Ponatinix (ponatinib) is a targeted cancer medicine for adults with CML or Ph+ ALL when earlier TKI treatment has stopped working or could not be tolerated. It also works against the T315I mutation.
Ponatinix is used in adults with two types of leukemia, when earlier tyrosine kinase inhibitor (TKI) treatment hasn’t worked or couldn’t be tolerated.
Adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Not for newly diagnosed CP-CML. In a first-line study, ponatinib 45 mg caused twice as many serious side effects as imatinib, so it should not be used for newly diagnosed chronic-phase CML.
Some leukemia cells carry a change called T315I that stops many older TKIs from working. In lab studies, ponatinib blocked both the normal ABL protein and the T315I version at very low concentrations.
A lower IC50 means a stronger effect. Bar lengths are only for illustration.
Read more about the pharmacologyAdditional kinases inhibited in vitro (IC50 0.1–20 nM)
The optimal dose of ponatinib has not been identified. In clinical trials the starting dose was 45 mg once daily; in the phase 2 trial, 68% of patients required dose reductions to 30 mg or 15 mg once daily during therapy.
This is a summary of the package insert. You’ll find the full tables in the prescribing information.
These figures come from the phase 2 trial (449 patients, 48 months of follow-up). Some of these side effects have been serious or fatal.
Heart attack, stroke and blocked arteries. This can happen within 2 weeks and at doses as low as 15 mg a day.
Blood pressure often rises during treatment and sometimes needs urgent care.
Low blood counts, severe in about half of patients, usually within the first month.
Liver damage, including liver failure. Liver tests are needed at least monthly.
Bleeding, serious in 6% of patients, mostly when platelets are very low.
Irregular heartbeat, most often atrial fibrillation.
Inflamed pancreas. Lipase is checked every 2 weeks at first, then monthly.
Serious or fatal heart failure in 6% of patients.
Other reported problems include blood clots in veins, fluid build-up, nerve damage, eye problems, tumor lysis syndrome, RPLS, slow wound healing and harm to an unborn baby. See the full warnings.
These are the checks recommended in the package insert. Your haematologist will set the exact schedule for you.
| Check | Start | M1 | M2 | M3 | M4 | M5 | M6 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Complete blood count Every 2 weeks for 3 months, then monthly |
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Serum lipase Every 2 weeks for 2 months, then monthly |
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Liver function tests Baseline, then at least monthly |
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Eye examination Baseline and periodically |
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Blood pressure Monitor and manage throughout |
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With advanced disease, drink enough fluids and get high uric acid treated first.
Stop Ponatinix at least 1 week before major surgery.
Get help right away for chest pain, breathlessness, weakness, fainting or vision changes.
Each film-coated tablet contains Ponatinib Hydrochloride INN equivalent to Ponatinib 15 mg.
Each commercial box contains 60 tablets in an HDPE pot.
Each film-coated tablet contains Ponatinib Hydrochloride INN equivalent to Ponatinib 45 mg.
Each commercial box contains 30 tablets in an HDPE pot.
Every Beacon pack has its own QR code. Please scan it before you use the medicine, because fake cancer medicines can be dangerous.
Send us an order request and we’ll get back to you to confirm availability, price and delivery before anything is shipped.