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Ponatinib Oral Tablet (PONATINIB - ORAL)

For treating cancer.

Brand Name(s): Iclusig

Generic Name: Ponatinib

Instructions

Swallow the medicine without crushing or chewing it.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Drink plenty of water while on this medicine.

Avoid grapefruit juice while on this medicine.

Medicines that lower stomach acid (used to treat indigestion, heartburn or ulcers) may prevent this medicine from working properly.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 6 days after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 3 weeks after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • decreased appetite
  • constipation
  • dizziness
  • headaches

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • back pain
  • bleeding or bruising
  • chest or jaw pain
  • cough that does not go away
  • coughing up blood or vomit that looks like coffee grounds
  • swelling of the legs, feet, and hands
  • pain in the eye
  • fainting
  • fever or chills
  • numbness or tingling in hands and feet
  • fast, irregular, or slow heartbeat
  • high blood pressure
  • signs of kidney damage (such as change in urine color or bubbly urine)
  • sudden leg pain, swelling, warmth or redness
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • muscle weakness
  • seizures
  • shortness of breath
  • dark, tarry stool
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
  • blurring or changes of vision
  • sudden or unexplained weight gain
  • slow wound healing

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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