatment and then from time to time as needed.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.