Sorafenib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain types of cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a skin problem, high blood pressure, or increase your risk for bleeding. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy

Generic and brand names: sorafenib, oral; Nexavar

What is this medicine used for?

This medicine is taken by mouth to treat certain types of:

• Kidney cancer
• Liver cancer
• Thyroid cancer

It is used when other cancer medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems
• Heart disease or chest pain
• High blood pressure
• Liver or kidney disease (other than cancer)
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Lung cancer

Tell your healthcare provider if you are scheduled to have surgery.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 2 weeks after you stop treatment. Do not breast-feed while you are taking this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine and for at least 2 weeks after you stop taking it.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine 1 hour before or 2 hours after food. Swallow the tablets whole with water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe diarrhea, skin rash, redness, swelling, blistering.

What should I watch out for?

You need to have your blood pressure checked and blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may cause high blood pressure, or increase your risk for bleeding. Contact your healthcare provider right away if you have unusual bruising or bleeding, dark or bloody urine or bowel movements, headache, dizziness, or weakness.

This medicine may cause a skin problem called hand-foot skin reaction. Contact your healthcare provider if you have redness, pain, swelling or blisters on the palms of your hands or the soles of your feet. Your dose of this medicine may need to be changed if this happens.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unexplained bruising or bleeding; blood in the urine; chest pain; fast or irregular heartbeat; fainting; shortness of breath; unusual sweating; headache; dizziness; unexplained weakness fever; yellowing of your skin or eyes; dark urine; light-colored bowel movements; loss of appetite; severe stomach pain; unusual tiredness; nausea; vomiting

Other: Pain, redness, swelling or blisters on the palms of your hands or soles of your feet; itchy peeling skin; tiredness; diarrhea; hair loss; joint and muscle pain; tingling or numbness in your hands or feet.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone; Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), mexiletine, procainamide, propafenone (Rythmol) and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), chloramphenicol, ciprofloxacin (Cipro), erythromycin (E.E.S., Ery-Tab, Erythrocin), neomycin (Neo-Fradin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), moxifloxacin (Avelox), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Corticosteroids such as betamethasone (Celestone), dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Digoxin (Lanoxin)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase) and zidovudine (Retrovir)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other cancer medicines such as carboplatin, docetaxel (Docefrez, Taxotere), doxorubicin (Doxil), gemcitabine (Gemzar), irinotecan (Camptosar), and paclitaxel (Abraxane, Taxol)
• Rifabutin (Mycobutin) and rifampin (Rifadin)
• St. John's wort
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.