Zejula (niraparib)

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Zejula (niraparib)

How to buy Zejula (niraparib): You can order Zejula (niraparib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Tesaro
Disease Ovarian, Fallopian Tubes and Peritoneal Cancer
Indication Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Mode of Action PARP inhibitor
Approval Status EMA approved (EU); FDA approved (USA)
Strength 100 mg

Who is Zejula (niraparib) for?

Zejula (niraparib) is indicated as a maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy [1][3].

Zejula (niraparib) recommended dose

Complete information about Zejula (niraparib) dosage and administration can be found here: [1][3]
The standard dosage is:
  • 300 mg (3 capsules) once daily
For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation.
Consult your treating doctor for personalised dosing.

What is Zejula (niroparib) niraparib and how does it work?

Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor, indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy [1][3].

PARP enzymes, PARP-1 and PARP-2, play a role in DNA repair. Niraparib, by inhibiting these enzymes, induces death in tumour cells. Niraparib has shown efficacy in both cells with or without deficiencies in the genes involved in the repair of damaged DNA, namely the BRCA genes [1].

What is Zejula's (niraparib) approval status?

Zejula (niraparib) was approved by:
  • FDA (USA) on March 27, 2017 [2]
  • EMA (EU) on November 16, 2017 [3]
for 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 [1][3].

The approval of Zejula (niraparib) was based on one main double-blind, placebo-controlled study (NOVA) involving 533 patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. All patients had received at least two prior platinum-containing regimens and were responding to their current platinum-based regimen (completely or partially). The patients were assigned to one of two groups depending on whether a mutation was detected in the BRCA gene. A total of 203 patients were assigned to the germline BRCA mutated (gBRCAmut) cohort, and 350 to the non-gBRCAmut cohort. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients on niraparib as compared with placebo in both the gBRCAmut cohort and the non-gBRCAmut cohort [1][3].

In the gBRCAmut cohort, the PFS for patients treated with niraparib was 4 times longer than for patients on placebo (21.0 months (95 % CI: 12.9, not reached) vs. 5.5 months (95 % CI: 3.8, 7.2). In the non-gBRCAmut cohort, the PFS for patients treated with niraparib was 2.4 times longer than for patients on placebo (9.3 months (95 % CI: 7.2, 11.2) vs. 3.9 months (95 % CI: 3.7, 5.5) [1][3].
Among the most common adverse reactions were blood deficiencies, palpitations, nausea, constipation, and vomiting. Bone marrow disorders, such as myelodysplastic syndrome or acute myeloid leukemia, occurred in 1.4 % of the patients receiving niraparib and in 1.1 % of patients assigned to placebo. Grade 3-4 hypertension occurred in 9 % of niraparib- treated patients compared with 2 % of patients assigned to placebo [1][3].
References
[1] Summary of Product Characteristics [FDA]: Zejula (niraparib), Manufacturer, Mar. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
[2] FDA. Approved Drugs: Niraparib (Zejula), 27/03/2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm548487.htm
[3] Summary of Product Characteristics [EMA]: Zejula (niraparib), Tesaro, Nov. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004249/WC500239289.pdf

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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