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Iclusig

Generic Name: ponatinib (poe NA ti nib)
Brand Names: Iclusig

What is Iclusig?

Iclusig (ponatinib) is a cancer medicine that interferes with the growth of some cancer cells.

Iclusig is used to treat a type of blood cancer called chronic myeloid leukemia (CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).

Iclusig is usually given after other similar medications have been tried without success.

Important information

Iclusig may cause heart or blood vessel problems that could lead to heart attack or stroke.

Call your doctor or get emergency medical help if you have: chest pain spreading to your jaw or shoulder, shortness of breath, sudden numbness or weakness, severe headache, severe dizziness, or problems with vision or speech.

Iclusig may also harm your liver. Call your doctor right away if you have upper stomach pain with loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Iclusig if you are allergic to ponatinib.

To make sure Iclusig is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, heart rhythm problems;

  • a history of stroke or blood clot;

  • diabetes;

  • a history of high cholesterol;

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • a history of pancreatitis;

  • a history of stomach or intestinal bleeding; or

  • lactose intolerance (tablets may contain lactose).

Using Iclusig during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine. Use effective birth control to prevent pregnancy during treatment with Iclusig.

It is not known whether ponatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Iclusig is not approved for use by anyone younger than 18 years old.

How should I take Iclusig?

Iclusig is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, break, or dissolve a Iclusig tablet. Swallow it whole.

You may take Iclusig with or without food.

You may need frequent medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using Iclusig. You may need to stop using the medicine at least 1 week before a surgery.

Do not stop taking Iclusig or change your medication dose without your doctor's advice.

Store at room temperature away from moisture and heat.

Iclusig dosing information

Usual Adult Dose for Chronic Myelogenous Leukemia:

45 mg orally once daily

Comments:
-Iclusig may be taken with or without food and tablets should be swallowed whole.
-59% of patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy.
-Consider reducing the dose for CP CML and AP CML patients who have achieved a major cytogenetic response.
-Consider discontinuing therapy if response has not occurred by 3 months (90 days).

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Iclusig?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Grapefruit and grapefruit juice may interact with ponatinib and lead to unwanted side effects. Avoid drinking grapefruit juice while taking this medication.

Iclusig side effects

Get emergency medical help if you have signs of an allergic reaction to Iclusig: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Iclusig may cause heart or blood vessel problems that could lead to heart attack or stroke. Call your doctor right away or get emergency medical help if you have:

  • heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, feeling short of breath;

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

  • signs of a blood clot - severe stomach pain, pain or swelling in your arms or legs, coughing up blood.

Call your doctor at once if you have:

  • numbness, tingling, or burning pain in your hands or feet;

  • drooping eyelids, trouble moving your eyes or other parts of your face;

  • eye pain or itching, dry eyes, and seeing flashes of light or "floaters" in your vision;

  • severe stomach pain or swelling;

  • fever, flu symptoms;

  • dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears, severe chest pain, shortness of breath;

  • fluid retention - cough, shortness of breath, swelling, rapid weight gain;

  • pancreas problems - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • severe bleeding - nosebleeds, bloody or tarry stools, pink or brown urine, heavy menstrual periods, vomit that is bloody or looks like coffee grounds; or

  • signs of tumor cell breakdown - lower back pain, blood in your urine, little or no urination; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common Iclusig side effects may include:

  • dry skin, mild skin rash;

  • stomach pain, nausea, constipation;

  • fever;

  • tired feeling; or

  • headache, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Iclusig?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • imatinib;

  • nefazodone;

  • St. John's wort;

  • an antibiotic - clarithromycin, telithromycin;

  • antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;

  • heart or blood pressure medicine - nicardipine, quinidine;

  • antiviral medicine to treat hepatitis or HIV/AIDS - atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;

  • seizure medicine - carbamazepine, phenytoin; or

  • tuberculosis medicine - isoniazid, rifampin.

This list is not complete. Other drugs may interact with ponatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Iclusig.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Iclusig only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 3.02. Revision Date: 2016-02-09, 3:57:14 PM.

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