Treats late-stage kidney cancer and gastrointestinal stromal tumor in patients who have taken imatinib mesylate.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to sunitinib malate, or if you are pregnant.
How to Use This Medicine
- Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- Swallow the capsule whole. Do not crush, break, or chew it.
- You may take this medicine with or without food.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
If a dose is missed:
- This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using atazanavir (Reyataz®), carbamazepine (Carbatrol®, Tegretol®), clarithromycin (Biaxin®), dexamethasone (Decadron®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone (Serzone®), nelfinavir (Viracept®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), rifapentin (Priftin®), ritonavir (Norvir®), saquinavir (Fortovase®, Invirase®), telithromycin (Ketek®), voriconazole (Vfend®), or St. John's Wort.
- Tell your doctor if you are also using medicines for heart rhythm problems such as amiodarone, bepridil, digoxin, flecainide, lidocaine, propafenone, quinidine, Cardioquin®, Cordarone®, Lanoxin®, or Tambocor®.
- Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
- Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
Warnings While Using This Medicine
- Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
- If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib malate therapy.
- Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems (such as QT prolongation), high blood pressure, seizures, thyroid problems, nosebleeds, stomach ulcers, or any other bleeding. Tell your doctor if you have recently had any surgery, trauma, or severe infection.
- Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
- Check with your doctor right away if you are rapidly gaining weight or have shortness of breath; chest pain or discomfort; extreme tiredness or weakness; irregular breathing; uneven heartbeats; or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
- Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
- This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Burning sensation on the tongue.
- Chest pain or discomfort, shortness of breath, or coughing up blood.
- Confusion, dizziness, lightheadedness, or fainting.
- Decrease in how much or how often you urinate.
- Dry mouth, increased thirst, or muscle cramps.
- Fast, slow, or pounding heartbeat.
- Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
- Muscle pain, tenderness, or weakness.
- Numbness or weakness in your arm or leg, or on one side of your body.
- Pain in your lower leg (calf).
- Rapid weight gain.
- Sores or white patches on your lips, mouth, or throat.
- Sudden and severe stomach pain, nausea, or vomiting.
- Sudden or severe headache, or problems with vision, speech, or walking.
- Swelling in your hands, ankles, or feet.
- Tingling or numbness on your hands, feet, or lips.
- Trouble breathing.
- Unusual bleeding or bruising.
- Watery eyes, or pain or swelling around the eyes.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Changes in hair color, or loss of hair.
- Depression, trouble sleeping.
- Diarrhea, constipation, mild nausea or vomiting, gas, stomach pain, or upset stomach.
- Dry skin, blisters, or skin rash or discoloration.
- Muscle, joint, or back pain.
- Tiredness or weakness.
- Unusual taste in your mouth, or loss of appetite.
- Weight loss.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04