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Caprelsa Warnings and Precautions

Specific Precautions and Warnings With Caprelsa

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • There have been reports of heart failure in people taking Caprelsa, sometimes leading to death. Heart failure from Caprelsa may not go away after the medication is stopped. Therefore, your healthcare provider will monitor you for this problem during treatment.
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  • Caprelsa may cause a potentially dangerous problem with the heart rhythm known as QT prolongation. Your healthcare provider will monitor you for this before you start treatment and regularly thereafter. Monitoring will include blood tests to check your potassium, magnesium, calcium, and thyroid-stimulating hormone levels, as well as an electrocardiogram (ECG) to check the electrical activity of your heart.
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  • Your skin may be more sensitive to the sun during Caprelsa treatment, and for four months after treatment ends. Therefore, try to limit your sun exposure, and wear sunscreen and protective clothing that covers your skin when you go outside.
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  • This medication can cause skin reactions, including a potentially life-threatening skin rash known as Stevens-Johnson syndrome (SJS). Contact your healthcare provider right away if you experience any rash or other skin problem during Caprelsa treatment. Your healthcare provider will tell you if you need to stop taking the drug. In some cases, the skin reaction may be easily treated with another medication.
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  • Caprelsa can cause a potentially life-threatening lung problem known as interstitial lung disease. Contact your healthcare provider right away if you experience shortness of breath or a new or worsening cough while taking this drug.
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  • There have been reports of strokes in people taking this medication. Seek immediate medical care if you develop symptoms of a stroke during treatment, including a sudden severe headache; weakness on one side of the body; confusion; or trouble walking, talking, or seeing.
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  • Caprelsa has been reported to cause life-threatening bleeding. Let your healthcare provider know if you have severe bleeding or signs of this problem, such as:
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    • 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.
 
  • Most people who take this medication will experience diarrhea. Talk to your healthcare provider about ways to manage diarrhea during Caprelsa treatment. Severe or persistent diarrhea can cause dehydration and electrolyte imbalance (abnormal levels of blood salts, such as calcium, magnesium, and potassium), which could increase your risk for other side effects.
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  • Caprelsa may cause high blood pressure (hypertension). Your healthcare provider will monitor your blood pressure during treatment. If your blood pressure increases too much, you may need to either take high blood pressure medication or temporarily stop taking Caprelsa.
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  • Caprelsa has been reported to cause a brain condition known as reversible posterior leukoencephalopathy syndrome. Contact your healthcare provider right away if you develop symptoms of this condition, which include:
 
    • Headaches
    • Confusion
    • Changes in vision
    • Difficulty thinking
    • Seizures.
     
  • This medication may cause a change in your levels of thyroid hormone. Your healthcare provider will routinely monitor your thyroid hormone levels with a blood test during treatment.
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  • People with kidney disease may need a lower Caprelsa dosage. This medication is not recommended for use in people with moderate-to-severe liver disease.
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  • Caprelsa can interact with a number of other medications (see Caprelsa Drug Interactions).
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  • This medication is considered a pregnancy Category D medication, which means it may harm an unborn child if taken by a pregnant woman. Talk to your healthcare provider about the risks and benefits of using this drug when pregnant (see Caprelsa and Pregnancy).
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  • It is unknown if Caprelsa passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Caprelsa and Breastfeeding).
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