Ponatinib Oral tablet

What is this medicine?

PONATINIB (poe NA ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cell from growing. It is used to treat chronic myelogenous leukemia and certain types of acute lymphoblastic leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• diabetes

• heart disease

• high blood pressure

• high cholesterol

• history of blood clots

• history of pancreatitis

• history of stroke

• liver disease

• recent surgery

• smoke tobacco

• an unusual or allergic reaction to ponatinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• aliskiren

• ambrisentan

• boceprevir

• carbamazepine

• clarithromycin

• colchicine

• conivaptan

• dabigatran

• digoxin

• everolimus

• fexofenadine

• grapefruit juice

• imatinib

• indinavir

• irinotecan

• itraconazole

• ketoconazole

• lapatinib

• lopinavir/ritonavir

• maraviroc

• medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole

• methotrexate

• mitoxantrone

• nefazodone

• nelfinavir

• nilotinib

• phenytoin

• posaconazole

• ranolazine

• rifampin

• ritonavir

• rosuvastatin

• saquinavir

• St. John’s Wort

• sulfasalazine

• telaprevir

• telithromycin

• topotecan

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

You may need blood work done while you are taking this medicine.

If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bloody or black, tarry stools

• breathing problems

• changes in vision

• chest pain or palpitations

• confusion, trouble speaking or understanding

• dark urine

• dizziness

• eye pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills

• nausea, vomiting

• pain, swelling, warmth in the leg

• pain, tingling, numbness in the hands or feet

• red or dark-brown urine

• red spots on the skin

• severe headache

• spitting up blood or brown material that looks like coffee grounds

• stomach pain

• sudden numbness or weakness of the face, arm or leg

• swelling in the ankles, feet, hands

• tiredness

• unusual bleeding or bruising

• unusually slow heartbeat

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• joint pain

• muscle pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.