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What are the possible side effects of ICLUSIG® (ponatinib)?

Talk to your healthcare provider about any side effects you may experience with ICLUSIG.

What is the most important information
I should know about ICLUSIG?

ICLUSIG can cause serious side effects including:

Blood clots or blockage in your blood vessels (arteries and veins). Blood clots or blockage in your blood vessels may lead to heart attack, stroke, or death. A blood clot or blockage in your blood vessels can prevent proper blood flow to your heart, brain, bowels (intestines), legs, eyes, and other parts of your body. You may need emergency surgery or treatment in a hospital. Get medical help right away if you get any of the following symptoms:

  • chest pain or pressure
  • pain in your arms, legs, back, neck or jaw
  • shortness of breath
  • numbness or weakness on one side of your body
  • leg swelling
  • trouble talking
  • headache
  • dizziness
  • severe stomach area pain
  • decreased vision or loss of vision

Blood clots or blockage in your blood vessels can happen in people with or without risk factors for heart and blood vessel disease, including people 50 years of age or younger. The most common risk factors for these problems are a history of high blood pressure (hypertension), high levels of fat in the blood (hyperlipidemia), and heart disease. Blood clots or blockages in your blood vessels happen more often in people as they get older, and in people with a past history of decreased blood flow, high blood pressure, diabetes, or high levels of fats in the blood.

Heart problems. ICLUSIG can cause heart problems, including heart failure which can be serious and may lead to death. Heart failure means your heart does not pump blood well enough. ICLUSIG can also cause irregular slow or fast heartbeats and heart attack. Your healthcare provider will check you for heart problems during your treatment with ICLUSIG. Get medical help right away if you get any of the following symptoms: shortness of breath, chest pain, fast or irregular heartbeats, dizziness, or feel faint.

Liver problems. ICLUSIG can cause liver problems, including liver failure, which can be severe and may lead to death. Your healthcare provider will do blood tests before and during your treatment with ICLUSIG to check for liver problems. Get medical help right away if you get any of these symptoms of liver problems during treatment:

  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark "tea-colored" urine
  • sleepiness
  • loss of appetite
  • bleeding or bruising

What are the possible side effects of ICLUSIG?

ICLUSIG may cause serious side effects, including:

  • High blood pressure.

    Your blood pressure should be checked regularly and any high blood pressure should be treated while you are taking ICLUSIG. Tell your healthcare provider if you get confusion, headaches, dizziness, chest pain or shortness of breath.

  • Inflammation of the pancreas (pancreatitis).

    Tell your healthcare provider if you get any of the following symptoms: sudden stomach-area pain or discomfort, nausea, and vomiting. Your healthcare provider should do blood tests to check for pancreatitis during treatment with ICLUSIG.

  • Neuropathy.

    ICLUSIG may cause damage to the nerves in your arms, brain, hands, legs, or feet (neuropathy). Tell your healthcare provider if you get any of these symptoms during treatment with ICLUSIG:

    • muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet
    • double vision and other problems with eyesight, trouble moving the eye, drooping of part of the face, sagging or drooping eyelids, and change in taste
  • Effects on the eye.

    Serious eye problems that can lead to blindness or blurred vision may happen with ICLUSIG. Tell your healthcare provider if you get any of the following symptoms: bleeding in the eye, perceived flashes of light, light sensitivity, floaters, dry inflamed, swollen, or itchy eyes, and eye pain. Your healthcare provider will monitor your vision before and during your treatment with ICLUSIG.

  • Severe bleeding.

    ICLUSIG can cause bleeding which can be serious and may lead to death. Tell your healthcare provider if you get any signs of bleeding during treatment with ICLUSIG including:

    • vomiting blood or if your vomit looks like coffee-grounds
    • pink or brown urine
    • red or black (looks like tar) stools
    • coughing up blood or blood clots
    • unusual bleeding or bruising of your skin
    • menstrual bleeding that is heavier than normal
    • unusual vaginal bleeding
    • nose bleeds that happen often
    • drowsiness or difficulty being awakened
    • confusion
    • headache
    • change in speech
  • Fluid retention.

    Your body may hold too much fluid (fluid retention). Tell your healthcare provider right away if you get any of these symptoms during treatment with ICLUSIG:

    • swelling of your hands, ankles, feet, face, or all over your body
    • weight gain
    • shortness of breath and cough
  • Irregular heartbeat.

    ICLUSIG may cause an irregular heartbeat. Tell your healthcare provider right away if you experience loss of consciousness, fainting, dizziness, chest pain or palpitations.

  • Low blood cell counts.

    ICLUSIG may cause low blood cell counts, which can be severe. Your healthcare provider will check your blood counts regularly during treatment with ICLUSIG. Tell your healthcare provider right away if you have a fever or any signs of an infection while taking ICLUSIG.

  • Tumor Lysis Syndrome (TLS).

    TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:

    • kidney failure and the need for dialysis treatment
    • an abnormal heartbeat
  • Your healthcare provider may do blood tests to check for TLS.

  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome - PRES).

    ICLUSIG may trigger a condition called RPLS. Call your healthcare provider right away if you get headaches, seizures, confusion, changes in vision or problems thinking.

  • Possible wound healing problems.

    If you need to have a surgical procedure, tell your healthcare provider that you are taking ICLUSIG. You should stop taking ICLUSIG at least 1 week before any planned surgery.

  • A tear in your stomach or intestinal wall (perforation).

    Tell your healthcare provider right away if you get:

    • severe pain in your stomach-area (abdomen)
    • swelling of the abdomen
    • high fever

The most common side effects of ICLUSIG include:

  • stomach-area (abdomen) pain
  • skin rash
  • constipation
  • headache
  • dry skin
  • blood clots or blockage in blood vessels (arteries)
  • tiredness
  • high blood pressure
  • fever
  • joint pain
  • nausea
  • diarrhea
  • increase in lipase levels (a blood test done to check your pancreas)
  • vomiting
  • muscle pain
  • pain in arms, hands, legs, and feet

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ICLUSIG if you have certain side effects.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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. You may report side effects to
1-800-FDA-1088.

How should I store ICLUSIG?

Store ICLUSIG at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ICLUSIG and all medicines out of the reach of children.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda at 1-844-T-1POINT (1-844-817-6468) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

These are not all the possible side effects of ICLUSIG. For more information, ask your healthcare team.

How do I work with my healthcare provider to help
identify any side effects?

By working with your healthcare provider, you can help identify signs and symptoms of side effects.

Starting a new treatment can be overwhelming. It can feel like there is a lot to learn. Take your time, read the Medication Guide and ask questions. It is important to talk with your healthcare provider about any side effects you may experience. Together you can see if there are things you can do to help manage them. The following are some tips that may help.

Look out for the signs and symptoms of ICLUSIG side effects.

Some people taking ICLUSIG have experienced side effects that are serious or even fatal.
It’s important to know the signs and symptoms of ICLUSIG side effects as some may need medical treatment, and your healthcare provider may need to adjust your treatment.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Take care of your cardiovascular health.

Cardiovascular side effects, including heart problems and blood clots can happen with ICLUSIG. High cholesterol, diabetes, and high blood pressure can increase these risks. A healthy diet, exercise, and stopping smoking may decrease the risk of cardiovascular side effects.

Talk to your healthcare provider if you are a woman who is pregnant, breastfeeding, or could become pregnant.

ICLUSIG can harm unborn children. You should not become pregnant if you are taking ICLUSIG.
Use an effective form of birth control during treatment and for 3 weeks after your last dose.
Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ICLUSIG.
ICLUSIG may affect your ability to have children. Tell your healthcare provider if this is a concern for you.
It is not known if ICLUSIG passes into your breast milk. Do not breastfeed while you are taking ICLUSIG and for 6 days after your last dose.

Try not to skip medications, tests, or medical appointments.

Your disease may get worse if you skip treatment. Talk to your team if you find it difficult to take your treatment as recommended.

Tell your healthcare provider about your other medical conditions.

Some medical conditions can increase your risk of experiencing side effects with ICLUSIG® (ponatinib). Before you take ICLUSIG, tell your healthcare provider about all of your medical conditions, including if you have:

  • A history of blood clots in your blood vessels (arteries or veins)
  • Heart problems, including heart failure, irregular heartbeats, and QT prolongation
  • Diabetes
  • A history of high cholesterol
  • Liver problems
  • Had inflammation of your pancreas (pancreatitis)
  • High blood pressure
  • Bleeding problems
  • Plan to have any surgical procedures or have had a recent surgery
  • Are lactose (milk sugar) intolerant. ICLUSIG tablets contain lactose.
  • Drink grapefruit juice
  • Are pregnant or plan to become pregnant. ICLUSIG can harm your unborn baby.
    • Your healthcare provider will do a pregnancy test before you start taking ICLUSIG.
    • You should not become pregnant during treatment with ICLUSIG.

You should also tell your healthcare provider if you are lactose intolerant (ICLUSIG tablets contain lactose) or if you are planning to have any surgical procedures or have had recent surgery.

Tell your medical team about all the medicines you take.

Some prescription medications, over-the-counter medicines, vitamins, and herbal supplements may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

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The information provided on this site is intended for informational purposes and cannot replace individualized guidance from a healthcare provider. Be sure to talk with your healthcare provider about making any change to your healthcare regimen. The information on this site is intended for residents of the United States only. Product labeling may be different in other countries.