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Warnings and Precautions With Sunitinib

Specific Sunitinib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Sunitinib can cause serious liver problems that could lead to liver failure or death. Your healthcare provider will monitor your liver function with blood tests before you start taking it and periodically thereafter. If you begin to develop liver problems, your healthcare provider may recommend you stop taking this medication. Contact your healthcare provider right away if you experience signs of liver disease, such as:
    • Fatigue or extreme tiredness
    • Dark urine
    • Loss of appetite
    • Pain in the right upper part of the stomach
    • Yellowing of the skin or whites of the eyes (jaundice).
  • There have been reports of heart problems, including heart failure, in people taking sunitinib. Your healthcare provider may decrease your daily dose, or stop treatment altogether, if you begin to show evidence of heart failure while taking this medicine.
  • Sunitinib may cause a potentially dangerous change in the heart rhythm known as QT prolongation. This problem may be more common in people who have heart rhythm problems or who are taking certain other medications (see Drug Interactions With Sunitinib). Your healthcare provider will monitor your heart rhythm with an electrocardiogram (ECG) before you start the drug and throughout treatment.
  • This medication has been reported to cause life-threatening bleeding, including bleeding of the stomach, intestines, and brain. It has also been reported to cause tears or holes in the stomach and intestines. Let your healthcare provider know if you develop any signs of bleeding, such as:
    • Unusual bruising
    • Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
    • Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
  • Sunitinib has been reported to cause heart attack and stroke. You may be at higher risk for these serious side effects if you have ever had a heart attack or stroke. Seek immediate medical attention if you experience any of the following symptoms, which could be signs of a serious problem:
    • Chest pain or pressure in your chest
    • Shortness of breath or difficulty breathing
    • Pain in the arm, back, neck, or jaw
    • Numbness or weakness on one side of the body
    • Difficulty walking or talking.
  • Sunitinib may cause high blood pressure (hypertension). Your healthcare provider will monitor you for this side effect during treatment. If your blood pressure increases too much, you may need to take high blood pressure medication.
  • This drug may affect the ability of wounds or sores to heal. For this reason, it is generally recommended that sunitinib treatment be temporarily stopped before any major surgery. Contact your healthcare provider right away if you have wounds that are red, oozing, or do not seem to be healing. Also, tell your healthcare provider if you have plans for surgery.
  • This medication may cause an underactive or overactive thyroid (known medically as hypothyroidism and hyperthyroidism, respectively). Your healthcare provider will monitor your thyroid function with a blood test before you start sunitinib and observe you closely for thyroid problems during treatment.
  • Your body may not respond as well to situations that put it at stress, such as surgery or severe infection, while you are taking this medicine. Your healthcare provider will need to monitor you more closely during these periods.
  • You will need blood tests before you start sunitinib, and routinely during treatment. Therefore, it is important to keep all your healthcare provider and laboratory appointments while taking this medication.
  • Talk to your healthcare provider before getting any type of vaccination or immunization during sunitinib treatment. Vaccinations may be less effective. You could also become infected with the bacteria or viruses used to make "live" vaccines (see Drug Interactions With Sunitinib).
  • Sunitinib can react with a number of other medications (see Drug Interactions With Sunitinib).
  • This product is considered a pregnancy Category D medication, which means it may harm an unborn child. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant (see SUTENT and Pregnancy).
  • It is unknown if sunitinib passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see SUTENT and Breastfeeding).
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