Zejula (niraparib
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 chemotherapy[1,3].
It is available in capsule form each containing 100mg niraparib.
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 genes.[1]
Where has Zejula (niraparib) been approved?
Zejula (niraparib) was approved for the indications: recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer by:
Food and Drug Administration (FDA), USA, March 27, 2017[2]
European Medical Agency (EMA), European Union, November 16, 2017[3]
Health Canada, June 26, 2019[5]
Therapeutic Goods Administration (TGA), Australia, July 1, 2019[4]
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 for assistance.
Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.
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.
everyone.org is an intermediate and our services are not intended as medical advice. Complete information about Zejula (niraparib) dosage and administration can be found in the official prescribing information listed in our references section[1,3].
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 are[1,3]:
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.
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Zejula (niraparib)
This medicine requires a prescription. See “Prescription Guide”.
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Zejula (niraparib) is a medication used for the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
For this product the estimated delivery time is usually between 10 and 20 working days.
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Zejula
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Disease Indications
Gynaecological Cancer
Manufacturer
Tesaro UK Limited
Usage
Oral
Medicine approved by
European Medical Agency (EMA)
Food and Drug Administration (FDA)
Health Canada
Therapeutic Goods Administration (TGA)
Patients helped
Over 1.2 million patients reached
More than 11,000 patients helped
100% successful deliveries to 88 countries
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Zejula (niraparib)
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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 chemotherapy[1,3].
It is available in capsule form each containing 100mg niraparib.
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 genes.[1]
Where has Zejula (niraparib) been approved?
Zejula (niraparib) was approved for the indications: recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer by:
Food and Drug Administration (FDA), USA, March 27, 2017[2]
European Medical Agency (EMA), European Union, November 16, 2017[3]
Health Canada, June 26, 2019[5]
Therapeutic Goods Administration (TGA), Australia, July 1, 2019[4]
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 for assistance.
Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.
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.
everyone.org is an intermediate and our services are not intended as medical advice. Complete information about Zejula (niraparib) dosage and administration can be found in the official prescribing information listed in our references section[1,3].
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 are[1,3]:
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 include[1,3]:
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 information[1,3].
References
1. Summary of Product Characteristics [FDA]: Zejula (niraparib) [PDF]
Manufacturer, Mar. 2017
2. Approved Drugs: Niraparib (Zejula)
FDA, March 2017
3. Summary of Product Characteristics [EMA]: Zejula (niraparib) [PDF]
Tesaro, Nov. 2017
4. Summary of Product Characteristics [TGA]: Zejula (niraparib) [PDF]
Tesaro, Jul. 2019.
5. Summary of Product Characteristics [Health Canada]: Zejula (niraparib) [PDF]
Tesaro, Jul. 2019.