Niraparib

Each film-coated tablet contains Niraparib tosylate monohydrate159.3mg equivalent to Niraparib…………………….100mg.

INDICATION:

LuciNira is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

• For the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinumbased chemotherapy.
• For the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companiondiagnostic for LuciNira.

DOSAGE AND USE:

• First-line maintenance treatment of advanced ovarian cancer: For patients weighing <77 kg (<170 lbs) OR with a platelet count <150,000/mcL, the recommended dosage is 200 mg taken orally once daily. For patients weighing ≥77 kg (170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.

Maintenance treatment of recurrent germline BRCA-mutated ovarian cancer:

• The recommended dosage is 300 mg taken orally once daily.
• If you miss a dose of LuciNira, take your next dose at your scheduled time.

Do not take an extra dose to make up for a missed dose.

STORAGE:

In a dry place and store at 20°C to 25°C.

WARNINGS:

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