Ponatinib - oral
Ponatinib - oral
Ponatinib has caused serious (sometimes fatal) blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). Talk to your doctor about the risks and benefits of this medication. Get medical help right away if you develop symptoms of a blood clot, including chest/jaw/left arm pain, confusion, slurred speech, weakness on one side of the body, severe headache, severe dizziness, sudden vision changes, trouble breathing, pain/swelling/redness of arms/legs.
This medication can cause very serious (possibly fatal) heart failure. Tell your doctor right away if you develop symptoms of heart failure, including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.
Ponatinib can also rarely cause very serious (possibly fatal) liver disease. Your doctor will order blood tests to check your liver before you start and while you are taking ponatinib. Tell your doctor right away if you develop symptoms of liver disease, including nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin. Your doctor may need to change your dosage or discontinue the drug.
Ponatinib is used to treat certain types of blood cancer (chronic myelogenous leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.
Read the Medication Guide provided by your pharmacist before you start taking ponatinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow whole. Do not crush or dissolve this medication. Drink plenty of fluids unless otherwise directed by your doctor. The dosage is based on your medical condition, lab results, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Do not increase your dose or take this medication more often than directed. Your condition will not improve any faster, and your risk of side effects will increase.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
Acid-lowering medications for indigestion, heartburn, or ulcers (such as proton pump inhibitors/PPIs, H2 blockers, antacids) may prevent ponatinib from working. Consult your doctor or pharmacist if you are taking any of these medications.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
See also Warning section.
Headache, dizziness, constipation, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist immediately.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including:
Ponatinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:
Get medical help right away if you have any very serious side effects, including:
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.
This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Tell your doctor right away if have any signs of infection (such as fever, chills, persistent sore throat, cough).
For women of childbearing age, ponatinib may affect your ability to have children. Ask your doctor for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking ponatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Older adults may be more sensitive to the side effects of this drug, especially unusual bleeding/bruising, blood clots, swollen legs/ankles, muscle spasms, weakness, loss of appetite.
Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking ponatinib. Ponatinib may harm an unborn baby. Your doctor will do a pregnancy test before you start taking this medication. Ask about reliable forms of birth control while taking this medication and for 3 weeks after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 6 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Other medications can affect the removal of ponatinib from your body, which may affect how ponatinib works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), HIV protease inhibitors (such as lopinavir, ritonavir), rifamycins (such as rifabutin), drugs for seizures (such as phenytoin), St. John's wort, among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as blood pressure, eye exam, liver function tests, complete blood counts, lipase, uric acid) should be performed periodically to monitor your progress or check for side effects. See also Warning section.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised January 2020.
Copyright(c) 2020 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.