niraparib 100 mg
1 INDICATIONS AND USAGE ZEJULA 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 platinum-based chemotherapy. ( 1.1 ) • 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 companion diagnostic for ZEJULA. ( 1.2 , 2.1 ) 1.1 First-Line Maintenance Treatment of Advanced Ovarian Cancer ZEJULA is 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 platinum-based chemotherapy. 1.2 Maintenance Treatment of Recurrent Germline BRCA -mutated Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA mut) 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 companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] .
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CAPSULE PURPLE niraparib 100 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING ZEJULA is available as capsules having a white body printed with “100 mg” in black ink, and a purple cap printed with “
NIRAPARIB” in white ink. Each capsule contains 100 mg of
NIRAPARIB free base. ZEJULA capsules are packaged as 30-count bottles NDC 69656-103-30 Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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