Specialty medicines • Bangladesh

LuciLena 10 MG & 25 MG (Lenalidomide)

LuciLena — Lenalidomide. Manufactured by Lucius Pharmaceuticals (Lao) Co., Ltd.

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Description

Lenalidomide

Each capsule contains: Lenalidomide……………………10mg.

INDICATIONS

LuciLena is a thalidomide analogue indicated for the treatment of adult patients with • Multiple myeloma (MM), in combination with dexamethasone. • MM, as maintenance following autologous hematopoietic stem cell transplantation (autoHSCT). • Transfusion-dependent anemia due to low – or intermediate -1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. • Previously treated follicular lymphoma (FL), in combination with a rituximab product. • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

LIMITATIONS OF USE

• LuciLena is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

DOSAGE AND USE

• MM combination therapy: 25 mg once daily orally on Days 1 -21 of repeated 28 -day cycles. * MM maintenance therapy following auto -HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles. * MDS: 10 mg once daily. • MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. • FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles. If you miss a dose of LuciLena and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

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 LuciLena during Pregnancy and Lactation.

Lenalidomide

Each capsule contains Lenalidomide………………………….25mg.

INDICATIONS

LuciLena is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone. • MM, as maintenance following autologous hematopoietic stem cell transplantation (autoHSCT). • Transfusion-dependent anemia due to low – or intermediate -1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. • Previously follicular lymphoma (FL), in combination with a rituximab product. • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

LIMITATIONS OF USE

LuciLena is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

DOSAGE AND USE

• MM combination therapy: 25 mg once daily orally on Days 1 -21 of repeated 28 -day cycles. * MM maintenance therapy following auto -HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles. * MDS: 10 mg once daily. • MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. • FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles. If you miss a dose of LuciLena and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

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

WARNINGS

Keep medicine out of reach of Children. Do not administer LuciLena during Pregnancy and Lactation.

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