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Sorafenib

(so-raf-uh-nib)

Trade/other name(s): Nexavar, BAY 43-9006, sorafenib tosylate

Why would this drug be used?

This drug is used to treat advanced cancers of the kidney, liver, or thyroid. It is also being studied for use against a number of other cancers and non-cancerous conditions.

How does this drug work?

Sorafenib is a type of targeted therapy known as a kinase inhibitor. Kinases are proteins on or near the surface of a cell that transmit important signals to the cell’s control center. Sorafenib blocks several kinase proteins that either prompt tumor cells to grow or help form new blood vessels (angiogenesis) to feed the tumor. By blocking these proteins, sorafenib can help stop the growth of cancer cells.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have high blood pressure. Sorafenib may raise blood pressure. Your doctor will likely want to monitor this closely during treatment.
  • If you have any type of liver disease (including hepatitis). This drug is cleared from the body mainly by the liver. Reduced liver function might result in more drug than expected staying in the body, which could lead to unwanted side effects. Your doctor may need to adjust your dose.
  • If you have had a recent heart attack or have been diagnosed with heart disease. Sorafenib may raise the risk of heart problems, especially in people with heart disease.
  • If you have long Q-T interval or irregular heart rhythm. This drug can make it worse.
  • If you have any other medical conditions such as bleeding problems, kidney disease, congestive heart failure, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug can cause problems with the fetus if taken at the time of conception or during pregnancy. Men and women who are taking this drug should use some kind of birth control during and for at least 2 weeks after finishing treatment. Check with your doctor about what kinds of birth control can be used with this medicine. In pregnant women, treatment with this drug should be used only if the potential benefit to the mother outweighs the risk to the fetus.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • If you have any surgery or procedures planned.
  • If you think you might want to have children in the future. This drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Sorafenib may interact with a number of drugs and supplements, which may either raise or lower the level of sorafenib in your blood. The following drugs and supplements can lower the levels of sorafenib in the blood and make it less effective:

  • Anti-seizure drugs carbamazepine (Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin)
  • TB drugs rifampin (Rifadin, Rimactane; also in Rifamate and Rifater), rifapentin (Priftin), and rifabutin (Mycobutin)
  • Dexamethasone (Decadron), a steroid drug
  • St. John’s wort (herbal dietary supplement)

If you need to take these drugs, your doctor may need to adjust your dose of sorafenib.

Sorafenib may alter blood levels of some chemotherapy drugs, including:

  • Irinotecan
  • Fluorouracil
  • Docetaxel
  • Doxorubicin

The following drugs may build up in the body if they are taken with sorafenib, so that you may have an increased effect of the drug and worse side effects:

  • Methadone (Dolophine, Methadose), an opioid pain medicine
  • Bupropion (Wellbutrin), an antidepressant
  • Cancer treatment drugs cyclophosphamide (Cytoxan), ifosfamide (Ifex), paclitaxel (Abraxane),
  • Torsemide (Demadex), a diuretic or “water pill”
  • Efavirenz (Sustiva), an HIV treatment drug
  • Repaglinide (Prandin), used for diabetes

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with sorafenib. These include things like:

  • Vitamin E
  • Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • Warfarin (Coumadin)
  • Ticlopidine (Ticlid)
  • Clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

Other drugs that affect the heart’s rhythm or electrical system, such as amiodorone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Rhythmol), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Tambocor), quinidine (Quinidex, Cardioquin), or sotalol (Betapace) can worsen the effects of this drug on the heart.

This drug should not be used along with carboplatin and paclitaxel in people with squamous cell lung cancer (a type of non-small cell lung cancer).

Other medicines or supplements may affect blood levels of sorafenib, or levels of these drugs may be affected by taking sorafenib. Make sure your doctor is aware of all drugs and supplements you are taking.

Check with your doctor, nurse, or pharmacist about any other medicines, herbs, and supplements you are taking, and whether alcohol can cause problems with this medicine.

Interactions with foods

Food can reduce the amount of sorafenib that absorbs into your body. Take this drug on an empty stomach. Check with your doctor, nurse, or pharmacist about whether other foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Sorafenib comes in 200 mg tablets. It should be taken with water on an empty stomach (at least 1 hour before or 2 hours after a meal). The recommended starting dose is 400 mg (2 tablets) twice a day. This schedule may need to be adjusted if you have side effects.

Take this drug exactly as directed by your doctor. If you do not understand the instructions, ask your doctor or nurse to explain them to you. Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets.

Precautions

This drug may interact with a number of other drugs or supplements in the body. (See “Interactions” above.) Be sure your doctor is aware of all drugs and supplements you are taking. Do not start or stop taking any drug without talking to your doctor about all of them.

Sorafenib may raise your blood pressure. Tell your doctor if you have ever had high blood pressure or are taking medication for it. Your blood pressure should be checked regularly, especially during the first 6 weeks of treatment.

This drug may cause diarrhea. If left unchecked, this could lead to dehydration and chemical imbalances in the body. Your doctor will likely prescribe medicine to help prevent or control this side effect. It is very important that you take this medicine as prescribed. Make sure you get the medicine right away, so that you will have it at home when you need it. Tell your doctor if the medicine does not control the diarrhea.

This drug can cause a condition known as hand-foot syndrome, in which a person may experience pain, numbness, tingling, redness, or swelling in the hands or feet. Peeling, blistering, or sores on the skin in these areas are also possible. Let your doctor know right away if you notice any of these symptoms.

Your doctor will likely test your blood throughout your treatment, looking for possible effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Be sure to keep all your appointments for lab tests and doctor visits.

This drug may increase the risk of bleeding. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, blood in your urine, or black, tarry stools.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, new onset of cough, or bringing up sputum.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. Sorafenib may affect your immune system. This could make vaccines ineffective, or even lead to serious infections if you take a live virus vaccine during or soon after treatment. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

Rarely, sorafenib can cause holes (perforations) in the digestive tract, which can be life-threatening. Tell your doctor or nurse right away if you have any severe stomach (abdominal) pain, especially if you also have nausea, vomiting, constipation, fever, or any other symptom.

This drug may affect the rhythm or function of the heart, and has been linked to heart attacks. Tell your doctor if you have had any heart problems before starting treatment. Possible symptoms of heart problems might include pounding heart, fast or irregular heartbeat, dizziness or fainting, lightheadedness, chest pain, increased coughing, trouble breathing (especially at night), sweating a lot, or swelling in the ankles or legs. A very slow heartbeat can also happen. Tell your doctor right away if you notice any of these symptoms once treatment begins.

This drug can cause changes in thyroid hormone levels. If you have thyroid cancer, your doctor might need to increase your dose of thyroid medicine while you are taking this drug. Your doctor should check your thyroid hormone levels every month during treatment with this drug.

This drug can cause severe liver damage in a few people. Your doctor will check your blood so that if this starts, it can be found early. Call your doctor right away if you notice nausea, vomiting, fatigue, poor appetite, dark urine, yellowing skin or eyes, or tenderness under the right side of the rib cage.

Tell your doctor or dentist if you have surgery planned. This drug can keep wounds from healing as they should. Your doctor may want to stop this medicine for some time before surgery.

Avoid pregnancy while taking this drug and for at least 2 weeks afterward. It may harm the fetus. Men should also use effective birth control during treatment and for 2 weeks afterward. Talk with your doctor about this.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Diarrhea*
  • Feeling tired
  • Rash, redness, or peeling skin
  • Itching
  • Redness, pain, swelling, or blisters on hands or feet (hand-foot syndrome)*
  • Change in thyroid hormone levels*

Less common

  • High blood pressure*
  • Bleeding*
  • Nausea/vomiting
  • Hoarseness
  • Constipation
  • Loss of appetite
  • Dry skin
  • Hair loss or thinning (may include face and body hair)
  • Numbness and tingling in hands and/or feet*
  • Headache
  • Joint pain
  • Abdominal pain
  • Weight loss
  • Abnormal levels of minerals or pancreas enzymes on blood tests (Your doctor will discuss the importance of this finding, if any.)

Rare

  • Heart attacks*
  • Flushing
  • Mouth sores
  • Fever
  • Low white blood cell count (with increased risk of infection) *
  • Depression
  • Bone or muscle pain
  • Holes in the intestine*
  • Liver damage*
  • Low blood calcium levels (Your doctor will discuss the importance of this finding, if any.)
  • Muscle damage, with pain, stiffness, tenderness, or weakness of the muscles
  • Allergic reaction
  • Severe skin rash with redness and blistering
  • Allergic reaction with trouble breathing, swelling in mouth or throat, dizziness, shock
  • Erectile dysfunction (impotence)
  • Death due to bleeding, infection, liver failure, or other cause

*See the “Precautions” section for more detailed information.

Other side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2005

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 09/26/2012
Last Revised: 11/25/2013