Selpercatinib

COMPOSITION:

Each capsule contains: Selpercatinib…..………… 40mg

INDICATION:

LuciSel is a kinase inhibitor indicated for the treatment of:

· Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

· Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.

· Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

DOSAGE AND USE:

Select patients for treatment with LuciSel based on the presence of a RET gene fusion (NSCLC or thyroid) or specific RET gene mutation (MTC).

Recommended dosage in adults and pediatric patients 12 years of age or older is based on weight:

·Less than 50 kg: 120 mg orally twice daily

·50 kg or greater: 160 mg orally twice daily

Reduce LuciSel dose in patients with severe hepatic impairment.

Capsule should be swallowed whole & not chewed or crushed.

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 the reach of Children. Do not administered LuciSel in Pregnancy and Lactation patient treatment.