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.
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.
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, other medications you may be taking, and response to treatment.
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.
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: weight gain, numb/tingling skin, pain/numbness/burning feeling in fingers/toes, fainting, fast/slow/irregular/pounding heartbeat, eye pain/swelling/irritation, blurred vision/vision problems, problems thinking.
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: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.
Get medical help right away if you have any very serious side effects, including: unusual bleeding/bruising, black/bloody stools, vomit that contains blood or looks like coffee grounds, shortness of breath, seizures.
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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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: liver disease, heart problems (such as history of heart attack, angina, high blood pressure), previous stroke or "mini-stroke" (transient ischemic attack), diabetes, high cholesterol, tobacco use.
This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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.
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.
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 themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
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.Information last revised February 2017. Copyright(c) 2017 First Databank, Inc.
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