Drug Action
Niraparib is an inhibitor of PARP enzymes which are involved in DNA repair. PARP inhibition results in disruption of cellular homoeostasis and cell death.
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Drug reference
Niraparib is an inhibitor of PARP enzymes which are involved in DNA repair. PARP inhibition results in disruption of cellular homoeostasis and cell death.
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Ovarian cancer (initiated by a specialist) | Fallopian tube cancer (initiated by a specialist) | Peritoneal cancer (initiated by a specialist) ▶BY MOUTH ▶Adult: 300 mg once daily, consider initial dose of 200 mg in patients with body-weight less than 58 kg, for dose adjustments due to side-effects—consult product literature
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Pre-existing hypertension (control before treatment initiation)
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NICE decisions ▶Niraparib for maintenance treatment of relapsed, platinum- sensitive ovarian, fallopian tube and peritoneal cancer (July 2018) NICE TA528 Niraparib (Zejula ®) is recommended for use within the Cancer Drugs Fund as an option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults, only if: . they have a germline BRCA mutation and have had 2 courses of platinum-based chemotherapy, or . they do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy, and . the conditions in the managed access agreement for niraparib are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta528 Scottish Medicines Consortium (SMC) decisions SMC No. 1341/18 The Scottish Medicines Consortium has advised (August 2018) that niraparib (Zejula ®) is accepted for restricted use within NHS Scotland as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is restricted to those patients who do not have a germline BRCA mutation. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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▶Common or very common Anaemia. anxiety. appetite decreased. arthralgia. asthenia. back pain. conjunctivitis. constipation. cough. depression. diarrhoea. dizziness. dry mouth. dyspnoea. epistaxis. gastrointestinal discomfort. headache. hypertension. hypokalaemia. increased risk of infection. insomnia. leucopenia. mucositis. myalgia. nausea. neutropenia. palpitations. peripheral oedema. photosensitivity reaction. rash. stomatitis. tachycardia. taste altered. thrombocytopenia. vomiting. weight decreased ▶Uncommon Pancytopenia ▶Frequency not known Acute myeloid leukaemia (discontinue permanently). myelodysplastic syndrome (discontinue permanently)
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for 1 month after receiving the last dose.
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid during treatment and for 1 month after last dose—no information available.
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Manufacturer advises caution in severe impairment (no information available).
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Manufacturer advises caution in severe impairment—no information available.
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▶Manufacturer advises monitor full blood count weekly for the first month of treatment, then monthly for the next 10 months and periodically thereafter. ▶Manufacturer advises monitor blood pressure monthly for the first year of treatment and periodically thereafter.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 25 ▶Zejula (Tesaro UK Ltd) A Niraparib (as Niraparib tosylate monohydrate) 100 mg Zejula 100mg capsules | 56 capsule P £4,500.00 (Hospital only) | 84 capsule P £6,750.00 (Hospital only)
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Driving and skilled tasks Manufacturer advises patients and their carers should be counselled on the effects on driving and skilled tasks—increased risk of dizziness and fatigue.
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300 mg once daily, consider initial dose of
First-line fragment. Read the complete Indications and Dose section above.
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