Indications for: ZEJULA
Maintenance treatment in adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Maintenance treatment in adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Treatment in adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed >6 months after response to the last platinum-based chemotherapy.
Swallow whole. First-line maintenance of advanced ovarian cancer: start within 12 weeks after most recent platinum-containing regimen; (patients <77kg or with platelets <150000/μL): 200mg once daily; (patients ≥77kg and platelets ≥150000/μL): 300mg once daily. Maintenance of recurrent ovarian cancer (start within 8 weeks after most recent platinum-containing regimen) or advanced ovarian cancer after ≥3 prior chemotherapies (select patients using FDA-approved tests): 300mg once daily. Continue until disease progression or unacceptable toxicity. Moderate hepatic impairment: 200mg once daily; monitor, reduce dose further if needed. Dose adjustments for adverse reactions: see full labeling.
Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Monitor CBCs weekly for the first month, monthly for the next 11 months then periodically thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1); discontinue if toxicities unresolved within 28 days after interruption (see full labeling). Monitor BP and heart rate at least weekly for the first 2 months, then monthly for the first year then periodically thereafter. Cardiovascular disorders (eg, coronary insufficiency, arrhythmias, hypertension); monitor closely. Discontinue promptly if posterior reversible encephalopathy syndrome (PRES) is suspected. Asthma. Aspirin sensitivity. Severe renal impairment or ESRD undergoing hemodialysis. Severe hepatic impairment (total bilirubin >3×ULN and any AST level). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during therapy and for ≥6 months after the last dose. Pregnancy: exclude status prior to initiating therapy. Nursing mothers: not recommended (during and for 1 month after the last dose).
Poly (ADP-ribose) polymerase (PARP) inhibitor.
Concomitant antihypertensives; dose adjustments of niraparib may be needed.
Nausea, thrombocytopenia, anemia, fatigue, constipation, musculoskeletal pain, abdominal pain, vomiting, neutropenia, decreased appetite, leukopenia, insomnia, headache, dyspnea, rash, diarrhea, hypertension, cough, dizziness, acute kidney injury, urinary tract infection, hypomagnesemia; MDS/AML, PRES.
Generic Drug Availability: