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Ponatinib

Ponatinib (Iclusig) is a targeted cancer medicine used to treat certain types of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

Brand name Iclusig
Drug classes Kinase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Ponatinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ponatinib (Iclusig), on the market since about 2012, is a specialist drug for two adult leukemias (CML and Ph+ ALL), working by blocking BCR::ABL, the faulty protein behind them, even its T315I mutant form that defeats similar drugs, and outside newly diagnosed Ph+ ALL it is usually saved for when other options fail. It is tougher to tolerate than related leukemia drugs, with rash, joint pain, belly pain and rising blood pressure the common complaints. Its boxed warning covers artery blockages (heart attack, stroke), vein clots, heart failure and liver damage, even in people under 50, so chest pain, one-sided weakness, leg swelling or sudden breathlessness means emergency care.

Clinical pearls

  • Swallow it whole, never crushed or chewed; a missed dose is simply skipped, with the next taken at the usual time.
  • Expect regular blood pressure checks and liver blood tests, since rising pressure and liver damage are both known risks with ponatinib.
  • Strong CYP3A (liver enzyme) blockers like ketoconazole raise its levels and inducers like rifampin lower them, so screen every new prescription.
  • Tell any surgeon you take it, because Iclusig is paused before and after surgery so wounds can heal properly.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Iclusig carries a Boxed Warning — the most serious type of FDA warning — for four life-threatening risks:

  • Arterial blockages (heart attack, stroke, severe limb artery disease): These have been fatal. They can happen even in patients without known heart disease, including those 50 years old or younger. Your doctor must monitor you closely and may stop or adjust your dose if one occurs.
  • Vein blood clots (venous thromboembolic events): Serious clots in the veins — such as deep vein thrombosis (leg clots) or pulmonary embolism (lung clots) — have occurred. Report any sudden leg swelling, pain, or breathing difficulty immediately.
  • Heart failure: Serious and sometimes fatal heart failure has occurred. Contact your doctor right away if you feel short of breath, your legs swell, or you gain weight rapidly.
  • Liver damage (hepatotoxicity): Serious liver damage, including liver failure and death, has occurred. Liver function will be tested regularly. Report yellowing of the skin or eyes, dark urine, or severe fatigue immediately.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2012
Companies listing it with the FDA1
FDA label last updatedAug 14, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Ponatinib, written from its FDA label.

What Ponatinib is used for

▾

Ponatinib (Iclusig) is a targeted cancer medicine approved for specific types of leukemia in adults. Depending on the situation, it may be used alone or combined with chemotherapy.

  • Iclusig is used for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy — this approval is based on early response data and may be confirmed by further studies
  • Iclusig is used as monotherapy (on its own) in Ph+ ALL for patients who cannot receive any other kinase inhibitor therapy, or who have the T315I mutation
  • Iclusig is used for chronic phase CML (CP-CML) that is resistant to or not tolerated by at least two prior kinase inhibitors
  • Iclusig is used for accelerated phase (AP) or blast phase (BP) CML when no other kinase inhibitors are appropriate
  • Iclusig is used for T315I-positive CML in any phase (chronic, accelerated, or blast)
  • Iclusig is not indicated or recommended for newly diagnosed chronic phase CML

How Ponatinib works

▾

Ponatinib is a kinase inhibitor — it works by blocking a faulty signaling protein called BCR::ABL that leukemia cells in CML and Ph+ ALL depend on to grow and survive. By blocking this protein, ponatinib cuts off the instructions cancer cells need to keep dividing. It also blocks several other related proteins (including members of the VEGFR, PDGFR, FGFR, and SRC kinase families) that may contribute to cancer growth.

Ponatinib was specifically engineered to remain effective even against the T315I mutation — a change in the BCR::ABL protein that makes most other kinase inhibitors stop working. This makes it a valuable option when other targeted therapies have failed.

Ponatinib dosage

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Iclusig tablets are taken by mouth once daily and can be taken with or without food. Tablets must be swallowed whole — do not crush, cut, break, or chew them. If you miss a dose, skip it and take the next one at your usual time the following day.

  • For newly diagnosed Ph+ ALL, Iclusig is started at one dose in combination with chemotherapy, then reduced when a good response is achieved
  • For CP-CML, the dose may also be stepped down once a target response is reached, and can be increased again if the response is lost
  • Your doctor will adjust the dose based on how you respond and any side effects — this is expected and normal

Dosing details from the FDA-approved label

From the Ponatinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Newly Diagnosed Ph+ ALL (in combination with chemotherapy)
    • 30 mg orally once daily, with a reduction to 15 mg orally once daily upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction
    • Continue in combination with chemotherapy for up to 20 cycles until loss of response or unacceptable toxicity
    • No dosage adjustment for mild hepatic impairment (Child-Pugh A); closely monitor moderate or severe hepatic impairment (Child-Pugh B or C). May be taken with or without food.
  • Monotherapy for Ph+ ALL for Whom No Other Kinase Inhibitors Are Indicated or T315I-positive Ph+ ALL
    • 45 mg orally once daily
    • Continue until loss of response or unacceptable toxicity
    • Consider discontinuing if response has not occurred by 3 months
    • Reduce starting dose to 30 mg orally once daily in pre-existing hepatic impairment (Child-Pugh A, B, or C). The optimal dose has not been identified.
  • CP-CML
    • 45 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of ≤1% BCR::ABL1 IS
    • Patients with loss of response can re-escalate to a previously tolerated dosage of 30 mg or 45 mg orally once daily
    • Consider discontinuing if hematologic response has not occurred by 3 months
    • Reduce starting dose to 30 mg orally once daily in pre-existing hepatic impairment (Child-Pugh A, B, or C).
  • AP-CML and BP-CML
    • 45 mg orally once daily
    • Continue until loss of response or unacceptable toxicity
    • Consider discontinuing if response has not occurred by 3 months
    • Consider reducing the dose for AP-CML patients who have achieved a major cytogenetic response
    • Reduce starting dose to 30 mg orally once daily in pre-existing hepatic impairment (Child-Pugh A, B, or C). The optimal dose has not been identified.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended Dosage in Newly Diagnosed Ph+ ALL : Starting dose is 30 mg orally once daily in combination with chemotherapy, with a reduction to 15 mg once daily upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction. ( 2.1 ) Recommended Dosage in Monotherapy for Ph+ ALL for Whom No Other Kinase Inhibitors are Indicated or T315I-positive Ph+ ALL : Starting dose is 45 mg orally once daily. ( 2.1 ) Recommended Dosage in CP-CML : Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR::ABL1 IS . ( 2.1 ) Recommended Dosage in AP-CML and BP-CML : Starting dose is 45 mg orally once daily. ( 2.1 ) Hepatic Impairment : See the Full Prescribing Information for dosage modifications for hepatic impairment. ( 2.4 ) ICLUSIG may be taken with or without food. ( 2.1 ) 2.1 Recommended Dosage Newly Diagnosed Ph+ ALL The recommended starting dosage of ICLUSIG in combination with chemotherapy is 30 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction. Continue ICLUSIG in combination with chemotherapy for up to 20 cycles until loss of response or unacceptable toxicity [see Clinical Studies (14) ] . For a description of dosing of agents administered in combination with ICLUSIG, [see Clinical Studies (14) ] . Monotherapy for Ph+ ALL for Whom No Other Kinase Inhibitors Are Indicated or T315I-positive Ph+ ALL The optimal dose of ICLUSIG has not been identified. The recommended starting dosage of ICLUSIG is 45 mg orally once daily. Continue ICLUSIG until loss of response or unacceptable toxicity. Consider discontinuing ICLUSIG if response has not occurred by 3 months. CP-CML The recommended starting dosage of ICLUSIG is 45 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of ≤1% BCR::ABL1 IS . Patients with loss of response can re-escalate the dose of ICLUSIG to a previously tolerated dosage of 30 mg or 45 mg orally once daily. Continue ICLUSIG until loss of response at the re-escalated dose or unacceptable toxicity. Consider discontinuing ICLUSIG if hematologic response has not occurred by 3 months. AP-CML and BP-CML The optimal dose of ICLUSIG has not been identified. The recommended starting dosage of ICLUSIG is 45 mg orally once daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ponatinib side effects

▾

The most common side effects reported with Iclusig include:

Common side effects

  • Rash and skin reactions
  • Joint pain (arthralgia)
  • Abdominal pain
  • Fatigue
  • Headache
  • High blood pressure (hypertension)
  • Nausea
  • Constipation
  • Dry skin
  • Fluid retention or swelling
  • Low blood cell counts (which can increase infection and bleeding risk)

When to get medical help

  • Call your doctor right away if you have chest pain, sudden shortness of breath, or weakness on one side — these may be signs of a heart attack or stroke.
  • Get medical help immediately if you notice leg swelling, redness, or warmth that could indicate a blood clot (deep vein thrombosis or pulmonary embolism).
  • Tell your doctor right away if you develop signs of heart failure, such as swelling in your legs, rapid weight gain, or difficulty breathing.
  • Contact your doctor if you notice yellowing of the skin or eyes, dark urine, or severe fatigue — these may signal liver damage (hepatotoxicity).
  • Report severe abdominal pain, especially with nausea or vomiting — this may be a sign of pancreatitis (inflammation of the pancreas).
  • Seek immediate care if you experience sudden vision changes, severe headache, or confusion, which could indicate a serious brain condition called RPLS (reversible posterior leukoencephalopathy syndrome).
  • Tell your doctor about any unusual bleeding, signs of infection (fever, chills), or significantly reduced urination.

Ponatinib warnings and precautions

▾
  • Arterial blockages (heart attack, stroke, severe limb artery disease): These can be fatal and can occur even in younger patients without known heart disease. Older patients and those with high blood pressure, diabetes, or high cholesterol are at greatest risk.
  • Vein blood clots: Deep vein thrombosis (leg clots), pulmonary embolism (lung clots), and other vein clots have occurred — some serious.
  • Heart failure: Serious and fatal cases have been reported. Watch for swelling, rapid weight gain, or new breathing difficulty.
  • Liver damage (hepatotoxicity): Liver failure and death have occurred. Liver tests are checked regularly throughout treatment.
  • High blood pressure: Serious hypertension, including hypertensive crisis, has been reported and requires monitoring and management.
  • Pancreatitis: Inflamed pancreas (causing severe abdominal pain) has occurred — lipase levels are monitored during treatment.
  • Low blood counts (myelosuppression): Iclusig can cause drops in white blood cells, red blood cells, and platelets, increasing infection and bleeding risk.
  • Other risks to watch for: Nerve damage (neuropathy), eye problems, bleeding, fluid retention, abnormal heart rhythms, wound healing problems, tumor lysis syndrome, and a rare but serious brain condition called RPLS.
  • Embryo-fetal toxicity: Iclusig can cause serious harm to an unborn baby. Effective contraception is required during treatment.

Ponatinib interactions

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Ponatinib is processed by liver enzymes (primarily CYP3A4), so medicines that affect these enzymes can change how much ponatinib is in your body:

  • Strong CYP3A inhibitors (e.g., certain antifungals like ketoconazole): Raise ponatinib blood levels significantly, increasing the risk of side effects — avoid combining, or reduce the Iclusig dose if combination is unavoidable
  • Strong CYP3A inducers (e.g., rifampin, an antibiotic): Lower ponatinib levels substantially, which could make it less effective — avoid combining unless benefits clearly outweigh the risk
  • Acid-reducing medicines (e.g., proton pump inhibitors like lansoprazole): Can modestly reduce how much ponatinib is absorbed into the bloodstream

Interactions listed in the FDA-approved label

From the Ponatinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inhibitors: Coadministration increases ponatinib plasma concentrations, which may increase the risk of ICLUSIG adverse reactions. Avoid coadministration. If it cannot be avoided, reduce the ICLUSIG dosage (45 mg to 30 mg, 30 mg to 15 mg, 15 mg to 10 mg once daily; avoid coadministration with a strong CYP3A inhibitor at 10 mg once daily). After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the previously tolerated ICLUSIG dosage.
  • Strong CYP3A inducers: Coadministration decreases ponatinib plasma concentrations. Avoid coadministration unless the benefit outweighs the risk of decreased ponatinib exposure. Monitor patients for reduced efficacy. Selection of concomitant medication with no or minimal CYP3A induction potential is recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A Inhibitors : Avoid coadministration or reduce ICLUSIG dose if coadministration cannot be avoided. ( 2.3 , 7.1 ) Strong CYP3A Inducers : Avoid coadministration. ( 7.1 ) 7.1 Effects of Other Drugs on ICLUSIG Strong CYP3A Inhibitors Coadministration of ICLUSIG with a strong CYP3A inhibitor increases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of ICLUSIG adverse reactions. Avoid coadministration of ICLUSIG with strong CYP3A inhibitors. If coadministration of ICLUSIG with strong CYP3A inhibitors cannot be avoided, reduce the ICLUSIG dosage [see Dosage and Administration (2.3) ] . Strong CYP3A Inducers Coadministration of ICLUSIG with a strong CYP3A inducer decreases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] . Avoid coadministration of ICLUSIG with strong CYP3A inducers unless the benefit outweighs the risk of decreased ponatinib exposure. Monitor patients for reduced efficacy. Selection of concomitant medication with no or minimal CYP3A induction potential is recommended.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿168 supplements and herbs with documented Ponatinib interactions, ranked by severity Check Ponatinib against a supplement or herb →

Before taking Ponatinib

▾
  • Heart or vascular disease history: People with high blood pressure, diabetes, high cholesterol, prior heart attack, stroke, or blood clots face a higher risk of serious vascular events — discuss fully with your doctor
  • Liver problems: Pre-existing liver disease may require a lower starting dose of Iclusig; more frequent monitoring is needed
  • Severe kidney disease: Iclusig has not been studied in patients with severe kidney impairment — talk to your doctor
  • Pregnancy: Iclusig can cause serious harm to an unborn baby — a pregnancy test is required before starting, and effective contraception must be used during treatment and for 3 weeks after the last dose
  • Breastfeeding: Do not breastfeed while taking Iclusig or for 1 week after the last dose
  • Fertility: Based on animal data, Iclusig may affect fertility in women — speak with your doctor if this is a concern
  • Children and teenagers: Safety and effectiveness have not been established in patients under 18
  • Older adults (65+): Higher risk of blood vessel blockages, low platelet counts, fluid retention, and other side effects — careful dose selection and closer monitoring are recommended
  • Upcoming surgery: Iclusig should be paused before elective surgery and not restarted until wounds have healed adequately

Ponatinib overdose

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Overdoses of Iclusig have occurred in clinical trials and can cause serious problems including heart rhythm changes (QT prolongation), fatigue, chest pain, infection, and dangerous fluid around the heart. If an overdose is suspected, Iclusig should be stopped immediately and the patient should receive supportive medical care. Contact emergency services or a poison control center right away.

What Ponatinib does in the body

▾

At higher doses of ponatinib, there is a greater chance of serious side effects — including high blood pressure, low platelet counts, pancreatitis, and low white blood cell counts. The risk of arterial blockage events is also higher with greater drug exposure and is further increased by older age and existing conditions such as high blood pressure, diabetes, and high cholesterol. At doses studied (30 to 60 mg), ponatinib did not cause a large or clinically concerning change in the heart's electrical rhythm (QTc interval), so major heart rhythm concern from this effect appears low at approved doses.

How your body processes Ponatinib

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After taking an Iclusig tablet by mouth, peak drug levels are reached within about 6 hours, and the drug can be taken with or without food since food does not meaningfully affect absorption. Ponatinib is very tightly bound to proteins in the blood (more than 99%), spreads widely throughout the body, and has a half-life of roughly 24 hours — meaning it takes about a day for the body to clear half of the drug. It is broken down mainly by the liver (primarily through an enzyme called CYP3A4) and is eliminated mostly through the stool, with a small amount leaving through the urine.

How to store Ponatinib

▾

Store ICLUSIG tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

168

Supplements & herbs that interact with Ponatinib

168 supplements and herbal products have documented interactions with Ponatinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 124
  • Minor · 38
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +160 more
Every supplement checked against Ponatinib — ranked by severity The full interaction hub: 6 major · 124 moderate · 38 minor · every one linked to its full report. Check Ponatinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ponatinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ponatinib — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Iclusig used for? My doctor mentioned leukemia, but there seem to be different types.

▾
Iclusig (ponatinib) is used to treat specific types of leukemia in adults — mainly chronic myeloid leukemia (CML) and a type called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It's often prescribed when other targeted treatments have stopped working, aren't tolerated, or when a specific gene mutation called T315I is present. For newly diagnosed Ph+ ALL, it's used in combination with chemotherapy. Your doctor chose it because it's one of the few medicines that can tackle that tricky T315I mutation.

Can I take Iclusig with food? Does it matter when I take it?

▾
Good news — you can take Iclusig with or without food, whichever works best for you. It's taken once a day, and studies show that meals don't meaningfully change how much of the medicine gets into your body. Try to take it around the same time each day to keep levels consistent. If you ever miss a dose, just skip it and take your next one at the usual time tomorrow — never double up.

I've heard this medicine can cause heart problems. How serious is that, and what should I watch out for?

▾
This is one of the most important things to know about Iclusig, and it's worth taking seriously. It can cause blockages in arteries — including heart attack and stroke — as well as blood clots in veins and heart failure. These have happened even in people without known heart disease. Call your doctor right away or go to the ER if you have chest pain, sudden weakness or numbness, trouble speaking, severe leg swelling, or shortness of breath. Your doctor will monitor your blood pressure and heart regularly, so keep all your appointments.

What side effects should I just expect to deal with, versus which ones mean I need to call my doctor?

▾
Everyday side effects you might notice include rash, joint aches, stomach pain, headache, fatigue, constipation, or nausea — these are common and your care team can often help manage them. High blood pressure is also very common, so your blood pressure will be checked regularly. The ones to call your doctor about right away: chest pain, difficulty breathing, sudden leg swelling or redness, yellowing of your skin or eyes, severe stomach pain, or any unusual bleeding. These could signal something serious that needs prompt attention.

Are there any medicines or supplements I need to avoid while I'm on Iclusig?

▾
Yes — this is important to mention to every provider you see. Certain antifungal medications (like ketoconazole) and some antibiotics (like rifampin) can either raise or lower the amount of Iclusig in your blood, which affects both how well it works and your risk of side effects. Even some common acid reflux medicines (like proton pump inhibitors) can affect absorption. Always tell every doctor, dentist, or pharmacist that you're on Iclusig before starting anything new — including over-the-counter medicines and supplements.

Is it safe to get pregnant or breastfeed while taking Iclusig?

▾
Iclusig can cause serious harm to an unborn baby, so pregnancy must be avoided during treatment. If you're a woman who could become pregnant, you'll need to use reliable birth control while taking Iclusig and for 3 weeks after your last dose. A pregnancy test is done before you start the medicine. Breastfeeding is also not safe during treatment — the recommendation is to avoid it while on Iclusig and for 1 week after your last dose. If you have questions or concerns about family planning, bring them up with your oncologist.

Is Ponatinib available over the counter?

▾
No. Ponatinib is a prescription medicine: every Ponatinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ponatinib first available?

▾
The earliest FDA record we hold for Ponatinib is from 2012: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ponatinib was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ponatinib on HelloPharmacist

📊Ponatinib supplement interactions168 checked — ranked by severity 🌿Drug & Supplement CheckerPonatinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ponatinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ponatinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ponatinib forms and strengths (how it comes)

Ponatinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ponatinib inactive ingredients by manufacturer.

Tablet

By mouth
Brands Iclusig
How this form is used
What it may be used for
  • Iclusig tablets are used to treat adults with newly diagnosed Ph+ ALL in combination with chemotherapy
  • Iclusig tablets are used as monotherapy in Ph+ ALL for patients who cannot take other kinase inhibitors, or who have the T315I mutation
  • Iclusig tablets are used to treat chronic phase CML that has not responded to at least two prior kinase inhibitors
  • Iclusig tablets are used to treat accelerated phase or blast phase CML, or T315I-positive CML, when no other kinase inhibitors are appropriate
Important instructions
  • Iclusig tablets may be taken with or without food
  • Swallow Iclusig tablets whole — do not crush, break, cut, or chew them
  • Iclusig is taken once daily; if a dose is missed, take the next dose at the regular scheduled time the next day — do not double up
  • Iclusig dose may be reduced based on your response to treatment or side effects — follow your prescriber's instructions exactly
Available strengths 4 strengths
10 mg 15 mg 30 mg 45 mg
12 FDA-listed product records ⓘ

Ponatinib on the U.S. market: products, makers and brands

How Ponatinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 4 Ponatinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2012. Brand names on the directory include Iclusig; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
4
FDA-listed product records ⓘ
2012
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Ponatinib is used (Medicaid data)

A general measure of how commonly Ponatinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ponatinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,562
Medicaid prescriptions filled (Q1–Q4 2025)
$57.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ponatinib prescribed? Of the 1,601 medications we measure, Ponatinib ranks #1,155 by Medicaid prescriptions — more than 28% of them.

Where Ponatinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,155 of 1,601
#1,150 Prasterone Vaginal 2,624 Rx #1,151 Mifepristone (Mifeprex... 2,590 Rx #1,152 Mifepristone (Korlym) 2,590 Rx #1,153 Deferiprone 2,586 Rx #1,154 Calcifediol 2,586 Rx #1,155 Ponatinib 2,562 Rx #1,156 Lanadelumab-flyo injec... 2,560 Rx #1,157 Tafluprost Ophthalmic 2,553 Rx #1,158 Cytarabine 2,537 Rx #1,159 Arsenic Trioxide Injec... 2,519 Rx #1,160 Arsenic Trioxide 2,519 Rx

Utilization by Ponatinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 15 mg oral tablet is the most-dispensed Ponatinib product — about 67% of these Medicaid prescriptions.

ponatinib 15 MG Oral Tablet Most dispensed

1,711 Medicaid prescriptions (Q1–Q4 2025) 67% of Ponatinib prescriptions shown $39.3M gross reimbursement (before rebates) ≈ $22,990 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1364352

ponatinib 30 MG Oral Tablet

583 Medicaid prescriptions (Q1–Q4 2025) 23% of Ponatinib prescriptions shown $11.9M gross reimbursement (before rebates) ≈ $20,436 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1726637

ponatinib 45 MG Oral Tablet

224 Medicaid prescriptions (Q1–Q4 2025) 9% of Ponatinib prescriptions shown $4.9M gross reimbursement (before rebates) ≈ $22,054 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1364360

ponatinib 10 MG Oral Tablet

44 Medicaid prescriptions (Q1–Q4 2025) 2% of Ponatinib prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $26,030 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2473040

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ponatinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 5 listed Ponatinib NDCs with Medicaid activity.

Compare Ponatinib products

A representative set of FDA-listed product records for Ponatinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
10 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →
15 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →
30 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →
45 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Ponatinib NDCs →

Ponatinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ponatinib recalls since July 2021.

✅No Ponatinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ponatinib RxCUI 1364347 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1364351 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 2473040 15 MG RxCUI 1364352 30 MG RxCUI 1726637 45 MG RxCUI 1364360

Look up RxCUI 1364347 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Ponatinib brand names

Ponatinib is sold under one brand name in the FDA directory — Iclusig. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Iclusig

Who makes Ponatinib: manufacturers and labelers

One company lists Ponatinib products with the FDA. By number of product records, the largest are Takeda Pharmaceuticals America, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Takeda Pharmaceuticals America, Inc. 4

Ponatinib drug class (RxNorm)

Ponatinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) BCR-ABL tyrosine kinase inhibitors
How it works Protein Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ponatinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 14, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ponatinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ponatinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Takeda Pharmaceuticals America, Inc.
Linked label effective
Aug 14, 2026
Composite sections available
24
Linked SPL Set ID
16d804b6-4957-43ee-b18c-3b36ec37c5ac
Linked SPL Document ID
2034440d-14ab-475e-affc-5261ac3683a6
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →