Ponatinib | Side Effects, Dosage, Uses & More
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Generic Name:

ponatinib, Oral tablet

All Brands

  • Iclusig
SECTION 1 of 5

Highlights for ponatinib

Oral tablet
1

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

2

This drug comes as a tablet you take by mouth.

3

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

4

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.

5

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

This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.

Blood vessel blockage warning. Taking this drug raises your risk of developing blood clots in your blood vessels. This can prevent proper blood flow and can lead to heart attack, stroke, and death. Call 9-1-1 right away if you have:

  • pain or pressure in your chest
  • shortness of breath
  • numbness or weakness on one side of your body
  • decreased vision
  • loss of vision
  • trouble talking
  • pain in your arms, legs, back, neck, or jaw

Heart problems warning. This drug can cause heart problems, including heart failure, irregular heart rhythm, and heart attack. These can be serious and may lead to death. Your healthcare provider will check your heart function before and during your treatment with this drug. Call your doctor or 9-1-1 right away if you have any of the following symptoms:

  • shortness of breath
  • chest pain
  • fast or irregular heart rate
  • dizziness
  • feeling faint

Liver disease warning. This drug can cause liver disease, including liver failure. This can be severe and may lead to death. Your healthcare provider will likely do blood tests before and during your treatment with this drug to check for liver problems. Call your doctor right away if you have any symptoms of liver disease during treatment, such as:

  • yellowing of your skin or the whites of your eyes
  • dark tea-colored urine
  • unusual sleepiness

Low blood cell levels

This drug can decrease your number of platelets, white blood cells, and red blood cells. This effect can lead to serious bleeding or infection. If your levels are too low, your doctor will stop or reduce your dosage.

Fluid buildup

This drug may cause a buildup of fluid in certain parts of your body. This can lead to swelling in your arms, legs, hands, or feet. Your doctor may pause, reduce, or stop your use of this drug if this happens.

High blood pressure

This drug may cause you to develop high blood pressure or make your high blood pressure worse. Your doctor may check your blood pressure before and during your treatment with this drug.

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).

See Details

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.

See Details

Why it's used

Ponatinib is used to treat adults who have a specific type of abnormal gene (T315I-positive) chronic myeloid leukemia (CML). It’s used when the cancer is in the chronic, accelerated, or blast phase. This drug can also be used to treat T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Leukemia is a cancer of white blood cells. An excessive number of these cells form and crowd out the normal, healthy cells in the body. Leukemia can be acute or chronic. Acute leukemia grows very fast. With chronic leukemia, the cells grow over a longer time.

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.

Ponatinib blocks the growth of cancer cells by targeting certain proteins found on the cancer cells. This stops the cells from multiplying (making copies of themselves).

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SECTION 2 of 5

ponatinib Side Effects

Oral tablet

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
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Ponatinib causes tiredness. Do not drive or operate heavy machinery until you know you can function normally.

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.
SECTION 3 of 5

ponatinib May Interact with Other Medications

Oral tablet

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
liver 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.

pregnancy warning
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.

breast feeding warning
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.

Talk to your doctor about breastfeeding your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

senior warning
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.

childrens warning
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.

call the doctor
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.

allergy warning
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).

SECTION 4 of 5

How to Take ponatinib (Dosage)

Oral tablet

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.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all

You cancer may get worse. The leukemia cells in your blood can take over your normal, healthy cells. This can lead to serious problems and possibly death.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much

You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • abnormal heart rhythm
  • fast pulse
  • fever
  • shortness of breath
  • fatigue
  • chest pain

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room right away.

What to do if you miss a dose

Take your dose at the next regular time. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working

You may have more energy, fewer infections, and less bruising or bleeding. However, the only way to know for sure that the drug is working is through the results of tests your doctor will do.

Ponatinib may be used for short-term or long-term treatment.

Important considerations for taking ponatinib
with or without food
You can take ponatinib with or without food
timing considerations
Take this drug at the time(s) recommended by your doctor
no crush or cut
Do not cut, crush, or dissolve the tablets. You should swallow them whole
storage considerations
Store this drug carefully
See Details
medication is refillable
A prescription for this medication is refillable
See Details
travel considerations
Travel
See Details
clinical monitoring
Clinical monitoring
See Details
not usually stocked
Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead
prior authorization needed
Insurance
See Details

Store this drug carefully

  • Store ponatinib at room temperature between 68°F and 77°F (20°C and 25°C).
  • Don’t store this medication in moist or damp areas, such as bathrooms.

A prescription for this medication is refillable

You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

You and your doctor should watch for certain health problems during your treatment. This can help make sure you stay safe while you take this drug. These problems include:

  • High blood pressure. Your doctor will likely monitor your blood pressure. If it’s high, your doctor may prescribe a drug to help keep it under control.
  • Pancreatitis. Your doctor may do blood tests to make sure you don’t develop pancreatitis.
  • Abnormal blood cell levels. Your doctor may check your blood cell counts every 2 weeks for 3 months. After that, they may check them once every month.
  • Eye and vision problems. You should have a full eye exam before starting treatment with ponatinib. Also get an eye exam as directed by your doctor while taking ponatinib.
  • Fluid retention. Your doctor will likely monitor you for swelling of your arms, legs, hands, feet, and ankles. If you have swelling, your doctor may reduce your dosage or stop your treatment with this drug.
  • Liver function problems. Your doctor may do blood tests to check your liver function. If your liver function is decreased, your doctor may have you stop taking ponatinib.
  • Nerve damage. Your doctor will likely monitor for symptoms of nerve damage, such as tingling, burning, numbness, or pain in your arms, legs, hands, or feet. They’ll likely also watch for nerve damage in your brain. This damage can cause double vision and trouble moving your eyes.
  • Heart problems. Your doctor will likely check your heart function before and during your treatment with ponatinib.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

What does the pill look like?

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SECTION 5 of 5

How Much Does ponatinib Cost?

Oral tablet

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Lowest price for ponatinib

Kroger Pharmacy $6,030.25
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These prices represent the lowest priced national pharmacies for ponatinib on GoodRx. They may be lower than your insurance.

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These prices represent the lowest priced national pharmacies for ponatinib on GoodRx. They may be lower than your insurance.

Show Sources

  • ARIAD Pharmaceuticals, Inc. (2014, July). Iclusig (ponatinib) tablets for oral use [package insert]. Cambridge, MA. 

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 10, 2016

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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