COMPOSITION: Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 45mg. INDICATION: ndication: LuciPona is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL. Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. DOSAGE AND USE: • Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1. • Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily. • Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily. LuciPona may be taken with or without food. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos
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