Ponatinib may cause serious or life-threatening blood clots in your legs or lungs, heart attacks, or strokes. Tell your doctor if you have or have ever had a blood clot in your lungs or legs; a stroke; high blood pressure; hyperlipidemia (high levels of cholesterol in your blood); a slow, fast, or irregular heartbeat; peripheral vascular disease (narrowing of blood vessels in feet, legs, or arms causing numbness, pain, or coldness in that part of the body); a heart attack; or heart disease. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; dizziness or fainting; sudden confusion or trouble speaking or understanding; sudden numbness or weakness of face, arm, or leg on one side of the body; sudden severe headache; leg, arm, back, neck, or jaw pain; feeling of warmth in the lower leg; or swelling of the feet, ankles, or lower legs.
Ponatinib may cause serious or life-threatening heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) and arrhythmias (abnormal heart rhythms). Tell your doctor if you have or have ever had heart problems, including heart failure, QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); or a slow, fast, or irregular heartbeat. If you experience any of the following symptoms, call your doctor immediately: shortness of breath; chest pain; fast, irregular, or pounding heartbeat; dizziness; or fainting.
Ponatinib may cause serious or life-threatening damage to the liver. Tell your doctor if you have or have ever had liver disease or problems with your liver. If you experience any of the following symptoms, call your doctor immediately: itching, yellow eyes or skin, dark urine, or pain or discomfort in the right upper stomach area.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before you start and during your treatment to check your body's response to ponatinib.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ponatinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Ponatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells), including treatment in people who can no longer benefit from other medications for CML or who cannot take these medications because of side effects. Ponatinib is also used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in people who can no longer benefit from other medications for leukemia or who cannot take these medications because of side effects. Ponatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Ponatinib comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take ponatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ponatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor may need to delay your treatment, adjust your dose, or permanently stop your treatment of ponatinib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take ponatinib even if you feel well. Do not stop taking ponatinib without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking ponatinib,
Do not eat large amounts of grapefruit or drink grapefruit juice while taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Ponatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking ponatinib and call your doctor immediately or get emergency medical treatment:
Ponatinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2018.