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Ponatinib

Generic Name: Ponatinib (poe NA ti nib)
Brand Name: Iclusig

  • Blood clots have happened with ponatinib. Sometimes, blood clots like heart attack and stroke have been deadly. These effects have happened in people with and without risk factors (including people 50 years old or younger). Call your doctor right away if you have chest, arm, leg, back, neck, or jaw pain or pressure. Call your doctor if you are coughing up blood or have numbness or weakness on 1 side of your body; trouble speaking or thinking; change in balance; change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.
  • Very bad and sometimes deadly heart failure has happened with this medicine. You will need to have your heart checked while you take this drug. Call your doctor right away if you have signs of heart failure like shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Very bad and sometimes deadly liver problems have happened with ponatinib. You will need to have your liver checked while you take this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Uses of Ponatinib:

  • It is used to treat leukemia.

What do I need to tell my doctor BEFORE I take Ponatinib?

  • If you have an allergy to ponatinib or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding. Do not breast-feed while you take ponatinib and for 6 days after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ponatinib?

  • Tell all of your health care providers that you take ponatinib. This includes your doctors, nurses, pharmacists, and dentists.
  • If you are allergic to lactose, talk with the doctor.
  • If you have just been diagnosed with chronic myeloid leukemia (CML), talk with your doctor. A study showed that patients with newly diagnosed CML had more bad side effects with this medicine than with a certain other drug.
  • This medicine may cause eye problems that may lead to loss of eyesight or blindness. Tell your doctor if you have or have ever had eye problems. Call your doctor right away if you have any changes in eyesight.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Very bad and sometimes deadly bleeding problems have happened with ponatinib. Talk with the doctor.
  • High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Holes in the GI (gastrointestinal) tract may rarely happen.
  • Patients with cancer who take ponatinib may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
  • A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this medicine. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
  • If you are 65 or older, use ponatinib with care. You could have more side effects.
  • This medicine may cause fertility problems. This may affect being able to have children. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking ponatinib and for at least 3 weeks after your last dose.
  • If you get pregnant while taking this medicine or within 3 weeks after your last dose, call your doctor right away.

How is this medicine (Ponatinib) best taken?

Use ponatinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Swallow whole. Do not chew, break, or melt.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • This medicine may affect how wounds heal. If you need to have surgery, you may need to stop ponatinib before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your doctor.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your eye pressure and eyesight checked as you have been told by the doctor.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Blue or very pale skin in the arms or legs.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Loss of eyesight.
  • Eye is bothered by bright light.
  • Seeing floaters.
  • Dry eyes.
  • Drooping of part of the face.
  • Chest pain or pressure.
  • A heartbeat that does not feel normal.
  • Fast or slow heartbeat.
  • Dizziness or passing out.
  • Swelling of belly.
  • Very bad belly pain.
  • Mouth irritation or mouth sores.
  • Feeling very tired or weak.
  • Change in taste.
  • Call your doctor right away if you have signs of nerve problems. These may include not being able to handle heat or cold; change in sense of touch; or burning, numbness, tingling, pain, or weakness in the arms, hands, legs, or feet.

What are some other side effects of Ponatinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Dry skin.
  • Belly pain.
  • Loose stools (diarrhea).
  • Nose and throat irritation.
  • Bone, joint, or muscle pain.
  • Back pain.
  • Muscle spasm.
  • Not hungry.
  • Weight loss.
  • Not able to sleep.
  • Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ponatinib?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about ponatinib, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ponatinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ponatinib.

Review Date: November 1, 2017

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