About ICLUSIG® (PONATINIB)

ICLUSIG is not for use to treat people with newly diagnosed chronic phase CML.

ICLUSIG is an option if you are T315I-positive or if there are no other appropriate TKIs for you.

If your doctor thinks that no other TKIs are right for your resistant CML or Ph+ ALL, or that you are T315I-positive, your doctor may decide it’s time for you to consider a different treatment. Your doctor may have made this determination because other TKIs didn’t help you reach your CML treatment milestones.

If so, ICLUSIG may be a treatment option for you.

How patients have responded to ICLUSIG >

What have studies of ICLUSIG® (ponatinib) shown?

In the PACE clinical trial, ICLUSIG was tested in patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) whose disease was resistant or intolerant to their previous tyrosine kinase inhibitor (TKI) therapies.

Most of the more than 400 patients studied in the trial had been treated with at least 2 TKIs. Patients with all phases of CML were included in the trial: chronic phase (CP), accelerated phase (AP), and blast phase (BP), as well as patients with Ph+ ALL.

ICLUSIG was found to be effective in resistant or intolerant chronic phase chronic myeloid leukemia (CP-CML) and Ph+ ALL.*

Response rates below should be balanced against side effects.

In CP-CML patients, the goal of this trial was for patients to have a major cytogenetic response (MCyR), which includes patients having a complete cytogenetic response (CCyR) or partial cytogenetic response.



In Ph+ ALL patients, the goal of this trial was for patients to have a major hematologic response (MaHR), which includes patients having a complete hematologic response (CHR) or no evidence of leukemia.



*Minimum follow-up of 48 months.

The T315I mutation.

This common mutation (change) on the BCR-ABL oncogene (a gene that can cause leukemia) has been linked with resistance to other TKIs. ICLUSIG is shown to be effective in patients with the T315I mutation.

In CP-CML patients with the T315I mutation, 70% who were treated with ICLUSIG in the PACE trial achieved MCyR.


What to be aware of when taking ICLUSIG >

WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT ICLUSIG® (PONATINIB)?

What potential serious side effects should you be aware of?

There are serious side effects that have been associated with ICLUSIG. A more complete discussion of these risks can be found in the Patient Medication Guide.

  • Blood clots or blockage in your blood vessels (arteries and veins)
  • Heart problems, including heart failure, or irregular heartbeat
  • Liver problems

ICLUSIG may cause other serious side effects, including:

  • High blood pressure
  • Inflammation of the pancreas (pancreatitis)
  • Neuropathy
  • Effects on the eye
  • Severe bleeding
  • Fluid retention
  • Irregular heartbeat
  • Low blood cell counts
  • Tumor Lysis Syndrome (TLS)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
  • Possible wound healing problems
  • A tear in your stomach or intestinal wall (perforation)
  • May affect your ability to have children
  • Can harm your unborn baby

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ICLUSIG if you have certain side effects. You should not become pregnant during treatment with ICLUSIG. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ICLUSIG.

Common side effects of ICLUSIG:

You may experience the following most common side effects of ICLUSIG:

  • stomach area (abdomen) pain
  • skin rash
  • constipation
  • headache
  • dry skin
  • tiredness
  • high blood pressure
  • fever
  • joint pain
  • nausea
  • diarrhea
  • increase of a serum protein known as lipase
  • vomiting
  • muscle pain
  • pain in arms, hands, legs, and feet

Get the most out of every visit with your medical team.

Ask questions, be open about your medical history, and establish a clear line of communication. Here are a few tips to help you be prepared to speak with your medical team:

  • Make sure you fully understand your test results and what they mean for your treatment.
  • Ask your medical team about your personal treatment goals.
  • Ask about additional resources and support programs available for patients.
  • Bring a pad of paper and pen to record your discussions with your medical team.
  • Bring a caregiver, family member, or friend with you to medical visits.

Talk to your healthcare provider about side effects.


Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ICLUSIG. For more information, ask your healthcare provider or pharmacist.

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

Find out how dosing works >

ICLUSIG® (Ponatinib) Dosing

How and when to take ICLUSIG.

Take your prescribed dose of ICLUSIG once a day, at about the same time every day. You can take your daily dose with or without food. Please consult with your healthcare provider if you have any questions on how to take ICLUSIG. For a more complete list, reference the Patient Medication Guide.


45 mg

The recommended starting dose of ICLUSIG is 45 mg once daily. This dose comes in tablets stamped AP4.

30 mg

15 mg

If you have hepatic impairment, the recommended starting dose of ICLUSIG is 30 mg once daily. If you take certain medications, your doctor may prescribe a 30 mg dose of ICLUSIG. If you experience certain side effects, your doctor may prescribe you a lower dose of ICLUSIG: Either 30 mg or 15 mg daily. Side effects leading to dose reductions may include:

  • decreased bone marrow activity (low blood cell counts)
  • liver problems
  • inflammation of the pancreas and elevation of lipase (pancreatitis)
  • other adverse reactions you may experience

Patients prescribed a lower dose will receive their ICLUSIG in 15 mg tablets stamped A5.

Daily dose reminders:

  • Take ICLUSIG exactly as your healthcare provider tells you to take it.
  • Swallow ICLUSIG tablets whole. Do not crush or dissolve ICLUSIG tablets.
  • You may take ICLUSIG with or without food.
  • If you miss a dose of ICLUSIG, take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
  • If you take too much ICLUSIG, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I tell my healthcare provider before taking ICLUSIG? If you:

  • have a history of blood clots in your blood vessels (arteries or veins)
  • have heart problems, including heart failure, irregular heartbeats, and QT prolongation
  • have diabetes
  • have a history of high cholesterol
  • have liver problems
  • have had inflammation of your pancreas (pancreatitis)
  • have high blood pressure
  • are pregnant or plan to become pregnant. ICLUSIG can harm your unborn baby. You should not become pregnant while taking ICLUSIG. Tell your healthcare provider right away if you become pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if ICLUSIG passes into your breast milk. You and your healthcare provider should decide if you will take ICLUSIG or breastfeed. You should not do both.
  • have bleeding problems
  • plan to have any surgical procedures
  • are lactose (milk sugar) intolerant. ICLUSIG tablets contain lactose.
  • drink grapefruit juice
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. ICLUSIG and other medicines may affect each other causing side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.