Ponatinib Tablets

What is this medication?

PONATINIB (poe NA ti nib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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 disorder
• Blood clots
• Diabetes
• Having or recent surgery
• Heart attack
• Heart disease
• Heart failure
• High blood pressure
• High cholesterol
• Irregular heartbeat or rhythm
• Liver disease
• Pancreatic disease
• Stroke
• An unusual or allergic reaction to ponatinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

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 care team about the use of this medication 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?

• Aliskiren
• Ambrisentan
• Boceprevir
• Certain antibiotics, such as clarithromycin or telithromycin
• Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenytoin
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Colchicine
• Conivaptan
• Dabigatran
• Digoxin
• Everolimus
• Fexofenadine
• Grapefruit juice
• Imatinib
• Indinavir
• Irinotecan
• Lapatinib
• Lopinavir; ritonavir
• Maraviroc
• Methotrexate
• Mitoxantrone
• Nefazodone
• Nelfinavir
• Nilotinib
• Ranolazine
• Rifampin
• Ritonavir
• Rosuvastatin
• Saquinavir
• St. John's wort
• Sulfasalazine
• Telaprevir
• Topotecan

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 care team for regular checks on your progress. Tell your care team 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 medication.

Tell your care team right away if you have any change in your eyesight.

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

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

This medication may increase your risk of getting an infection. Call your care team 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.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 3 weeks after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 3 weeks after the last dose. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication and for 6 days after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Burning, pain, tingling, or color changes in the hands, arms, legs, or feet
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Shortness of breath or trouble breathing
• Stomach pain that is severe, does not go away, or gets worse
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Sudden weight gain
• Swelling of the ankles, hands, or feet
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

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

• Constipation
• Dry skin
• Fatigue
• Headache
• Joint pain
• Nausea
• Stomach 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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.