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. 92

• 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