sunitinib

What is the most important information I should know about sunitinib?

What is sunitinib?

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.

What should I discuss with my healthcare provider before using sunitinib?

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.

• 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.

This medicine 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.

How should I take sunitinib?

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.

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 before and after major surgery.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking sunitinib?

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

What are the possible side effects of sunitinib?

• 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 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.

What other drugs will affect sunitinib?

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 affect sunitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about sunitinib.