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Ponatinib (By mouth)

Ponatinib (poe-NA-ti-nib)

Treats leukemia. This is a cancer medicine. The Iclusig(R) product will no longer be marketed in the United States as of October 31, 2013, but may be available in other countries.

Brand Name(s):


There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to ponatinib, or if you are pregnant.

How to Use This Medicine:


  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
  • Take your medicine as directed.
  • Swallow the tablet whole. Do not crush, break, chew, or dissolve it.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you also use St John's wort, conivaptan (Vaprisol®), medicine to treat hepatitis C (such as boceprevir, telaprevir, Victrelis®), medicine to treat HIV/AIDS (such as atazanavir, indinavir, lopinavir/ritonavir, maraviroc, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Norvir®, Selzentry®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, posaconazole, rifampin, telithromycin, voriconazole, Nizoral®, Rifadin®, Rimactane®), medicine to treat seizures (such as carbamazepine, phenytoin, Dilantin®, Tegretol®), medicine to treat depression (such as nefazodone, Serzone®), or stomach medicine (such as cimetidine, famotidine, lansoprazole, omeprazole, pantoprazole, ranitidine, Aciphex®, Dexilant®, Gaviscon®, Maalox®, Mylanta®, Nexium®, Pepcid®, Prevacid®, Prilosec®, Tagamet®, Zantac®).
  • Tell your doctor if you also use aliskiren (Tekturna®), ambrisentan (Letairis®), colchicine (Tracleer®), dabigatran etexilate (Pradaxa®), digoxin (Lanoxin®), everolimus (Zortress®), fexofenadine (Allegra®), imatinib (Gleevec®), irinotecan (Camptosar®), lapatinib (Tykerb®), methotrexate (Trexall®), mitoxantrone (Novantrone®), nilotinib (Tasigna®), ranolazine (Ranexa®), rosuvastatin (Crestor®), saxagliptin (Onglyza®), sirolimus (Rapamune®), sitagliptin (Januvia®), sulfasalazine (Azulfidine®), tolvaptan (Samsca®), or topotecan (Hycamtin®).
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
  • Make sure your doctor knows if you are breastfeeding, or if you have liver disease, bleeding problems, blood clotting problems, diabetes, heart or blood vessel disease, congestive heart failure, high blood pressure, heart rhythm problems, or a history of a heart attack or stroke. Tell your doctor if you have high uric acid levels, stomach or bowel problems, or a history of pancreas problems or alcohol abuse. Tell your doctor if you are lactose intolerant.
  • This medicine may cause blood clotting problems. Check with your doctor right away if you have chest pain, numbness or weakness in your arm, leg, or on one side of your body, trouble breathing, speech problems, or leg pain or swelling.
  • Check with your doctor right away if you have stomach pain, pale stools or dark urine, loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • Check with your doctor if you are rapidly gaining weight, have chest pain or discomfort, extreme tiredness or weakness, trouble breathing, an uneven heartbeat, or excessive swelling of the hands, wrists, ankles, or feet. These may be symptoms of a heart problem or fluid retention.
  • Pancreatitis may occur. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
  • This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Avoid people who are ill, and wash your hands often. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects.
  • This medicine may cause a serious reaction called tumor lysis syndrome. Call your doctor right away if you have a decrease or change in urine amount, joint pain or swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
  • Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, trouble breathing, coughing up blood
  • Dark urine or pale stools, loss of appetite, pain in your upper stomach, yellow eyes or skin
  • Fast, slow, pounding, or uneven heartbeat
  • Fever, chills, cough, sore throat, and body aches
  • Joint pain or swelling
  • Numbness or weakness in your arm or leg, or on one side of your body
  • Pain in your lower leg (calf)
  • Rapid weight gain, swelling in your hands, ankles, or feet
  • Sudden and severe stomach pain, nausea, vomiting, and lightheadedness
  • Sudden or severe headache, problems with vision, speech, or walking
  • Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

  • Constipation, diarrhea, stomach pain
  • Decreased appetite
  • Mild headache
  • Muscle pain
  • Rash, dry skin
  • Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 4/4/2014

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