Niraparib (Zejula®) was approved in October 2019 for patients with homologous recombination deficiency (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer.
Poly (ADP-ribose) polymerase (PARP) inhibitor
Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens whose cancer is associated with HRD-positive status defined by either
- A deleterious or suspected deleterious BRCA mutation
- Genomic instability and progression more than six months after response to the last platinum-based chemotherapy
300 mg, once daily
Orally, with or without food
More than 10% of patients in clinical trials experienced 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, or white blood cell count decrease. Serious side effects include myelodysplastic syndrome/acute myeloid leukemia, bone marrow suppression, cardiovascular changes, and embryo-fetal toxicity.
Monitor complete blood counts weekly for the first month of therapy, then monthly for the next 11 months, and periodically thereafter for clinically significant changes. Hypertension and hypertensive crisis have been reported in patients on niraparib; monitor blood pressure and heart rate at least weekly for the first two months of therapy, then monthly for the first year, and periodically thereafter. Dose modifications may be indicated for hematologic and nonhematologic adverse reactions; see full prescribing information for dose modifications. A pregnancy test is recommended prior to starting treatment.
No clinical drug interaction studies have been performed.
Swallow the capsule whole without cutting or crushing it. Store the medication at room temperature away from light and moisture. Take the dose at bedtime to assist in reducing nausea. If you vomit or miss a dose, take the next one at the regular time. Do not take additional doses. Female patients of reproductive potential must use effective contraception during treatment and for at least six months after the last dose; breastfeeding is not advised during treatment and for one month following the last dose. Contact your healthcare provider if you experience weakness, fever, weight loss, bruising, bleeding easily, blood in urine or stool, or increased blood pressure.
No differences in safety and effectiveness were observed in patients aged 65 or older versus younger patients, although greater sensitivity for some older adults cannot be ruled out.
Niraparib is genotoxic and has the potential to cause teratogenicity in humans.
Information is available at Tesaro’s website or by calling 844-283-7276.