Ibrutinib

COMPOSITION:

Each film-coated tablet contains Ibrutinib ……………………………….140mg.

INDICATION:

LuciBru is a kinase inhibitor indicated for the treatment of:

• Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy . This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) .

• Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.

• Adult patients with Waldenström’s macroglobulinemia (WM) .

• Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy .

This indication is approved under accelerated approval based on overall response rate.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy .

DOSAGE AND USE:

1.MCL and MZL: 560 mg taken orally once daily.

2.CLL/SLL and WM: 420 mg taken orally once daily.

3.cGVHD:Patients 12 years and older: 420 mg taken orally once daily.

Patients 1 to less than 12 years of age: 240 mg/m2 taken orally once daily (up to a dose of 420 mg).

Tablets should be taken orally with a glass of water. Do not cut, crush, or chew the tablets.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

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 LuciBru during Pregnancy and Lactation.