Neratinib

COMPOSITION:

Each film-coated tablet contains Neratinib maleate 48.31 mg equivalent Neratinib…………40mg.

INDICATIONS

LuciNera is a kinase inhibitor indicated:

• As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.

• In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

DOSAGE AND USE:

• Extended adjuvant treatment of early-stage breast cancer: 240 mg (6 tablets) given orally once daily, with food, continuously until disease recurrence for up to one year.

• Advanced or metastatic breast cancer: 240 mg (6 tablets) given orally once daily with food on Days 1-21 of a 21-day cycle plus capecitabine (750 mg/m2 given orally twice daily) on Days 1-14 of a 21-day cycle until disease progression or unacceptable toxicities.

• Dose escalation: A two-week dose escalation for LuciNera may also be initiated.

• Dose interruptions and/or dose reductions are recommended based on individual safety and tolerability.

• Hepatic impairment: Reduce starting dose to 80 mg in patients with severe hepatic impairment.

STORAGE:

In a dry place and store at 20℃ to 25℃.

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 LuciNera during Pregnancy and Lactation.