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Kinase inhibitor

Ponatinib (brand name Iclusig) is a kinase inhibitor used to treat certain types of leukemia in adults. It works by blocking specific proteins that help cancer cells grow. Because it can cause serious cardiovascular and liver issues, it requires close medical monitoring.

How it worksPonatinib is a kinase inhibitor that blocks the activity of the BCR-ABL fusion protein and other related proteins that drive the growth of certain leukemia cells.

Brand names:ICLUSIG

Used for
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in adultsChronic Myeloid Leukemia (CML) in the chronic phase (CP)Chronic Myeloid Leukemia (CML) in the accelerated phase (AP) or blast phase (BP)T315I-positive Chronic Myeloid Leukemia (CML)
Conditions
Ph+ ALLCP-CMLAP-CMLBP-CMLT315I-positive CML
Class
Kinase InhibitorAntineoplasticKinase inhibitorHematologicCardiovascularHepaticGastrointestinalNervous

How to take

FormsOral tablet
RoutesOral

The starting dose varies depending on the type of leukemia being treated. For example, newly diagnosed Ph+ ALL often starts at 30 mg once daily, while CP-CML may start at 45 mg once daily. Doses may be reduced if certain clinical milestones are met.

Ponatinib can be taken with or without food.

Key warnings

Ponatinib carries a boxed warning regarding serious risks of arterial blockage (including heart attack and stroke), blood clots, heart failure, and liver toxicity.

  • ·Ponatinib carries a boxed warning regarding serious risks of arterial blockage (including heart attack and stroke), blood clots, heart failure, and liver toxicity.
  • ·Monitor blood pressure for hypertension.
  • ·Watch for signs of pancreatitis through lipase tests.
  • ·Monitor for nerve issues (neuropathy) and eye changes.
  • ·Watch for signs of bleeding or fluid retention.
  • ·Monitor blood counts regularly for low cell levels.

Do not use if

  • ·None listed

Side effects

Common

RashJoint painAbdominal painFatigueHeadacheConstipationDry skinNausea

Serious

  • ·Blood vessel blockage (arterial occlusive events like heart attack or stroke)
  • ·Blood clots (venous thromboembolic events)
  • ·Heart failure
  • ·Liver toxicity (hepatotoxicity)
  • ·High blood pressure (hypertension)
  • ·Pancreatitis
  • ·Nerve damage (neuropathy)
  • ·Eye toxicity
  • ·Bleeding (hemorrhage)
  • ·Fluid retention and swelling
  • ·Heart rhythm problems (arrhythmias)
  • ·Low blood cell counts (myelosuppression)

Seek help if

  • ·Chest pain or signs of stroke
  • ·Severe abdominal pain
  • ·Sudden vision changes
  • ·Unusual bleeding or bruising
  • ·Rapid weight gain or swelling

Interactions

  • ·Avoid or reduce dose when using strong CYP3A inhibitors (which can increase drug levels).
  • ·Avoid using strong CYP3A inducers (which can make the drug less effective).
FoodPonatinib can be taken with or without food.

Special populations

PregnancyPonatinib can cause harm to an unborn baby. Animal studies showed developmental issues at doses near human levels. Pregnant women should be informed of these risks.

PediatricThe safety and effectiveness of Ponatinib in children have not been established.

GeriatricIn clinical studies, Ponatinib was used by patients aged 65 and older. While efficacy was similar to younger patients, older patients experienced a higher rate of arterial blockage events.

Talk to your doctor

Monitor

  • ·Blood pressure
  • ·Serum lipase (pancreatitis)
  • ·Peripheral and cranial neuropathy symptoms
  • ·Eye health
  • ·Signs of bleeding
  • ·Fluid retention
  • ·Heart rhythm
  • ·Complete blood counts

Questions to ask

  • ·What are my cardiovascular risk factors for taking Ponatinib?
  • ·How often will I need blood tests to monitor my cell counts?
  • ·Should I avoid certain foods or supplements while on this drug?
  • ·How will we monitor my liver and pancreas health?

Pharmacokinetics

BioavailabilityExposure increased by approximately 90% (median) between the first dose and steady-state.
MetabolismPrimarily involves CYP3A pathway.

Practical

OverdoseOverdose has occurred in clinical trials, leading to issues like heart rhythm changes. If an overdose is suspected, medical attention is required.

StorageStore at room temperature, between 68°F and 77°F.

Ingredients

Allergens

lactose

Inactive

lactose monohydratemicrocrystalline cellulosesodium starch glycolate (type B)colloidal silicon dioxidemagnesium stearatetalcpolyethylene glycolpolyvinyl alcoholtitanium dioxide

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.