Sunitinib Malate (soo-NI-ti-nib MAL-ate)
Treats late-stage kidney cancer and gastrointestinal stromal tumor (GIST). Also used to treat locally advanced or metastatic pancreatic cancer called pancreatic neuroendocrine tumor (pNET).
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
Do not use this medicine if you have had an allergic reaction to sunitinib, 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, chew, or open it.
- 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 dexamethasone (Decadron®), nefazodone (Serzone®), medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Reyataz®, or Viracept®), medicine to treat an infection (such as clarithromycin, rifabutin, rifampin, rifapentine, telithromycin, Biaxin®, Ketek®, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Carbatrol®, Dilantin®, Luminal®, or Tegretol®), 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®) or bone problems (such as alendronate, ibandronate, risedronate, Actonel®, Boniva®, Fosamax®, or Zometa®).
- Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Warnings While Using This Medicine
- Your unborn baby could be harmed if you use this medicine while you are pregnant. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant while using the medicine.
- If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment.
- Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, heart disease, congestive heart failure, dental problems, heart rhythm problems (such as QT prolongation), high blood pressure, thyroid problems, or any bleeding problems. 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, wrists, ankles, or feet. These may be symptoms of a heart problem.
- This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
- This medicine may also increase your risk of bleeding and delay wound healing. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Check with your doctor before you have any dental procedures or surgeries, and tell him if you have ever received medicines called bisphosphonates. Tell your doctor right away if you have jaw tightness, swelling, numbing, pain, or a loose tooth. These could be symptoms of a severe jaw problem.
- This medicine may cause a serious reaction called tumor lysis syndrome. Call your doctor right away if you have changes in how often you urinate, rapid weight gain, swelling of the feet or lower legs, uneven heartbeat, or seizures.
- Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
- 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.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
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
- Blisters or rash on the palms of your hands or soles of your feet
- Bloody vomit or black, tarry stools, nosebleeds, or other unusual bleeding or bruising
- Chest pain or discomfort, shortness of breath, or coughing up blood
- Confusion, dizziness, lightheadedness, or fainting
- Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow eyes or skin
- Decrease in how much or how often you urinate
- Dry mouth, increased thirst, or muscle cramps
- Fast, slow, or pounding heartbeat
- Fever, chills, cough, sore throat, and body aches
- Jaw tightness, swelling, numbing, or pain or a loose tooth
- 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, swelling in your hands, ankles, or feet
- Sores or white patches on your lips, mouth, or throat
- Sudden or severe headache, or problems with vision, speech, or walking
If you notice these less serious side effects, talk with your doctor:
- Changes in hair color, loss of hair
- Diarrhea, constipation, mild nausea or vomiting, gas, or stomach pain
- Dry skin, blisters, or skin rash or discoloration
- Tiredness or weakness
- Unusual taste in your mouth, loss of appetite
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
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