Specialty medicines • Bangladesh

LuciPona 15 MG & 45 MG (Ponatinib)

LuciPona — Ponatinib. Manufactured by Lucius Pharmaceuticals (Lao) Co., Ltd.

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Description

Ponatinib

Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib. … 15mg.

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.

Ponatinib

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.

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