Votrient Warnings and Precautions

Specific Precautions and Warnings With Votrient

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Votrient can cause potentially life-threatening liver problems. Your healthcare provider will monitor your liver function with blood tests before you start Votrient, every month for the first four months, and then periodically throughout the remainder of treatment. 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 problems, such as:
 
    • Fatigue or excessive tiredness
    • Dark urine
    • Loss of appetite
    • Pain in the upper-right area of the abdomen (stomach)
    • Yellowing of the skin or whites of the eyes (jaundice).
 
  • People with moderate liver disease (moderate hepatic impairment) will need lower Votrient doses. This medication has not been studied in people with severe liver disease.
 
  • Votrient may cause potentially dangerous heart rhythm problems, including a problem known as QT prolongation. People who have had heart rhythm problems in the past or those who take certain medications may have a higher risk for this side effect (see Votrient Drug Interactions). Your healthcare provider will monitor your heart rhythm with an electrocardiogram (ECG) before you start this medicine and periodically during treatment.
     
  • Votrient can also cause a dangerously slow heart rate (bradycardia). Your healthcare provider should monitor you for this problem.
 
  • This medication has been reported to cause life-threatening bleeding, including bleeding of the stomach and intestines. 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 a bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
 
  • Votrient has been reported to cause heart attacks and strokes. You may have a higher risk for these serious side effects if you have a history of heart attack or stroke. Seek immediate medical attention if you experience any of the following symptoms:
 
    • 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.
 
  • People who take this medication may develop hypertension (high blood pressure) that requires treatment. If your blood pressure remains high despite treatment, your healthcare provider may need to reduce your Votrient dosage or stop treatment with it. A sudden, extreme increase in blood pressure can be life-threatening. Signs of dangerously high blood pressure include blurred vision, severe headache, confusion, and nausea and vomiting. The medication may also cause heart problems such as congestive heart failure.
 
  • Votrient may affect the ability of wounds or sores to heal. 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 while taking this drug.
 
  • This medication may cause hypothyroidism, which is when the body does not make enough thyroid hormone. Your healthcare provider will monitor you for this side effect throughout treatment.
 
  • You may develop a condition known as proteinuria while taking Votrient, which is when the urine contains an abnormal amount of protein. You will have urine tests to monitor for this side effect. Contact your healthcare provider if your urine appears foamy, or if you experience swelling in your hands, feet, or face.

 

  • People who take this medicine may develop life-threatening blood clots in the blood vessels of their legs or lungs. Seek immediate medical attention if you develop signs of a blood clot, such as sudden shortness of breath, chest pain, or pain or swelling in one or both arms or legs.
     
  • Votrient has been associated with a serious condition known as reversible posterior leukoencephalopathy (RPLS). RPLS can cause death. Seek immediate medical help if you experience signs of this condition, including headache, seizure, lack of energy, confusion, difficulty thinking, high blood pressure, and loss of vision or other vision changes.
 
  • There have been a few reports of a serious condition known as thrombotic microangiopathy (TMA) in people taking this medication. Alert your healthcare provider right away if you have any signs or symptoms of TMA, such as:
    • Unusual bruising or bleeding
    • Drowsiness, fatigue, confusion, or seizures
    • Water retention
    • Decreased urination
    • Fever.
 
  • Keep all of your healthcare provider and laboratory appointments while undergoing Votrient treatment. You will need routine tests to monitor for potentially serious side effects.
 
  • Some people may experience diarrhea while taking this medicine. Talk to your healthcare provider about the best ways to manage diarrhea if you experience this. Severe or ongoing diarrhea can be dangerous and will need to be treated by your healthcare provider.

 

  • Pneumothorax has been reported in people taking Votrient. A pneumothorax occurs when air becomes trapped in the space around the lungs, causing the lung to collapse. Signs of this rare but dangerous condition include chest pain and shortness of breath.
 
  • Studies in young rats suggest that this medication could be quite dangerous in children, particularly young children. Giving Votrient to young rats (equivalent to under two years old in humans) resulted in toxicity to the lungs, heart, liver, and kidneys, as well as other problems, including death. Votrient is not approved for use in children.

  

  • Talk to your healthcare provider before getting any type of vaccination or immunization during Votrient treatment. Vaccinations may be less effective while taking this drug. You could also become infected with the bacteria or viruses used to make "live" vaccines (see Votrient Drug Interactions).
 
 
  • This product is a pregnancy Category D medication, which means it may be harmful to an unborn child. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant (see Votrient and Pregnancy).
 
  • It is unknown whether Votrient 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 Votrient and Breastfeeding).
 
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Votrient Medication Information

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