Sunitinib

Pronunciation: soo-NI-ti-nib
Generic Name: Sunitinib
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 or bowel 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 blocking certain enzymes in the body that may be involved in the growth and spread of cancer cells. This helps to slow tumor growth and may decrease the ability of the cancer to spread to other areas of the body.

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 bevacizumab, halofantrine, St. John's wort, toremifene, or vandetanib

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

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 disease 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, or a seizure disorder (eg, epilepsy)


• if you have a severe infection, have recently been injured, or will be having surgery

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

• Antiarrhythmics (eg, amiodarone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, tacrolimus, terfenadine, toremifene, tricyclic antidepressants (eg, amitriptyline), vandetanib, or ziprasidone because the risk of serious irregular heartbeat may be increased


• Bevacizumab because a certain type of severe anemia (eg, hemolytic anemia) may occur


• HIV protease inhibitors (eg, indinavir, ritonavir), imidazole antifungals (eg, itraconazole, ketoconazole, voriconazole), macrolide antibiotics (eg, clarithromycin), nefazodone, telithromycin, or temsirolimus because they may increase the risk of Sunitinib's side effects


• Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), nevirapine, rifamycins (eg, rifampin), or St. John's wort because they may decrease Sunitinib's effectiveness

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 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.


• 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 discomfort; back pain; changes in taste; constipation; diarrhea; dizziness; dry, thick, or cracked skin; headache; indigestion; mild loss of appetite or stomach pain; mouth or tongue pain, 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); black, tarry, or bloody stools; blistering or rash on the palms of hands and soles of feet; bloody urine; calf or leg pain, redness, swelling, or tenderness; chest pain; coughing up blood; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; mental or mood changes (eg, decreased alertness, depression, irritability, nervousness); muscle pain, tenderness, or weakness; numbness of an arm or leg; numbness or tingling of the hands or feet; seizures; severe or persistent headache, dizziness, stomach pain, back pain, tiredness, or weakness; shortness of breath; swelling of the hands, ankles, feet, or legs; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision problems); symptoms of thyroid problems (eg, changes in menstrual period, excessive sweating, hair loss, increased appetite, increased sensitivity to hot or cold conditions, sudden weight changes, tremors, 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.

See also: Sunitinib side effects (in more detail)

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 is a summary only. It does not contain all information about Sunitinib. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Sunitinib resources

• Sunitinib Side Effects (in more detail)
• Sunitinib Use in Pregnancy & Breastfeeding
• Sunitinib Drug Interactions
• Sunitinib Support Group
• 7 Reviews for Sunitinib - Add your own review/rating

• Sunitinib Malate Monograph (AHFS DI)


• Sutent Prescribing Information (FDA)


• sunitinib Concise Consumer Information (Cerner Multum)


• sunitinib Advanced Consumer (Micromedex) - Includes Dosage Information

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