Side Effects of ICLUSIG® (ponatinib)

Important information about side effects

The information shown are highlights from the Important Safety Information. Please scroll down to see more details.

ICLUSIG can cause serious side effects, including:

  • Blood clots or blockage in your blood vessels (arteries and veins)
  • Heart problems
  • Liver problems

Other serious side effects seen with ICLUSIG include:

  • High blood pressure (hypertension)
  • Inflammation of the pancreas (pancreatitis)
  • Neuropathy
  • Eye problems
  • Bleeding
  • Fluid retention
  • Irregular heartbeat
  • Low blood cell counts
  • Tumor lysis syndrome (TLS)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome)
  • Wound healing problems
  • A tear in your stomach or intestinal wall (perforation)

ICLUSIG was shown to cause some side effects more often than others

The information shown are highlights from the Important Safety Information below. Please scroll down to see more details.

The most common side effects of ICLUSIG when given alone include:

  • Skin rash
  • Joint pain
  • Stomach-area (abdomen) pain
  • Headache
  • Constipation
  • Dry skin
  • Tiredness
  • Swelling of your hands, ankles, feet, face, or all over your body (fluid retention and edema)
  • Fever
  • Nausea
  • Increase in lipase levels (a blood test done to check your pancreas)
  • Low hemoglobin in the blood (anemia)
  • Liver problems
  • Blood clots or blockage in blood vessels (arteries)
  • Low blood platelet counts
  • Low blood levels of white blood cells

The most common side effects of ICLUSIG when given with chemotherapy include:

  • Liver problems 
  • Joint pain
  • Skin rash  
  • Headache
  • Fever
  • Stomach-area (abdomen) pain 
  • Constipation 
  • Tiredness
  • Nausea
  • Mouth sores
  • Increase in lipase levels (a blood test done to check your pancreas)
  • Numbness, or tingling (pins and needles), pain, or weakness in the hands or feet
  • Fever due to low white blood cell counts (febrile neutropenia)
  • Swelling of your hands, ankles, feet, face, or all over your body (fluid retention and edema)
  • Vomiting 
  • Irregular heartbeat
  • Low blood levels of white blood cells 
  • Low blood platelet counts 
  • Low hemoglobin in the blood (anemia) 
  • Changes in liver function tests

These are not all of the possible side effects of ICLUSIG. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

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