Nexavar (Sorafenib Tosylate)

(soe raf' e nib)

Sorafenib is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the kidneys). Sorafenib is also used to treat hepatocellular carcinoma (a type of liver cancer) that cannot be treated with surgery and a certain type of thyroid cancer that has spread to other parts of the body and cannot be treated with radioactive iodine. Sorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply.This helps stop the spread of cancer cells.

Sorafenib comes as a tablet to take by mouth. It is usually taken twice a day. Sorafenib is taken without food, 1 hour before or 2 hours after a meal. Take sorafenib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sorafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the tablets whole with water. Do not split, chew, or crush them. Your doctor may decrease your dose of sorafenib during your treatment, or may tell you to stop taking sorafenib for a period of time if you experience side effects. Be sure to tell your doctor how you are feeling during your treatment with sorafenib. Continue to take sorafenib even if you feel well. Do not stop taking sorafenib without talking to your doctor. Sorafenib is not available in pharmacies. You can only get sorafenib through the mail from a specialty pharmacy. Ask your doctor if you have any questions about receiving your medication. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking sorafenib,
• tell your doctor and pharmacist if you are allergic to sorafenib, any other medications, or any of the ingredients in sorafenib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you have lung cancer and are receiving treatment with carboplatin (Paraplatin) and paclitaxel (Abraxane, Onxol, Taxol) or gemcitabine (Gemzar) and cisplatin (Platinol). Your doctor will probably tell you not to take sorafenib if you have lung cancer and you are receiving these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone);anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven), carbamazepine (Equetro, Tegretol), dexamethasone, dofetilide (Tikosyn), dronedarone (Multaq), ibutilide (Corvert), irinotecan (Camptosar), neomycin, phenobarbital, phenytoin (Dilantin, Phenytek), procainamide (Procanbid, Pronestyl); quinidine; rifabutin (Mycobutin), or rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had high blood pressure, bleeding problems, chest pain, heart problems, kidney problems other than kidney cancer, or liver disease.
• you should know that sorafenib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking sorafenib and for at least 2 weeks after your treatment. Use a reliable method of birth control during your treatment and for 2 weeks after you stop taking sorafenib. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking sorafenib, call your doctor immediately. Sorafenib may harm the fetus.
• tell your doctor if you are breast-feeding or plan to breast-feed. You should not breast-feed while taking sorafenib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sorafenib.

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

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Sorafenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• weakness
• skin redness
• hair loss
• itching
• dry or peeling skin
• loss of appetite
• constipation
• diarrhea
• dry mouth
• weight loss
• joint pain
• numbness, pain or tingling in hands or feet
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual bruising or bleeding
• black and/or tarry stools
• red blood in stools
• bloody vomit
• vomiting material that looks like coffee grounds
• fever
• severe stomach pain
• nausea
• vomiting
• chest pain
• shortness of breath
• dizziness or fainting
• sweating a lot
• fast, pounding, or irregular heartbeat
• sudden severe headache
• confusion
• changes in vision
• seizures
• rash
• redness, pain, swelling or blisters on the palms of the hands or soles of the feet
• mouth sores
• dark urine
• yellowing of the skin or eyes
• pain in the upper right part of the stomach

Sorafenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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). 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. 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

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.