Zejula (niraparib)

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Zejula (niraparib)

Zejula (niraparib) is a medication used for the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

How to buy Zejula (niraparib): You can order Zejula (niraparib) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

For this product the estimated delivery time is usually between 10 and 20 working days.

Oncology Gynaecological Cancer
Marketing Authorisation Holder Tesaro UK Limited
Mode of Action PARP inhibitor
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Strength 100 milligram

What is Zejula (niraparib) for?

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 chemotherapy1,3.

How does Zejula (niraparib) work?

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 genes1.

Where has Zejula (niraparib) been approved?

Zejula (niraparib) was approved for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer by:

  • Food and Drug Administration (FDA), USA, March 27, 20172

  • European Medical Agency (EMA), European Union, November 16, 20173

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Zejula (niraparib) taken?

The standard dosage is:

  • 300 mg (3 capsules) once daily

For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation.

Complete information about Zejula (niraparib) dosage and administration can be found in the official prescribing information listed in our resources section1,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Zejula (niraparib)?

Common side effects

The most common side effects (≥10%) listed in the prescribing information include are1,3:

  • abnormal blood counts: thrombocytopenia, anemia, neutropenia, leukopenia

  • palpitations

  • gastrointestinal disorders: nausea, constipation, vomiting, abdominal pain, diarrhoea, indigestion, dry mouth

  • myalgia, back pain, and arthralgia

  • fatigue/asthenia

  • decreased appetite, distortion of the sense of taste

  • urinary tract infection

  • AST/ALT elevation

  • headache, dizziness,

  • insomnia

  • anxiety

  • nasopharyngitis

  • dyspnea (laboured breathing)

  • cough

  • rash

  • hypertension.

Serious side effects

The serious adverse reactions listed in the prescribing information include1,3:

  • thrombocytopenia

  • anaemia

  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML).

Use in a specific population

Zejula (niraparib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3.

More Information
Working ingredient niraparib
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Oncology
Oncology Gynaecological Cancer
Indication Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Administration Oral
Mode of Action PARP inhibitor
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Tesaro UK Limited

Clinical trials – Zejula (niraparib)

The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Zejula (niraparib) 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 were based on one main double-blind, placebo-controlled study (ENGOT-OV16 / NOVA). This study involved a total of 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 cohort1,3.

Results

The major efficacy outcome measure was the progression-free survival.

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 (PFS 4 times longer) and the non-gBRCAmut cohort (PFS 2.4 times longer)1,3.

The PFS in the gBRCAmut cohort was1,3:

  • 21.0 months [95 % CI: 12.9, not reached]

  • 5.5 months [95 % CI: 3.8, 7.2] with placebo.

The PFS in the non-gBRCAmut cohort was1,3:

  • 9.3 months [95 % CI: 7.2, 11.2] with Zejula (niraparib)

  • 3.9 months [95 % CI: 3.7, 5.5] with placebo.

Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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For prescription medicines you will always need a prescription from your treating doctor. This is to ensure that your treatment is monitored and led by a doctor who is responsible for administering the medicine to you. The prescription is the evidence that your doctor gives you their medical support.
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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.