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Precautions and Warnings With Sorafenib

Prior to starting treatment with sorafenib, your healthcare provider needs to know if you have a history of problems with your liver, kidneys, or heart. Other precautions for safely using sorafenib include warnings of potential drug interactions and allergic reactions. This medicine can increase your risk for other complications, such as bleeding problems, skin reactions, and heart attacks.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking sorafenib (Nexavar®) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Sorafenib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • This medication has been reported to cause decreased blood flow to the heart, which could result in a heart attack. Seek immediate medical attention if you experience signs of a heart attack, such as:
    • Chest pain
    • Shortness of breath
    • Lightheadedness
    • Increased sweating
    • Nausea.
  • Sorafenib may increase your risk for bleeding, including potentially life-threatening bleeding of the gastrointestinal tract (digestive tract) and brain. Let your healthcare provider know if you develop any signs of bleeding, such as:
    • Unusual bruising
    • Coughing up blood
    • 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.
  • You may develop high blood pressure (hypertension) while taking sorafenib. Your healthcare provider will check your blood pressure every week for the first six weeks of treatment and then regularly thereafter. If your blood pressure becomes too high, your healthcare provider may recommend high blood pressure medications.
  • People taking sorafenib may develop skin reactions, including a rash and a skin problem known as hand-foot skin reaction. Hand-foot skin reaction causes redness, blistering, swelling, and pain on the palms of the hands and soles of the feet. Skin reactions are more likely to occur in the first six weeks of treatment, but can happen at any time. Contact your healthcare provider if you experience any skin problems. He or she may be able to treat the condition, or may need to change your sorafenib dosage.
  • There have been rare cases in which sorafenib caused a hole in the lining of the digestive tract, known medically as a gastrointestinal perforation. Seek immediate medical attention if you develop signs of this serious problem, such as:
    • Fever
    • Nausea and vomiting
    • Severe abdominal (stomach) pain.
  • Wounds or sores may not heal properly while you are taking this medication. Contact your healthcare provider right away if you have wounds that are red, oozing, or appear infected. Also, tell your healthcare provider if you have plans for surgery. You may need to temporarily stop taking sorafenib.
  • This medication may cause a potentially life-threatening heart rhythm problem known as QT prolongation. Your healthcare provider will monitor the electrical activity of your heart with an electrocardiogram (ECG) during treatment. He or she will also monitor the levels of potassium, magnesium, and calcium in your blood, especially if you have underlying heart problems or take certain other medicines that also increase the risk for QT prolongation (see Drug Interactions With Sorafenib).
  • Sorafenib has been reported to cause liver failure, which can be fatal. Contact your healthcare provider if you experience symptoms of liver problems, such as:
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Fatigue
    • Pain in the upper-right area of the abdomen (stomach)
    • Nausea and vomiting
    • Dark urine.
  • This product is a pregnancy Category D medication, which means it can harm an unborn baby if taken during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant (see Nexavar and Pregnancy).
  • It is not known whether sorafenib 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 Nexavar and Breastfeeding).
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