Selinexor

COMPOSITION:

Each film-coated tablet contains: Selinexor ……………………… 20mg

INDICATION:

LuciSelin is a nuclear export inhibitor indicated:

· In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

· In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

· For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

DOSAGE AND USE:

1 Multiple Myeloma in Combination with Bortezomib and Dexamethasone (Svd):

The recommended dosage of LuciSelin is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with:

· Bortezomib 1.3 mg/m administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off.

· Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week.

1.2 Multiple Myeloma in Combination with Dexamethasone (Sd):

The recommended dosage of LuciSelin is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20mg taken orally with each dose of LuciSelin on Days 1 and 3 of each week.

2 DLBCL: Recommended dosage of LuciSelin is 60 mg taken orally on Days 1 and 3 of each week.

Tablet should be swallowed whole & not chewed or crushed.

STORAGE:

Store at or below 30°C, in a dry place.

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 LuciSelin in Pregnancy and Lactation patient treatment.