Active Ingredient: Ponatinib
Ponatinib is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 30 milligrams ponatinib, once daily.
The recommended starting dose is 30 mg of ponatinib once daily in combination with chemotherapy with a dose reduction to 15 mg once daily upon achievement of Minimal Residual Disease (MRD)-negative complete response (≤0.01% BCR-ABL1) at the end of induction.
Patients with loss of MRD negativity can re-escalate the dose of ponatinib to a previously tolerated dose of up to 30 mg once daily. After completion of ponatinib in combination with chemotherapy, continue treatment with ponatinib as monotherapy until loss of response at the re-escalated dose or unacceptable toxicity.
CNS prophylaxis or treatment, steroid induction, anti-CD20 therapy in CD20+ patients or chemotherapy as applicable should follow the respective Summaries of Product Characteristics and standard clinical guidelines.
Discontinuing ponatinib should be considered if a complete molecular response has not occurred after the induction phase.
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. When ponatinib is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied, see their respective Summary of Product Characteristics and standard clinical guidelines.
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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