Gynecologic cancers:

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.

Adult Dosage:

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.

Children Dosage:

Not established.

ZEJULA Warnings/Precautions:

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).

ZEJULA Classification:

Poly (ADP-ribose) polymerase (PARP) inhibitor.

ZEJULA Interactions:

Concomitant antihypertensives; dose adjustments of niraparib may be needed.

Adverse Reactions:

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:

NO

How Supplied:

Caps—30, 90

Pricing for ZEJULA

100mg capsule (Qty: 60)
Appx. price $11285
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