Sorafenib tosylate Oral tablet

What is this medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• bleeding problems

• heart disease

• high blood pressure

• kidney disease

• liver disease

• lung cancer

• recent 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 medicine?

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 medicine?

This medicine may interact with the following medications:

• carbamazepine

• dexamethasone

• medicines for seizures like carbamazepine, phenobarbital, phenytoin

• neomycin

• rifabutin

• rifampin

• St. John's Wort

• warfarin

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 medicine?

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.

Men and women should use effective birth control while taking this medicine and for 2 weeks after stopping this medicine. Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. 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.

If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine.

What side effects may I notice from receiving this medicine?

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 medicine?

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.