Ponatinib oral tablets

What is this medication?

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.

COMMON BRAND NAME(S): Iclusig

What should I tell my care team before I take this medication?

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

• bleeding disorders
• blood clots
• diabetes (high blood sugar)
• having or recent surgery
• heart attack
• heart disease
• heart failure
• high blood pressure
• high cholesterol
• irregular heartbeat or rhythm
• liver disease
• pancreatitis
• stroke
• 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 medication?

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 have 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 medication?

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 medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Your vision may be tested before and during use of this medicine. Tell your health care provider right away if you have any change in your eyesight.

Before having surgery, talk to your health care provider to make sure it is ok. This medicine can increase the risk of poor healing of your surgical site or wound. You will need to stop this medicine for 7 days before surgery. After surgery, wait at least 2 weeks before restarting this medicine. Make sure the surgical site or wound is healed enough before restarting this medicine. Talk to your health care provider if questions.

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

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 3 weeks after stopping it. 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 or for 6 days after stopping it.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• blurred vision, dry eyes, eye pain, sensitivity to light
• heartbeat rhythm changes (chest pain; dizziness; irregular heartbeat; feeling faint or lightheaded; falls)
• heart attack (pain or tightness in the chest, back or arms)
• heart failure (trouble breathing; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin)
• pain, tingling, numbness in the hands or feet
• pancreatitis (stomach pain that spreads to your back or gets worse after eating or when touched; fever; nausea; vomiting; fast heartbeat)
• seizures
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

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

• constipation
• dry skin
• joint pain
• nausea
• 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 medication?

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.