When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to sorafenib, or if you are pregnant.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach at least 1 hour before or 2 hours after a meal.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, skip the missed dose and go back to your regular schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how sorafenib works. Tell your doctor if you are using St John's wort, carbamazepine, dexamethasone, neomycin, phenobarbital, phenytoin, rifabutin, rifampin, a blood thinner (such as warfarin), medicine for heart rhythm problems, or if you have ever been treated with cancer drugs.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Both men and women must use an effective form of birth control during treatment and for at least 2 weeks after stopping treatment.
• Tell your doctor if you are breastfeeding, or have kidney problems, liver problems, bleeding problems, heart disease, congestive heart failure, heart rhythm problems, high blood pressure, or thyroid problems.
• This medicine may cause the following problems:
  
  • Heart problems (angina, heart attack)
  • High risk of bleeding and delayed wound healing
  • High blood pressure
  • Serious skin reactions
  • Stomach or bowel damage
  • Heart rhythm problems
  • Liver problems (hepatitis)
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your blood pressure should also be checked regularly.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, lightheadedness, or dizziness
• Fast, slow, pounding, or uneven heartbeat
• Numbness, tingling, or pain in your hands or feet
• Red or black stools, severe stomach pain
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Unusual bleeding, bruising, or weakness
• Vomiting of blood or material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Hair thinning or patchy hair loss
• Mild nausea, vomiting, diarrhea, or stomach pain
• Weight loss

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088