Iclusig Warnings and Precautions

Reviewing the precautions and warnings associated with Iclusig before starting chemotherapy with this drug can help prevent potentially dangerous complications. Although it can be an effective medicine in many cases, this may not be an appropriate choice for people who have a history of liver problems, blood clots, or pancreatitis. Other risks also apply to women who are pregnant or nursing.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Iclusig® (ponatinib) if you have:
   
Also, let your healthcare provider know if you are:
 
  • A frequent alcohol drinker
  • 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 Precautions and Warnings for Iclusig

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Iclusig may increase the risk for blood clots in the arteries or veins. This can lead to heart attacks, strokes, or other serious complications. This very serious risk must be considered before you start treatment with this drug. As many as 27 percent of people taking this medication will develop a blood clot of some sort.
 
  • This medication can cause liver toxicity, including fatal liver failure. Your healthcare provider should monitor your liver function, using simple blood tests, starting before you begin treatment with Iclusig and continuing at least once a month.
 
  • Up to 71 percent of people taking Iclusig develop high blood pressure (hypertension). Your healthcare provider should monitor your blood pressure during treatment.
 
  • Iclusig may increase the risk for pancreatitis (dangerous inflammation of the pancreas). In order to monitor for this problem, your healthcare provider should check your serum lipase, using a blood test, at least once every two weeks for the first two months, followed by monthly testing thereafter. People who have had pancreatitis in the past or who abuse alcohol may need even more frequent lipase testing.
 
  • This medication may cause irregular heart rhythms (arrhythmias). Let your healthcare provider know immediately if you experience any signs of this problem, such as:
    • Lightheadedness
    • Dizziness
    • Fainting
    • Chest palpitations.
 
  • This medication may cause low blood cell counts, including low platelets (thrombocytopenia), low red blood cells (anemia), and low white blood cells (neutropenia). A low platelet count increases the risk for dangerous bleeding, while a low white blood cell count increases the risk for infection. Your healthcare provider will monitor your blood counts, with blood tests, routinely during treatment. Let your healthcare provider know right away if you develop a fever, signs of infection, or unusual bleeding or bruising.
 
  • Iclusig can cause the body to retain fluid, which could lead to potentially serious problems, especially if the fluid builds up around the lining of the heart, lungs, or stomach. Let your healthcare provider know if you have signs of fluid retention (known as edema), such as:
    • Unexplained weight gain
    • Swelling in any area of your body
    • Shortness of breath
    • Cough
    • Chest pain.
 
  • Based on the way it works, Iclusig could, at least theoretically, interfere with wound healing. Therefore, it is usually recommended to stop taking the drug for one week before major surgeries.
   
  • Iclusig is 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 Iclusig and Pregnancy).
 
  • It is unknown whether Iclusig 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 Iclusig and Breastfeeding).
 
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Iclusig Chemotherapy Information

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