Specialty medicines • Bangladesh

LuciAvap 100 MG (Avapritinib)

LuciAvap — Avapritinib. Manufactured by Lucius Pharmaceuticals (Lao) Co., Ltd.

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Description

Avapritinib

Each film-coated tablet contains Avapritinib … 100mg.

INDICATION

LuciAvap is a kinase inhibitor indicated for: 1) Gastrointestinal Stromal Tumor (GIST) : • The treatment of adults with unresectable or metastatic GIST harboring a platelet – derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. 2) Advanced Systemic Mastocytosis (AdvSM) : • The treatment of adult patients with AdvSM. AdvSM includes patients with aggressive systemic Mastocytosis (ASM), systemic Mastocytosis with an associated hematological neoplasm (SM- AHN), and mast cell leukemia (MCL). • Limitations of Use: LuciAvap is not recommended for the treatment of patients with AdvSM with platelet counts of less than 50 X 109/L. 3) Indolent Systemic Mastocytosis (ISM) : • The treatment of adult patients with ISM. • Limitations of Use: LuciAvap is not recommended for the treatment of patients with ISM with platelet counts of less than 50 X 109/L.

DOSAGE AND USE

• GIST: Select patients for treatment with LuciAvap based on the presence of a PDGFRA exon 18 mutation. • GIST: The recommended dosage is 300 mg orally once daily.

• AdvSM: The recommended dosage is 200 mg orally once daily. • ISM: The recommended dosage is 25 mg orally once daily. • Patients with severe hepatic impairment (Child -Pugh Class C): reduce dose of LuciAvap.

STORAGE

In a dry place and store at 20℃ to 25℃.

WARNING

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

PLEASE SEE PACKAGE INSERT

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