Sutent is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Sutent is a prescription medicine used to treat certain types of advanced or progressive tumors of the stomach, intestines, esophagus, pancreas, or kidneys.

It is not known if Sutent is safe and effective in children.

Sutent can cause severe or fatal effects on your liver. You will need frequent blood tests to check your liver function during treatment. Call your doctor if you have any signs of a liver problem, such as right-sided upper stomach pain, itching, dark urine, or jaundice (yellowing of the skin or eyes).

Take Sutent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your blood pressure and liver function may need to be tested at the beginning of each 4-week treatment cycle.

Sutent is usually taken once per day. Sutent is sometimes taken for 4 weeks followed by 2 weeks off the drug. Your doctor will determine how many complete treatment cycles you need based on your condition.

You may take Sutent with or without food.

Do not crush, chew, or open a Sutent capsule. Swallow it whole. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

You will need frequent blood and urine tests. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis, and you may also need frequent dental exams.

If you need surgery or a dental procedure, tell the surgeon or dentist you currently use Sutent. You may need to stop using the medicine for a short time before and after major surgery.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:
-For the treatment of advanced renal cell carcinoma (RCC)
-For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:
-For the treatment of advanced renal cell carcinoma (RCC)
-For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Pancreatic Cancer:

37.5 mg orally once daily

Comments:
-To be taken continuously without a scheduled off-treatment period; may be taken with or without food.

Use: For the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

You should not use Sutent if you are allergic to sunitinib.

To make sure Sutent is safe for you, tell your doctor if you have ever had:

• kidney problems other than cancer;

• liver disease;

• heart disease, high blood pressure;

• low blood sugar, or diabetes;

• bleeding problems;

• long QT syndrome (in you or a family member);

• a thyroid disorder; or

• surgery (or if you plan to have surgery).

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

Sunitinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Sutent if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 weeks after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 7 weeks after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Sutent.

Sunitinib may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because sunitinib can harm an unborn baby.

You should not breastfeed while you are using Sutent and for at least 4 weeks after your last dose.

Sutent is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with sunitinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Sunitinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Sutent (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Sunitinib can cause severe or fatal effects on your liver. Call your doctor if you have loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Sutent may also cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Also call your doctor at once if you have:

• pain, redness, numbness, and peeling skin on your hands or feet;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• painful skin sores, sores in your mouth or on your lips;

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;

• confusion, thinking problems, vision loss, seizure;

• heart problems - swelling, rapid weight gain, fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, dizziness;

• low blood sugar - headache, hunger, weakness, sweating, fast heart rate, feeling jittery;

• signs of bleeding inside your body - change in your mental state, blood in your urine, pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth; or

• symptoms of a thyroid problem - severe and worsening tiredness, depression, fast heart rate, agitation, tremors, feeling nervous, sweating, nausea, vomiting, diarrhea, hair loss, weight changes, irregular menstrual periods.

Common Sutent side effects may include:

• indigestion, decreased appetite, stomach pain, nausea, vomiting, diarrhea;

• feeling weak or tired;

• mouth sores or pain, altered sense of taste;

• blisters or rash on your hands or feet;

• bruising or bleeding; or

• increased blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sutent can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• osteoporosis medicine.

This list is not complete. Other drugs may interact with sunitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.