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Information about Niraparib

  Niraparib is a small molecule inhibitor of poly ADP-ribose polymerase that is used in the therapy of selected patients with refractory and advanced ovarian carcinoma. 

Liver safety of Niraparib

Niraparib therapy is associated with a low rate of transient elevations in serum aminotransferase during therapy, but has not been linked to instances of clinically apparent liver injury

Mechanism of action of Niraparib

Niraparib (nye rap' a rib) is an orally available, small molecule inhibitor of poly adenine diphosphate (ADP)-ribose polymerase (PARP), an enzyme involved in DNA transcription and repair.  Patients with mutations of the BRCA 1 and 2 genes are at increased risk for cancer, particularly ovarian and breast cancer in women.  The BRCA gene encodes DNA repair enzymes, and tumor cells with BRCA mutations have an increased dependence on PARP and increased sensitivity to its inhibition.  Clinical trials of niraparib in women with advanced, refractory ovarian, fallopian tube or primary peritoneal carcinoma have shown response rates of 30% to 40% and prolongation of progression-free survival.  Niraparib is also under evaluation as therapy for advanced breast cancer and other malignant diseases associated mutations in BRCA or other DNA repair enzymes. 

FDA approval information for Niraparib

Niraparib received approval for use in the United States in 2017 for therapy of advanced and refractory advanced, refractory ovarian, fallopian tube or primary peritoneal carcinoma. 

Dosage and administration for Niraparib

Niraparib is available in 100 mg capsules under the brand name Zejula.  The recommended dose is 300 mg by mouth once daily continued until disease progression or unacceptable toxicity occurs. 

Side effects of Niraparib

Common side effects include anemia, fatigue, nausea, diarrhea, constipation, dyspepsia, abdominal pain, anorexia, shortness of breath and thrombocytopenia.  Uncommon, but potentially severe side effects include myelodysplastic syndrome, marked bone marrow suppression, cardiovascular events and embryo-fetal toxicity.


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