Description
Ibrutinib
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 Waldenstroms 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
• MCL and MZL: 560 mg taken orally once daily. • CLL/SLL and WM: 420 mg taken orally once daily. • 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.
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