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Generic Name: ponatinib (poe NA ti nib)
Brand Name: Iclusig

Medically reviewed by on Jan 7, 2019 – Written by Cerner Multum

What is ponatinib?

Ponatinib is used in adults to treat a type of blood cancer called chronic myeloid leukemia (CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).

Ponatinib is usually given after other treatments have failed.

Ponatinib may also be used for purposes not listed in this medication guide.

Important Information

Ponatinib may cause heart or blood vessel problems that could lead to heart attack or stroke.

Call your doctor or get emergency medical help if you have: chest pain spreading to your jaw or shoulder, shortness of breath, dizziness, severe stomach pain, swelling in your legs, sudden numbness or weakness, headache, or problems with vision or speech.

Ponatinib may also harm your liver. Call your doctor right away if you have upper stomach pain with loss of appetite, dark urine, bruising, or yellowing of your skin or eyes.

Before taking this medicine

You should not use ponatinib if you are allergic to it.

Tell your doctor if you have ever had:

You may need to have a negative pregnancy test before starting this treatment.

Ponatinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using ponatinib and for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because ponatinib can harm an unborn baby.

You should not breast-feed while using ponatinib and for at least 6 days after your last dose.

How should I take ponatinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ponatinib is usually taken once daily, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using ponatinib. You may need to stop using the medicine at least 1 week before a surgery.

Do not stop taking ponatinib or change your medication dose without your doctor's advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ponatinib?

Grapefruit may interact with ponatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

ponatinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Ponatinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ponatinib may cause heart or blood vessel problems that could lead to heart attack or stroke. Call your doctor right away or get emergency medical help if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, feeling short of breath;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

  • signs of a blood clot--severe stomach pain, pain or swelling in your arms or legs, coughing up blood.

Call your doctor at once if you have:

  • chest pain, shortness of breath, pounding heartbeats, fluttering in your chest;

  • dizziness, confusion, headache, change in mental status;

  • severe pain in your upper stomach, loss of appetite, nausea and vomiting;

  • dark urine, bruising, jaundice (yellowing of the skin or eyes);

  • vision problems, eye pain or swelling, bleeding in the eye, increased sensitivity to light, flashes of light or "floaters" in your vision;

  • a seizure;

  • nosebleeds, bloody or tarry stools, pink or brown urine, heavy menstrual periods, vomit that is bloody or looks like coffee grounds;

  • muscle cramps or weakness, trouble moving your eyes or other parts of your face;

  • swelling or rapid weight gain; or

  • numbness, burning pain, tingling in your hands and feet or around your mouth.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ponatinib dosing information

Usual Adult Dose for Chronic Myelogenous Leukemia:

Initial Dose: 45 mg orally once a day

Comments: The optimal dose has not been identified. The starting dose in clinical trials was 45 mg once a day; however, 68% of phase 2 trial patients required dose reductions to 30 mg or 15 mg once a day.

Uses: Treatment of:
-Chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
-T315I-positive CP/AP/BP CML or T315I-Ph+ ALL

What other drugs will affect ponatinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect ponatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.