Dabrafenib

COMPOSITION:

Each LuciDabra Capsule contains: 88.88mg Dabrafenib mesylate equivalent to Dabrafenib……………….. 75mg

INDICATION:

LuciDabra is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation.

LuciDabra is indicated, in combination with trametinib, for:

· The treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

· The adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations and involvement of lymph node(s), following complete resection.

· The treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation.

· The treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Limitations of Use: LuciDabra is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC.

DOSAGE AND USE:

The recommended dosage of LuciDabra is 150 mg orally twice daily. Take LuciDabra at least 1 hour before or at least 2 hours after a meal.

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 LuciDabra in Pregnancy and Lactation patient treatment.