Iclusig, illustration of tablet form (not a photo of the actual pack)

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Iclusig

Ponatinib

Prescription required

$18105.00

15mg · 3 × 30 tablets · 3 months supply

BrandBranded medicine· By Takeda

$6035.00 per month

Strength

How long a supply?

1 month$6035.00 a month
3 months$6035.00 a month
6 months$6035.00 a month
Supplied from Israel

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Annual cost

$72420a year at this pack size

Prescription required

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15mg

30mg

45mg

FDA boxed warningArterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity

Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG.

Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity.

Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity.

Read this with the rest of the clinical information

About Iclusig

Overview

Iclusig (ponatinib) is a prescription kinase inhibitor used to treat certain leukemias in adults. It treats Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with chemotherapy when newly diagnosed, or alone when no other kinase inhibitor is indicated or the leukemia has the T315I mutation. It also treats chronic myeloid leukemia (CML) in the chronic phase after resistance or intolerance to at least two prior kinase inhibitors, in accelerated or blast phases when no other kinase inhibitor is indicated, or in any of these phases when the T315I mutation is present; it is not recommended for newly diagnosed chronic-phase CML. Ponatinib blocks the activity of certain proteins called kinases, including ABL and its T315I-mutated form, and has inhibited the survival of cells containing normal or mutated BCR::ABL in laboratory studies.

What it treats

- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults: with chemotherapy for newly diagnosed disease, or alone when no other kinase inhibitors are indicated or the disease is T315I-positive. Approval for newly diagnosed Ph+ ALL is accelerated, based on complete remission with no detectable minimal residual disease at the end of induction treatment; continued approval may depend on confirmation of clinical benefit. - Chronic myeloid leukemia (CML) in adults: chronic-phase disease resistant to or not tolerated after at least two prior kinase inhibitors; accelerated- or blast-phase disease when no other kinase inhibitors are indicated; or T315I-positive disease in any of these phases. Iclusig is not indicated or recommended for newly diagnosed chronic-phase CML.

Safety information

Side effects

Common side effects of Iclusig include rash, joint pain, stomach pain, tiredness, headache, constipation, high blood pressure, dry skin, fever, nausea, and swelling from fluid retention. When used with chemotherapy, common side effects also include vomiting, mouth inflammation or sores, tingling, and peripheral nerve problems. Contact a doctor promptly about serious side effects, including blocked arteries or blood clots in veins, heart failure, abnormal heart rhythms, liver damage, inflammation of the pancreas, bleeding, high blood pressure, or fluid retention. Nerve damage and eye problems can also occur. Iclusig can reduce blood cell counts, including platelets, white blood cells and red blood cells. Low neutrophil counts with fever are common when it is used with chemotherapy. Blood tests are needed to monitor these effects. Other serious risks include tumour lysis syndrome, reversible posterior leukoencephalopathy syndrome (a brain condition), impaired wound healing, and a hole in the stomach or intestines. Iclusig can also harm an unborn baby.

FDA boxed warning

Arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity

Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG.

Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity.

Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Severe abdominal pain: seek medical attention immediately. - Unusual or heavy bleeding: seek medical attention immediately. - A new or worsening irregular heartbeat: seek medical attention immediately. - New or worsening swelling from fluid buildup: seek medical attention immediately. - Fever, especially if you have low white blood cell counts: seek medical attention immediately.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The FDA label lists no formal contraindications for Iclusig. However, it includes important warnings and monitoring requirements. Conditions requiring caution include high blood pressure, pancreatitis, nerve problems, eye problems, bleeding, fluid retention, abnormal heart rhythms and low blood cell counts. Monitoring includes blood pressure checks, blood tests and comprehensive eye examinations before and during treatment. Side effects may require treatment to be interrupted or stopped by the prescriber. Other warnings include tumor lysis syndrome, reversible posterior leukoencephalopathy syndrome (RPLS), impaired wound healing and gastrointestinal perforation. Adequate hydration and correction of high uric acid levels are needed before treatment. Tell your prescriber about planned surgery, as treatment must be withheld around surgery and until wounds have healed adequately. Iclusig can harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.

Interactions

Tell your doctor about all medicines and supplements you take. Iclusig should not be taken with strong CYP3A inhibitors or strong CYP3A inducers. If a strong CYP3A inhibitor cannot be avoided, your prescriber may need to reduce your Iclusig dose.

Using Iclusig

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] (DailyMed, retrieved 19 September 2026).

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