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Precautions and Warnings With Regorafenib

Potentially serious complications, such as severe liver problems, may occur in some people who take regorafenib. To help ensure a safe treatment, there are a number of safety precautions and warnings for regorafenib, particularly for those who have problems with their heart, kidneys, or liver. Other risks apply to people taking certain medications and women who are pregnant or nursing.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to taking regorafenib (Stivarga®) if you have:
  • Liver disease, such as hepatitis or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • High blood pressure (hypertension)
  • Chest pain or heart problems
  • Had a heart attack
  • Plans to have surgery or dental work (such as a tooth extraction)
  • Had a recent surgery
  • Bleeding problems
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Regorafenib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Regorafenib has been reported to cause serious liver problems, some of which may be fatal. People whose cancer has spread to the liver may have a higher risk for liver problems with regorafenib treatment. Your healthcare provider will monitor your liver function using blood tests before you start regorafenib, and routinely during treatment. Contact your healthcare provider if you experience signs of liver disease, such as:
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Fatigue
    • Upper-right abdominal (stomach) pain
    • Nausea and vomiting
    • Dark urine.
  • People treated with regorafenib are at risk for serious bleeding problems, which can sometimes be severe enough to cause death. Let your healthcare provider know immediately if you experience any signs of bleeding problems, such as:
    • Blood in your urine or stool
    • Coughing or vomiting up blood
    • Any unusual bleeding.
  • Regorafenib may cause a condition known as hand-foot skin reaction. Hand-foot skin reaction can cause burning, pain, redness, swelling, bleeding, sores, or blisters on the palms of the hands or soles of the feet. Let your healthcare provider know if you develop any of these symptoms or experience a skin rash during regorafenib treatment.
  • People who take this medicine may develop hypertension (high blood pressure). Your healthcare provider will monitor your blood pressure regularly during treatment. If your blood pressure becomes elevated, you may need to take high blood pressure medications. If your blood pressure becomes too high, or cannot be controlled with medicines, your healthcare provider may recommend you stop taking regorafenib.
  • Regorafenib may decrease blood flow to the heart, which could lead to a heart attack. Seek immediate medical attention if you are taking this medicine and experience any signs of heart problems, such as:
    • Chest pain
    • Shortness of breath
    • Dizziness
    • Feeling like you might pass out.
  • Although rare, regorafenib may cause a tear in the gastrointestinal (GI) tract (known medically as a GI perforation), or a GI fistula, which is an abnormal opening of the GI tract that allows the contents of the stomach or intestines to leak out. Let your healthcare provider know if you experience potential signs of these problems, such as:
    • Severe abdominal (stomach) pain
    • Abdominal (stomach) swelling
    • High fever
    • Severe diarrhea
    • Dehydration.
  • Medications like regorafenib can interfere with wound healing. You will need to stop taking this medicine at least two weeks prior to any scheduled surgery, so that your surgical wounds can heal properly. Your healthcare provider will let you know when you can start taking regorafenib again after your surgery.
  • Regorafenib may rarely cause a serious brain condition known as reversible posterior leukoencephalopathy. Contact your healthcare provider right away if you have signs of this condition, which can include:
  • It is unknown if regorafenib 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 Stivarga and Breastfeeding).
  • Regorafenib is a pregnancy Category D medication, which means it may harm an unborn child if taken during pregnancy (see Stivarga and Pregnancy).
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Regorafenib Drug Information

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