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Sunitinib

Generic Name: sunitinib (soo-NI-ti-nib)
Brand Name: Sutent

Severe and sometimes fatal liver problems have occurred in patients who take sunitinib. Contact your doctor immediately if you experience symptoms of liver problems, including dark urine, itching, loss of appetite, nausea, pale stools, stomach pain, unusual tiredness, or yellowing of the eyes or skin.


Sunitinib is used for:

Treating a certain type of stomach, bowel, or esophagus tumor in certain patients. It is also used to treat certain types of kidney or pancreatic cancer. It may also be used for other conditions as determined by your doctor.

Sunitinib is a multikinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use sunitinib if:

  • you are allergic to any ingredient in sunitinib
  • you have a history of abnormal liver function tests or liver problems caused by sunitinib
  • you are taking asenapine, bevacizumab, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

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Before using sunitinib:

Some medical conditions may interact with sunitinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, liver problems, or muscle problems
  • if you have a history of congestive heart failure, angina, irregular heartbeat (eg, QT prolongation), slow heartbeat, or other heart problems; a recent heart attack, stroke, or transient ischemic attack (TIA) (mini-stroke); a blood clot in the lung (pulmonary embolism); blood vessel problems or certain blood vessel surgery (coronary or peripheral artery bypass graft); or if you are at risk of heart problems
  • if you have bleeding problems, high blood pressure, blood electrolyte problems (eg, low blood magnesium or potassium levels), adrenal gland problems, thyroid problems, poor dental hygiene or other dental problems, or a seizure disorder (eg, epilepsy)
  • if you have or have had pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw; or loosening of a tooth
  • if you have a severe infection, have recently been injured, or will be having surgery
  • if you are on dialysis
  • if you are taking a bisphosphonate (eg, alendronate, risedronate) or if you have taken one in the past

Some MEDICINES MAY INTERACT with sunitinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for aches and pains, cancer, depression or other mental or mood problems, heartburn, hepatitis C infection, HIV infection, immune system suppression, infections, inflammation or swelling, irregular heartbeat or other heart problems, narcotic addiction, nausea and vomiting, seizures, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with sunitinib. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with sunitinib

This may not be a complete list of all interactions that may occur. Ask your health care provider if sunitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use sunitinib:

Use sunitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sunitinib comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get sunitinib refilled.
  • Take sunitinib by mouth with or without food.
  • Swallow sunitinib whole. Do not open the capsules. Do not break, crush, or chew before swallowing.
  • Do not eat grapefruit or drink grapefruit juice while you take sunitinib.
  • If you miss a dose of sunitinib, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Tell your health care provider about any missed dose.

Ask your health care provider any questions you may have about how to use sunitinib.

Important safety information:

  • Sunitinib may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use sunitinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Sunitinib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Sunitinib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Contact your doctor if you have a wound that does not heal properly while you are taking sunitinib.
  • Diarrhea, nausea, stomach upset, and vomiting are common with sunitinib. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
  • Certain jawbone problems have been reported in patients taking sunitinib. The risk may be greater in patients who have poor dental hygiene or other dental problems, or in those who are taking bisphosphonates (eg, alendronate). Talk to your doctor about having a dental exam before you start to take sunitinib. Ask your doctor any questions you may have about dental treatment while you take sunitinib.
  • A serious and possibly fatal condition called tumor lysis syndrome (TLS) has occurred in certain patients taking sunitinib. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
  • Proper dental care is important while you are taking sunitinib. Brush and floss your teeth and visit the dentist regularly.
  • Certain patients taking sunitinib should avoid certain dental procedures if possible. Tell your doctor or dentist that you take sunitinib before you receive any medical or dental care, emergency care, or surgery.
  • Skin or hair discoloration may occur while you are taking sunitinib. Contact your doctor with any questions or concerns.
  • Women who may become pregnant should use an effective form of birth control while they take sunitinib. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including complete blood cell counts, blood electrolytes, blood pressure checks, thyroid function, liver function, and electrocardiograms (ECG) and other heart function tests (echocardiograms), may be performed while you take sunitinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sunitinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Sunitinib may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking sunitinib while you are pregnant. It is not known if sunitinib is found in breast milk. Do not breast-feed while taking sunitinib.

Possible side effects of sunitinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Arm or leg pain; back or joint pain; changes in taste; constipation; diarrhea; dizziness; dry, thick, or cracked skin; headache; indigestion; mild loss of appetite or stomach pain; mouth or tongue swelling, soreness, or irritation; nausea; skin or hair discoloration; stomach upset; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); arm, calf, or leg pain, redness, swelling, or tenderness; black, tarry, or bloody stools; blistering or rash on the palms of the hands and soles of the feet; bloody urine; chest or left arm pain; confusion; coughing up blood; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; mental or mood changes (eg, decreased alertness, depression, irritability); muscle pain, tenderness, or weakness; numbness or tingling of the hands or feet; 1-sided weakness; seizures; severe or persistent headache, dizziness, diarrhea, back pain, tiredness, or weakness; severe stomach pain or swelling; shortness of breath; slurred speech; sudden, severe nausea or vomiting; swelling of the hands, ankles, feet, or legs; swelling or pain in the jaw; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); symptoms of thyroid and adrenal gland problems (eg, agitation; appetite changes; changes in menstrual period; excessive sweating; hair loss; increased sensitivity to hot or cold conditions; nervousness; sudden, unusual weight changes; tremors; unusual nausea, vomiting, or diarrhea; worsening tiredness); unusual or severe bruising or bleeding (eg, bleeding gums, nosebleeds); vision changes or vision loss; vomiting blood or vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of sunitinib:

Store sunitinib at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep sunitinib out of the reach of children and away from pets.

General information:

  • If you have any questions about sunitinib, please talk with your doctor, pharmacist, or other health care provider.
  • Sunitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sunitinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sunitinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sunitinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sunitinib.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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