sunitinib (Sutent)

Brand Names: Sutent

Generic Name: sunitinib

• What is sunitinib (Sutent)?
• What are the possible side effects of sunitinib (Sutent)?
• What is the most important information I should know about sunitinib (Sutent)?
• What should I discuss with my healthcare provider before using sunitinib (Sutent)?
• How should I take sunitinib (Sutent)?
• What happens if I miss a dose (Sutent)?
• What happens if I overdose (Sutent)?
• What should I avoid while taking sunitinib (Sutent)?
• What other drugs will affect sunitinib (Sutent)?
• Where can I get more information (Sutent)?

Sunitinib is used to treat certain types of advanced or progressive tumors of the stomach, intestines, esophagus, pancreas, or kidneys.

Sunitinib may also be used for purposes not listed in this medication guide.

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capsule, orange, imprinted with Pfizer, STN 12.5 mg

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capsule, brown/orange, imprinted with Pfizer, STN 25 mg

000690980_PB

capsule, brown, imprinted with Pfizer, STN 50 mg

Get emergency medical help if you have signs of an allergic reaction (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).

Also call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• pain, redness, numbness, and peeling skin on your hands or feet;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, dizziness;
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or 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--muscle cramps, tiredness, confusion, fast or slow heart rate, vomiting, diarrhea, decreased urination, tingling in your hands or feet, tingling 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 side effects may include:

• indigestion, decreased appetite, stomach pain, nausea, vomiting, diarrhea;
• feeling weak or tired;
• blisters or ulcers in your mouth, red or swollen gums, altered sense of taste, trouble swallowing;
• blisters or rash on your hands or feet;
• increased blood pressure;
• bruising or bleeding; or
• skin rash or dryness, changes in skin or hair color.

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.

Sunitinib 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).

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

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;
• a seizure;
• a bleeding or blood-clotting disorder;
• a thyroid disorder; or
• long QT syndrome (in you or a family member).

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 sunitinib 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 sunitinib.

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

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

Sunitinib is usually taken once per day. Sunitinib 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 sunitinib with or without food.

Do not crush, chew, or open a sunitinib 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 sunitinib. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

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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.

Tell your doctor about all your other medicines, especially:

• osteoporosis medicine.

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.

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

Your pharmacist can provide more information about sunitinib.

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