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Sunitinib

(sue-NIT-in-nib)

Trade/other name(s): Sutent, SU11248, sunitinib malate

Why would this drug be used?

This drug is used to treat advanced kidney cancer, gastrointestinal stromal tumor (GIST), and pancreatic neuroendocrine tumors. It is also being studied for use against a number of other cancers.

How does this drug work?

Sunitinib is a type of targeted therapy known as a tyrosine kinase inhibitor. Tyrosine kinases are proteins at the surface of a cell that signal the cell's control center to grow and divide or help form new blood vessels (angiogenesis) to feed the tumor. By blocking these proteins, sunitinib 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. Sunitinib may raise blood pressure. Your doctor will probably want to monitor this closely during treatment.
  • If you have any type of liver disease (including hepatitis). This drug can cause liver damage and even liver failure. Your doctor will check blood tests of liver function before and during treatment with this drug (see “Precautions”).
  • If you have ever been diagnosed with heart disease, including heart attack, congestive heart failure, long Q-T syndrome, heart rhythm problems, or very slow heart rate. Sunitinib may weaken the heart muscle, change its rhythm, and cause other heart problems, especially in people known to have heart disease.
  • If you have thyroid problems or if you’ve taken medicines for your thyroid. This drug could make these worse.
  • If you have any mouth or teeth problems, or if you plan to have dental work in the near future. This drug has been linked to serious damage of the jawbone in some people, especially if they have had recent dental work (see “Precautions”).
  • If you are taking or have taken drugs to strengthen your bones, such as denosumab or drugs called bisphosphonates. You may have a higher risk of jawbone damage if you are on one of these drugs while taking sunitinib (see “Interactions with other drugs”).
  • If you are planning to have an operation or surgical procedure. This drug can cause problems with bleeding and wound healing and so your doctor may want to take you off sunitinib before surgery and for a short time after.
  • If you have any other medical conditions such as kidney disease, bleeding problems, seizures, 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 may harm the fetus if taken at the time of conception or during pregnancy. 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 breastfeeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Breastfeeding is not recommended during treatment with this drug.
  • 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 might help prevent complications if you get sick.

Interactions with other drugs

Sunitinib can interact with a number of drugs and supplements.

The following drugs can cause sunitinib to build up in the body, raising the risk of serious side effects, including heart rhythm problems:

  • The antidepressant nefazodone (Serzone)
  • The antibiotics erythromycin (EES), clarithromycin (Biaxin) and telithromycin (Ketek)
  • Anti-fungals such as ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole (Vfend)
  • HIV drugs such as indinavir, ritonavir, saquinavir, nelfinavir, atazanavir, and others

Do not start or stop taking these medicines while taking sunitinib without talking with the prescribing doctor(s) about all of the medicines you take, including sunitinib.

These drugs and supplements can lower the levels of sunitinib 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)
  • The steroid drug dexamethasone (Decadron)
  • St. John’s wort (herbal dietary supplement)

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

Drugs that affect the heart rhythm such as amiodarone (Cordarone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), mexiletine (Mexitil), moricizine (Ethmozine), procainamide (Procanbid, Pronestyl), propafenone (Rythmol), quinidine (Quinidex), sotalol (Betapace, Betapace AF), and tocainide (Tonocard) may increase the risk of harmful effects on the heart.

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

  • Vitamin E
  • Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others. Check with your pharmacist to see if any of your medicines, including non-prescription drugs, contain any of these.
  • Warfarin (Coumadin)
  • Ticlopidine (Ticlid)
  • Clopidogrel (Plavix)
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Apixaban (Eliquis)
  • Fondaparinux (Arixtra)
  • Any type of heparin including enoxaparin (Lovenox) and dalteparin (Fragmin)

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.

You may have a higher risk of a type of jawbone damage called osteonecrosis of the jaw (see “Precautions” section) if you take certain drugs used to strengthen bones while you are taking sunitinib. Tell your doctor if you are taking or have taken risedronate (Actonel), pamidronate (Aredia), ibandronate (Boniva), etidronate (Didronel), alendronate (Fosamax), tiludronate (Skelid), zoledronic acid (Reclast, Zometa), or denosumab (Xgeva, Prolia).

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

Avoid grapefruit or grapefruit juice, because it may change the level of sunitinib in your blood. Check with your doctor, nurse, or pharmacist about other foods that might cause problems.

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

How is this drug taken or given?

Sunitinib comes in 12.5, 25, 37.5, and 50 mg capsules. Swallow the capsules whole, with or without food. Do not open, split, chew, crush, or melt the capsules. This drug is taken daily, but for some cancers, 4 weeks of treatment is followed by 2 weeks when the drug isn’t taken. This schedule may need to be adjusted if you have side effects. Do not drink grapefruit juice or eat grapefruit until you stop taking the drug entirely.

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 might interact with a number of other drugs or supplements in the body — see “Interactions with other drugs”. 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 the drugs you are taking.

Sunitinib may raise your blood pressure. Tell your doctor if you have ever had high blood pressure or are taking medicines for it. Your blood pressure should be checked regularly during treatment.

Sunitinib may weaken the heart, which in some cases may lead to congestive heart failure. Tell your doctor if you have ever been diagnosed with heart disease. Your doctor may want to test your heart function before you start treatment and again after you have been on this drug for a time. Report any chest pain, extreme tiredness, shortness of breath, or swelling in the hands or feet to your doctor right away.

In rare cases, sunitinib can cause changes in the heart’s rhythm that can even be fatal. This is more common in patients who take drugs that affect the heart’s rhythm, have other heart problems, have a slow heartbeat, long Q-T syndrome, or have abnormal levels of blood electrolytes (like potassium or magnesium). Your doctor may check your EKG and blood tests of electrolytes before you start this drug and again while you are on treatment. Let your doctor know if you have problems with irregular or slow heartbeat, lightheadedness, faintness, or dizziness while on this drug.

This drug may cause liver damage, which may show up as abnormal blood test results. This drug should not be used in patients with known severe liver problems. Your doctor will order blood tests and will check you for signs of liver problems before and during treatment to make sure your liver is working well. Tell your doctor or nurse right away if you have yellowing of the skin or the whites of your eyes (jaundice), dark urine, nausea or vomiting, loss of appetite, pain on the right side of your belly, or any abnormal bruising or bleeding. Your doctor may have to stop treatment with sunitinib if blood tests show signs of liver damage during treatment.

This drug can damage the kidneys and even cause kidney failure. Early signs of kidney damage from this drug include protein in the urine and abnormal blood tests of kidney function. Your doctor will watch these tests while you are on this drug and may need to lower your dose of sunitinib if they become abnormal.

This drug may cause diarrhea. If left unchecked, this could lead to dehydration and chemical imbalances in the body. Your doctor will probably 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. Let your doctor know if the medicine does not control the diarrhea.

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

In rare cases, use of this drug may lead to a serious brain syndrome known as reversible posterior leukoencephalopathy syndrome (RPLS). This can cause seizures, headache, high blood pressure, confusion or change in mental status, and loss of vision. Call your doctor if you have any of these symptoms.

Because this drug interferes with blood vessel formation, it can increase your risk of bleeding. This drug can also lower your platelet count in the weeks after it is given, which would make the risk of bleeding problems higher. Bleeding can be a problem in the brain, bowel, lungs, tumors, wounds, or injuries. Speak with your doctor before taking any drugs or supplements that might affect your body’s ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), heparin, any type of “blood thinner,” or vitamin E (see “Interactions with other drugs”). Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, coughing up blood, or black, tarry stools.

This drug can cause the rapid killing of tumor cells, which in some cases has led to a serious imbalance of electrolytes in the blood, and even kidney damage within the first 3 days of treatment. This condition is known as tumor lysis syndrome. It is more likely to occur if there are large numbers of cancer cells in the body, such as at the beginning of treatment. If your doctor feels you might be at risk, he or she will give you medicines and/or fluids to help prevent it. Let your doctor know right away if you feel weak or faint, have trouble breathing, notice swelling or have other problems after taking this drug.

Sometimes this drug can affect the thyroid gland. Your doctor will check blood tests of thyroid function before treatment. Tell your doctor if you notice tiredness that worsens and doesn’t go away, sweating, intolerance of heat or cold, irregular menstrual periods, weight gain or loss, hair loss, fast heart rate, tremors, or nervousness. Your doctor may do special tests to check on how well the thyroid is working.

This drug can affect the adrenal glands, which might cause your body to not respond physically to stresses such as surgery, trauma, or severe infection. If this occurs, you can have problems such as low blood pressure, diarrhea, vomiting, and passing out (loss of consciousness). You may need to be treated with cortisol-like drugs to prevent more serious problems.

This drug can lower your white blood cell count, which can last for 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, abdominal pain, reddened skin, tenderness, swelling or pus, a new cough, or bringing up sputum.

Do not get any immunizations (vaccines), either during or for some time after treatment with this drug, without your doctor’s OK. Sunitinib may affect your immune system. This could make vaccinations ineffective, or even lead to serious infections if you get 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.

This drug can cause problems with wound healing and should be stopped for a time before any planned surgery. Be sure to discuss this with your doctor before any planned surgery, including dental procedures.

In rare cases, this drug can cause serious jawbone damage, a condition called osteonecrosis of the jaw (ONJ). The risk of this is higher if you have taken another drug that can lead to ONJ. Most cases have been in people who had certain dental procedures recently such as having a tooth pulled while taking the drug. Your doctor may recommend a thorough dental exam before you start this drug. Tell your dentist that you are on this drug and talk with him or her about the best ways to prevent problems. While you are getting treatment, take good care of your teeth, and check with your doctor before having any dental procedures done. Tell your doctor if you notice loose teeth, swollen gums, or pain or numbness in your jaw.

This drug can rarely cause severe skin problems which can even be fatal. Let your doctor know if you develop a rash with blisters, skin peeling, or sores in your mouth, especially if it gets worse over time.

Your doctor will likely test your blood throughout your treatment, looking for 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 completely. Be sure to keep all your appointments for lab tests and doctor visits.

This drug may harm the fetus and so you should avoid pregnancy during and for some time after taking this drug. Women who can become pregnant should use effective birth control during treatment. 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

  • Low white blood cell count (with increased risk of infection)*
  • Diarrhea*
  • Upset stomach, indigestion, or heartburn
  • Nausea/vomiting
  • Mouth sores, pain, or burning
  • Changes in the way food tastes
  • Loss of appetite
  • Feeling tired or weak
  • Change in the color of the skin
  • Hair color changes
  • Constipation
  • High-blood pressure*

Less common

  • Bleeding, including nosebleeds, bleeding in the brain, bowel, and other sites*
  • Redness, pain, swelling, or blisters on hands or feet (hand-foot syndrome)*
  • Low blood platelet count with increased risk for bleeding*
  • Rash
  • Dry, cracking skin
  • Altered taste
  • Joint pain
  • Abdominal pain
  • Back pain
  • Pain in the arms and legs
  • Shortness of breath
  • Cough
  • Feeling weak
  • Dizziness
  • Headache
  • Fever
  • Swelling in the hands or feet*
  • Trouble sleeping
  • Abnormal blood tests suggesting drug may be affecting the liver, kidneys, or pancreas (Your doctor will discuss the importance of this finding, if any.)*

Rare

  • Hair loss
  • Heart attacks*
  • Liver failure*
  • Kidney failure*
  • Congestive heart failure with symptoms like rapid weight gain, trouble breathing, and swelling of hands or feet, which may get better after the drug is stopped*
  • Major blood clots (in the legs, lungs, or brain)
  • Low thyroid function (hypothyroidism) or high thyroid levels (hyperthyroidism)*
  • Suppressed adrenal gland function, which can lead to problems physically responding to stress*
  • Problems and delays in wound healing*
  • Brain syndrome (reversible posterior leukoencephalopathy syndrome) causing seizures, confusion, changes in mental status, and vision loss*
  • Damage to the jawbone (osteonecrosis of the jaw)*
  • Tumor lysis syndrome with chemical imbalances and possible kidney failure*
  • Severe skin reactions*
  • Severe allergic reaction with symptoms like itching, hives, swelling in the mouth or throat, trouble breathing or swallowing, and shock
  • Serious infections of the lungs, kidneys, bladder, blood, skin, or other sites
  • Gallbladder disease (cholecystitis)
  • Death due to problems such as heart failure, bleeding, infection, liver damage, blood clots in the lung, stroke, holes in the intestines, kidney failure, or other causes

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

There are other side effects not listed above that 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 2006.

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: 08/22/2014
Last Revised: 08/22/2014