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Product overview

The Ponatinix

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.

Generic
Ponatinib HCl INN
Class
Kinase inhibitor
Form
Film-coated tablet
Strengths
15 mg · 45 mg
Ponatinix 45 mg pack
45mgStarting dose
Composition
Each film-coated tablet contains Ponatinib Hydrochloride INN equivalent to Ponatinib 45 mg.
Pack
Each commercial box contains 30 tablets in an HDPE pot.
Price
On request
Order Ponatinix 45
Therapeutic indication

Who it’s for.

CML

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.

Ph+ ALL

Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.

Ponatinix is not indicated or recommended for newly diagnosed chronic-phase CML.

Dosage & administration

How to take it.

  1. 01Start dosing with 45 mg orally once daily.
  2. 02Consider reducing the dose for patients with chronic phase (CP) and accelerated phase (AP) CML who have achieved a major cytogenetic response.
  3. 03Consider discontinuing if a response has not occurred by 3 months (90 days).
  4. 04May be taken with or without food. Tablets should be swallowed whole.
Special situations

When the dose changes.

Strong CYP3A inhibitors

Reduce to 30 mg once daily when given with strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, grapefruit juice).

Hepatic impairment

Recommended starting dose is 30 mg once daily (Child-Pugh A, B or C).

Adverse reactions

Interrupt, reduce (45 → 30 → 15 mg) or discontinue for myelosuppression, liver, pancreatic and other serious reactions.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of the reach of children.

Package insert (PDF) Prescribing information
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Ponatinix.

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