Ponatinib 45mg

COMPOSITION:

Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib………………………………. 45mg.

INDICATION:

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

WARNING:

Keep medicine out of reach of Children. Do not administer LuciPona during Pregnancy and Lactation.