Sorafenib Oral Tablet

What is this medication?

SORAFENIB (soe RAF e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat liver cancer, kidney cancer, and thyroid cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nexavar

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• heart disease
• history of irregular heartbeat
• high blood pressure
• liver disease
• having surgery
• an unusual or allergic reaction to sorafenib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after meals. Do not take with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may interact with the following medications:

• carbamazepine
• dexamethasone
• digoxin
• loperamide
• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
• phenobarbital
• phenytoin
• quinidine
• rifampin
• rifabutin
• St. John's Wort
• vinblastine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

You may need blood work done while you are taking this medicine.

This medicine should be started at least 2 weeks following major surgery and the site of the surgery should be totally healed. Check with your doctor before scheduling dental work or surgery while you are receiving this treatment. Talk to your doctor if you have recently had surgery or if you have a wound that has not healed.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black, tarry stools
• breathing problems
• chest pain or chest tightness
• dark urine
• dizziness
• fast or irregular heartbeat
• feeling faint or lightheaded
• high fever
• light-colored stools
• nausea, vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• right upper belly pain
• sores on the hands or feet
• spitting up blood or brown material that looks like coffee grounds
• stomach pain
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• hair loss
• loss of appetite
• tiredness
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.