Ponatinib Oral Tablet

Name: Ponatinib Oral Tablet

Highlights for ponatinib

Ponatinib is used to treat two types of cancer: chronic myeloid leukemia and acute lymphoblastic leukemia.

This drug comes as a tablet you take by mouth.

This drug is available as the brand-name drug Iclusig. It’s not available as a generic drug.

The more common side effects of this drug include skin rash, pain in your abdomen, tiredness, and headache. They also include dry skin, constipation, fever, joint pain, and nausea.

In some cases, this drug can cause serious side effects. Some of these include blood clots, high blood pressure, inflammation of your pancreas, serious bleeding, and problems with your heart, liver, or eyes. Serious side effects also include nerve damage, wound healing problems, tears in the lining of your stomach, kidney problems caused by tumor lysis syndrome, and low blood cell levels that can lead to infection.

IMPORTANT INFORMATION
  • FDA warning See Details

  • Low blood cell levels See Details

  • Fluid buildup See Details

  • High blood pressure See Details

What is ponatinib?

Ponatinib is a prescription drug. It comes as a tablet you take by mouth. It’s available as the brand-name drug Iclusig. It’s not available as a generic drug.

Why it's used

Ponatinib is used to treat adults who have a specific type of abnormal gene (T315I-positive) chronic myeloid leukemia (CML).

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How it works

Ponatinib belongs to a class of drugs called kinase inhibitors. A class of drugs is a group of medications that work in a similar way.

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Ponatinib Side Effects

More common side effects

The more common side effects of ponatinib can include:

  • skin rash

  • constipation

  • pain in your abdomen

  • fever

  • tiredness

  • join pain

  • headache

  • nausea

  • dry skin

If these side effects are severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • High blood pressure. Symptoms can include:

    • headaches
    • dizziness
    • chest pain
    • shortness of breath
  • Pancreatitis (inflammation of your pancreas). Symptoms can include:

    • sudden pain in your abdomen
    • nausea
    • vomiting
  • Neuropathy (damage to nerves in your arms, legs, hands, feet, or brain). Symptoms can include:

    • muscle weakness
    • tingling
    • burning
    • pain
    • loss of feeling in your hands and feet
    • double vision
    • trouble moving your eyes
    • sagging or drooping eyelids
    • drooping of part of your face
  • Effects on your eyes that can lead to blindness or blurry vision. Symptoms can include:

    • seeing flashes of light
    • light sensitivity
    • seeing floaters (small particles that seem to float across your vision)
    • dry or itchy eyes
    • eye pain
  • Severe bleeding. Symptoms can include:

    • vomit that contains blood or looks like coffee grounds
    • pink or brown urine
    • red or black tar-like stools
    • coughing up blood or blood clots
    • unusual bleeding or bruising of your skin
    • periods that are heavier than normal
    • unusual vaginal bleeding
    • nose bleeds that happen often
    • drowsiness or trouble waking
    • confusion
    • headache
    • change in speech
  • Fluid retention. Symptoms can include:

    • swelling of your hands, ankles, feet, face, or entire body
    • weight gain
    • shortness of breath and cough
  • Low blood cell counts. Symptoms can include:

    • fever
    • signs of infection, such as coughing, sore throat, or runny or stuffy nose
    • tiredness
    • paleness
  • Kidney disease caused by tumor lysis syndrome (a condition caused by the fast breakdown of cancer cells). Symptoms can include:

    • abnormal heart rate
    • seizures
    • decreased urination
    • nausea
    • vomiting
  • A tear in your stomach or intestinal wall. Symptoms can include:

    • severe pain in your abdomen
    • swelling of your abdomen
    • high fever
  • Heart failure. Symptoms can include:

    • swelling in your legs
    • weight gain
    • tiredness
    • shortness of breath
  • Irregular heart rhythm. Symptoms can include:

    • lightheadedness
    • dizziness
    • fainting
    • chest pain
  • Reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms can include:

    • seizures
    • headache
    • loss of vision
    • decreased alertness
    • trouble thinking
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Ponatinib May Interact with Other Medications

Ponatinib can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

Don’t eat grapefruit or drink grapefruit juice if you’re taking ponatinib. Grapefruit can lead to an increased amount of ponatinib in your body. This can cause more side effects.

Medications that might interact with this drug

Interactions that increase your risk of side effects

Taking ponatinib with certain drugs raises your risk of side effects from ponatinib. This is because the amount of ponatinib in your body may be increased. Examples of these drugs include:

  • Boceprevir, clarithromycin, conivaptan, posaconazole, voriconazole, lopinavir/ritonavir, nefazodone, nelfinavir, saquinavir, telaprevir, itraconazole, ketoconazole, telithromycin, and indinavir
    • Your doctor will likely reduce your starting dosage of ponatinib if you’re taking any of these drugs.
Interactions that can make ponatinib less effective

When used with ponatinib, these drugs can make ponatinib less effective. That means it won’t work as well to treat your condition. This is because the amount of ponatinib in your body may be decreased. Examples of these drugs include:

  • St. John’s wort, rifampin, phenytoin, and carbamazepine
    • Your doctor will likely monitor you closely for signs that ponatinib is not working as well as it should.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Ponatinib warnings

People with liver disease

If you have liver problems or a history of liver disease, you may not be able to clear this drug from your body very well. This may increase the levels of ponatinib in your body and cause more side effects.

Pregnant women

Ponatinib is a category D pregnancy drug. That means two things:

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or plan to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus. This drug should only be used if the potential risk to the fetus is acceptable given the drug’s potential benefit.

If you’re a woman of childbearing age who is not pregnant, be sure to use birth control throughout your treatment with ponatinib. Continue to use birth control for three weeks after your last dose of the drug.

If you’re a woman of childbearing age, ponatinib could make you less likely to become pregnant. It’s not known if this effect goes away after you stop taking the drug. If you may want to have children in the future, talk to your doctor about whether ponatinib is safe for you.

Women who are breast-feeding

It is not known if ponatinib can pass into breast milk and cause side effects in a child who is breastfed.

Do not breastfeed during your treatment with ponatinib. Also avoid breastfeeding for six days after your last dose of the drug.

For seniors

If you’re older than 65 years of age, you may be at higher risk of developing side effects. The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children

Ponatinib has not been established as safe and effective for use in children. It should not be used in people younger than 18 years of age.

When to call the doctor

Call your doctor if you need to have surgery. This drug can make it harder for you to recover after surgery. Your doctor may have you stop taking this drug for a short period.

Call your doctor right away if you become pregnant while taking this drug.

Allergies

Ponatinib can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

How to Take ponatinib (Dosage)

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Chronic myeloid leukemia

Brand: Iclusig

Form: oral tablet Strengths: 15 mg, 45 mg Adult dosage (ages 18–64 years)

45 mg taken once per day. Your doctor may change your dosage or stop your treatment if you have certain serious side effects.

Child dosage (ages 0–17 years)

It has not been confirmed that ponatinib is safe and effective for use in people younger than 18 years of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a decreased dosage or a different treatment schedule. This can help keep this drug from building up too much in your body.

Special considerations

The typical starting dosage is 30 mg taken once per day.

Acute lymphoblastic leukemia

Brand: Iclusig

Form: oral tablet Strengths: 15 mg, 45 mg Adult dosage (ages 18–64 years)

45 mg taken once per day. Your doctor may change your dosage or stop your treatment if you have certain serious side effects.

Child dosage (ages 0–17 years)

It has not been confirmed that ponatinib is safe and effective for use in people younger than 18 years of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a decreased dosage or a different treatment schedule. This can help keep this drug from building up too much in your body.

Special considerations

The typical starting dosage is 30 mg taken once per day.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important considerations for taking ponatinib

You can take ponatinib with or without food

Take this drug at the time(s) recommended by your doctor

Do not cut, crush, or dissolve the tablets. You should swallow them whole

Store this drug carefully

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A prescription for this medication is refillable

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Travel

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Clinical monitoring

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Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Insurance

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Show Sources

  • ARIAD Pharmaceuticals, Inc. (2014, July). Iclusig (ponatinib) tablets for oral use [package insert]. Cambridge, MA.
  • Iclusig (ponatinib) tablets for oral use. (2016, November). Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on March 9, 2017

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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