Active Ingredient: Ponatinib
Ponatinib is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 45 milligrams ponatinib, once daily.
The recommended starting dose is 45 mg of ponatinib once daily. Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Patients should be monitored for response according to standard clinical guidelines.
Discontinuing ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days).
The risk of arterial occlusive events is likely to be dose-related. Reducing the dose of ponatinib to 15 mg should be considered for CP-CML patients who have achieved a molecular response (MR2 i.e. ≤1% BCR-ABL1IS) taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to response, and BCR-ABL transcript levels.
If dose reduction is undertaken, close monitoring of response is recommended. In patients with loss of response the dose of ponatinib can be re-escalated to a previously tolerated dose of 30 mg or 45 mg orally once daily. Ponatinib should be continued until loss of response at the re escalated dose or unacceptable toxicity.
Ponatinib dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities. In the case of severe adverse reactions, treatment should be withheld.
For patients whose adverse reactions are resolved or attenuated in severity, ponatinib may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate.
Ponatinib may be taken with or without food.
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