ICLUSIG (ponatinib) response-based dosing: The path to maximize efficacy and mitigate risk

45 mg —> 15 mg for patients who achieve ≤1%BCR::ABL1IS 

ICLUSIG OPTIC trial established a response-based dosing strategy in CP-CML1

RX icon. Start at 45 mg. Initiate treatment at 45 mg orally once daily. Start at 30 mg orally once daily in patients taking strong CYP3A inhibitors and in patients with preexisting hepatic impairment (Child-Pugh A,B, or C).
Down arrow icon. Reduce to 15 mg. Reduce the dose to 15 mg orally once daily after less than or equal to 1 percent BCR-ABL1 is achieved. In the OPTIC Trial, of the 93 patients who received ICLUSIG 45 mg to15 mg, 52 achieved ≤ BCR::ABL1 at any time. Consider discontinuing ICLUSIG if hematologic response has not occurred by 3 months.
Check mark icon. Maintain at 15 mg. Patients can continues with the 15mg, once-daily dose of ICLUSIG for as long as they maintain response. Patients who lose response can have their dose re escalated to a previously tolerated dosage of 30 mg or 45 mg orally once daily. Of the 52 patients who achieved   ≤1% BCR::ABL at any time 113 patients lost response and had their dose re escalated. 62% of these patients (n=8/13) regained response following dose reescalation. Patients taking 15 mg orally once daily who e

aThe primary endpoint for OPTIC was ≤1% BCR::ABL1 at 12 months.1

Find the full dosing guide for ICLUSIG

Learn about depth of response with ICLUSIG

BCR::ABL1IS=BCR::ABL1 international scale; CP-CML=chronic-phase chronic myeloid leukemia