LuciEntre

Description

COMPOSITION:

Each LuciEntre capsule contains: Entrectinib ……. 100mg

INDICATION:

LuciEntre is a kinase inhibitor indicated for the treatment of:

• Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

• Adult and pediatric patients 12 years of age and older with solid tumors that:

▪have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDA-approved test without a known acquired resistance mutation,

▪are metastatic or where surgical resection is likely to result in severe morbidity, and

▪have progressed following treatment or have no satisfactory alternative therapy.

DOSAGE AND USE:

• Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily.

• Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors:

▪Adults: 600mg orally once daily.

▪Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below

□ BSA greater than 1.50 m2: 600 mg once daily.

□ BSA 1.11 to 1.50 m2: 500 mg once daily.

□ BSA 0.91 to 1.10 m2: 400 mg once daily.

Capsules 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 reach of Children. Do not administer LuciEntre during Pregnancy and Lactation.