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Drugs & Medications

Iclusig

GENERIC NAME(S): PONATINIB HCL

WARNINGS:

Ponatinib has caused serious (sometimes fatal) blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). 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 unusual tiredness, swelling ankles/feet.

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 immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin. Your doctor may need to change your dosage or discontinue the drug.

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Uses

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.

The U.S. Food and Drug Administration (FDA) has asked the manufacturer to stop marketing and selling ponatinib because of the risk of serious blood clots (see Warning section). If you are responding to ponatinib treatment and your doctor feels this outweighs the risks of using ponatinib, then your doctor can get permission from the FDA to continue treatment with ponatinib. It is important to talk to your doctor about the risks of treatment with ponatinib.

How to use Iclusig

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, 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.

Side Effects

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 promptly.

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, swelling of legs/ankles, persistent nausea/vomiting, numb/tingling skin, pain/numbness/burning feeling in fingers/toes, fainting, fast/slow/irregular/pounding heartbeat, eye pain/swelling/irritation, blurred vision, change in the amount of urine.

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.

This medication may increase your blood pressure. Check your blood pressure regularly and tell your doctor of any high results.

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).

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

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).

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.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

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 carbamazepine, phenytoin), St. John's wort, among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

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.

Missed Dose

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

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.

MEDICAL ALERT: 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).

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Images

ICLUSIG 15 MG TABLET
ICLUSIG 15 MG TABLET
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A5
ICLUSIG 45 MG TABLET
ICLUSIG 45 MG TABLET
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AP4
ICLUSIG 15 MG TABLET
ICLUSIG 15 MG TABLET

Identification

color
white
shape
round
imprint
A5
This medicine is a white, round, film-coated tablet imprinted with "A5".
ICLUSIG 45 MG TABLET
ICLUSIG 45 MG TABLET

Identification

color
white
shape
round
imprint
AP4
This medicine is a white, round, film-coated tablet imprinted with "AP4".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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