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:
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. Dose adjustments for adverse reactions: see full labeling.
Children:
Not established.
Warnings/Precautions:
Discontinue if myelodysplastic syndrome/acute myeloid leukemia 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. Severe renal impairment or ESRD undergoing hemodialysis. Moderate to severe hepatic impairment. 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).
Pharmacologic Class:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
Interactions:
Concomitant antihypertensives; dose adjustments of Zejula may be needed.
Adverse Reactions:
Nausea, fatigue, thrombocytopenia, anemia, vomiting, constipation, abdominal pain, musculoskeletal pain, decreased appetite, neutropenia, insomnia, headache, dyspnea, diarrhea, hypertension, cough, dizziness, hypomagnesemia, urinary tract infection, acute kidney injury, WBC count decreased.
Elimination:
Renal, fecal. Half-life: 36 hours.
Generic Availability:
NO
How Supplied:
Caps—30, 90
