Ponatinib (poe-NA-ti-nib)

Treats leukemia.

Brand Name(s):

Iclusig

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, chew, or dissolve it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ponatinib works. Tell your doctor if you are using ketoconazole, lansoprazole, or rifampin.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective birth control during treatment and for 3 weeks after your last dose of this medicine.
• Do not breastfeed during treatment and for 1 week after your last dose.
• Tell your doctor if you have liver disease, blood clotting problems, diabetes, heart or blood vessel disease, heart failure, high blood pressure, or a history of a heart attack, stroke, pancreas problems, stomach problems (including fistula, hole), or alcohol abuse. Tell your doctor if you are lactose intolerant.
• This medicine may cause the following problems:
  • Blood clots, which could lead to heart attack or stroke
  • High blood pressure, heart failure, heart rhythm problems, retaining fluid
  • Damage or problems with the liver, pancreas, eyes, nerves, or digestive system
  • Severe bleeding
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
  • Tumor lysis syndrome
  • Slow healing of wounds
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine may become infertile (unable to have children).
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread, trouble breathing, coughing up blood, unusual sweating
• Dark urine or pale stools, loss of appetite, stomach pain, yellow eyes or skin
• Eye pain, trouble seeing, vision changes
• Fast, slow, or uneven heartbeat
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness, fainting, seizures, unusual drowsiness, confusion
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Headache
• Joint or muscle pain or swelling
• Mild skin rash, dry skin
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088