ponatinib

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Pronunciation: poe NA ti nib

Brand: Iclusig

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

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, or jaundice (yellowing of the skin or eyes).

What is ponatinib?

Ponatinib is a cancer medicine that interferes with the growth of some cancer cells.

Ponatinib is used 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 similar medications have been tried without success.

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

What should I discuss with my healthcare provider before taking ponatinib?

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

To make sure ponatinib is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, heart rhythm problems;
  • a history of stroke or blood clot;
  • diabetes;
  • a history of high cholesterol;
  • liver disease;
  • a bleeding or blood-clotting disorder;
  • a history of pancreatitis;
  • a history of stomach or intestinal bleeding; or
  • lactose intolerance (tablets may contain lactose).

Using ponatinib during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine. Use effective birth control to prevent pregnancy during treatment with ponatinib.

It is not known whether ponatinib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using ponatinib and for at least 6 days after your last dose.

Ponatinib is not approved for use by anyone younger than 18 years old.

How should I take ponatinib?

Ponatinib is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, break, or dissolve a ponatinib tablet. Swallow it whole.

You may take ponatinib with or without food.

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

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 missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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?

This medicine 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.

Grapefruit and grapefruit juice may interact with ponatinib and lead to unwanted side effects. Avoid drinking grapefruit juice while taking this medication.

What are the possible side effects of ponatinib?

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:

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • severe stomach pain or swelling;
  • fever, flu symptoms;
  • effects on your eyes --eye pain or itching, swollen eyes, dry eyes, bleeding in the eye, increased sensitivity to light, seeing flashes of light or "floaters" in your vision;
  • nerve problems --muscle weakness, trouble moving your eyes or other parts of your face, double vision, altered sense of taste, numbness, tingling, or burning pain in your hands or feet;
  • dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, severe chest pain, shortness of breath;
  • fluid retention --cough, shortness of breath, swelling, rapid weight gain;
  • pancreas problems --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • severe bleeding --nosebleeds, bloody or tarry stools, pink or brown urine, heavy menstrual periods, vomit that is bloody or looks like coffee grounds; or
  • signs of tumor cell breakdown --lower back pain, blood in your urine, little or no urination; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common side effects may include:

  • dry skin, mild skin rash;
  • stomach pain, nausea, vomiting, diarrhea, constipation;
  • headache, muscle or joint pain;
  • pain in your arms, hands, legs, or feet;
  • increased blood pressure; or
  • fever, tired feeling.

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.

What other drugs will affect ponatinib?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • imatinib;
  • nefazodone;
  • St. John's wort;
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole, posaconazole, voriconazole;
  • heart or blood pressure medicine --nicardipine, quinidine;
  • antiviral medicine to treat hepatitis or HIV/AIDS --atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;
  • seizure medicine --carbamazepine, phenytoin; or
  • tuberculosis medicine --isoniazid, rifampin.

This list is not complete. Other drugs may interact with ponatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about ponatinib.

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.

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