Sorafenib (By mouth)

Introduction

Sorafenib (soe-RAF-e-nib)

Treats late-stage kidney cancer and liver cancer that cannot be treated with surgery.

Brand Name(s)

Nexavar

When This Medicine Should Not Be Used

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 of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may also receive medicines to help prevent nausea and vomiting.
• Take this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal).
• Swallow the tablet whole with water. Do not crush, break, or chew it.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
• If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you also use a blood thinner (such as warfarin, Coumadin®) or medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®). Tell your doctor if you use dexamethasone (Decadron®), neomycin (Mycifradin®), rifabutin (Mycobutin®), rifampin (Rifadin®), or St. John's wort or if you have ever been treated with cancer drugs (such as docetaxel, doxorubicin, fluorouracil/leucovorin, irinotecan, Adriamycin®, Adrucil®, Camptosar®, Rubex®, or Taxotere®).
• Tell your doctor if you also use arsenic trioxide (Trisenox®), cisapride (Propulsid®), medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Procanbid®, Quinaglute®, or Tikosyn®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Levaquin®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. In addition, use effective birth control for at least 2 weeks after you stop treatment.
• Make sure your doctor knows if you have kidney or liver problems, bleeding problems, heart disease, congestive heart failure, heart rhythm problems (such as congenital long QT syndrome, QT prolongation, slow heartbeat), high blood pressure, stomach or bowel problems, or a mineral imbalance (such as high or low calcium, magnesium, or potassium).
• This medicine may cause serious heart problems. Stop using this medicine and check with your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in your arms, jaw, back or neck; shortness of breath; sweating; or vomiting.
• This medicine may increase your chance of bleeding and cause wounds to heal more slowly. Avoid rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when you use sharp objects, including razors and fingernail clippers.
• This medicine may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet. Your doctor may adjust the dose or stop treatment for a short time.
• Tell your doctor right away if you have severe stomach pain, bloody or black tarry stools, fever, heartburn, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause you to faint or have serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your blood pressure should be checked weekly, especially during the first 6 weeks of starting this medicine. Your doctor may need to treat you if you develop high blood pressure while you are using this medicine.

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
• Blurred vision
• Chest pain or discomfort
• Dizziness, lightheadedness, or fainting
• Fast, slow, pounding, or uneven heartbeat
• Nausea, vomiting, fever, loss of appetite, or pain in your upper stomach that may be sudden and severe
• Numbness, tingling, or pain in your hands or feet
• Red or black stools
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Shortness of breath
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds

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

• Dry skin, rash, redness, or itching
• Hair thinning or patchy hair loss
• Mild nausea, vomiting, diarrhea, constipation, 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