尼拉帕尼Zejula（niraparib）

[Function and indications] Niraparib Zejula (niraparib) is used for maintenance treatment of recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in female patients who have previously received platinum chemotherapy and have achieved complete or partial response.

[Model and specifications] Capsules: 100mg

[Usage and dosage] The recommended dose is 300 mg once a day with or without food. Continue treatment until disease progression or unacceptable adverse reactions. For adverse reactions, consider interrupting treatment, reducing the dose, or stopping the administration.

[Clinical studies] Niraparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzyme activity and increased formation of PARP-DNA complexes leading to DNA damage, apoptosis, and cell death. Increased niraparib-induced cytotoxicity was observed in tumor cell lines with or without defects in BRCA1/2. Niraparib reduced tumor growth in xenograft models of BRCA1/2-deficient mouse tumor cells and in human homologous recombination-derived xenograft models with either mutant or wild-type BRCA1/2 deficiency.

[Adverse Reactions] The most common adverse reactions (incidence ≥10%) were thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/bloating, mucositis/gastritis, diarrhea, dyspepsia, dry mouth, fatigue/asthenia, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypotension.

[Pregnant women] Breastfeeding: Women are advised not to breastfeed during treatment and for 1 month after receiving the last dose.

Niraparib Zejula (niraparib) was developed by Tesaro Pharmaceuticals and was approved for marketing by the US FDA in March 2017.