ICLUSIG®

Intended for licensed healthcare professionals located in Austria.

Summary of Product Characteristics – Austria

For adult patients with CML failing on one 2G TKI, ICLUSIG^® (ponatinib) combines experience and data to improve their futures^1–3*

CML

ICLUSIG is indicated 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 T315l mutation¹

Also available
for your
patients with
Ph+ ALL

Ph+ ALL

ICLUSIG is indicated in adult patients with Philadelphia
chromosome positive acute lymphoblastic leukaemia
(Ph+ ALL) who are resistant to dasatinib; who are
intolerant to dasatinib and for whom subsequent
treatment with imatinib is not clinically appropriate;
or who have the T315l mutation¹

*In PACE: 82% and 59% of CP-CML responders are estimated to maintain MCyR and MMR at 5 years, respectively (Kaplan-Meier estimates).² For patients with CP-CML, the probability
of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively.¹ In OPTIC: 48% of patients who received the 45-mg starting dose achieved MCyR
at 12 months;¹ the response-based dosing regimen resulted in a clinically manageable safety profile.³

Abbreviations: 2G, second generation; CML, chronic myeloid leukaemia; CP, chronic-phase; MCyR, major cytogenetic response; MMR, major molecular response; OPTIC, Optimizing Ponatinib Treatment In CP-CML; PACE, Ponatinib Ph+ ALL and CML Evaluation Phase 2; Ph+ ALL, Philadelphia chromosome-positive acute lymphoblastic leukaemia; TKI, tyrosine kinase inhibitor.

References: 1. ICLUSIG^® (ponatinib). Summary of Product Characteristics. Incyte. March 2022; 2. Cortes JE, et al. Blood. 2018;132:393–404; 3. Cortes J, et al. Blood. 2021;138:2042–50.

Please refer to the product information of your home country for more information.

AT/ICLG/P/24/0004
Date of preparation: September 2024

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