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Niraparib oral

Updated 2 Feb 2023 | Niraparib


Oral formulations of niraparib.

Drugs List

  • niraparib 100mg capsules
  • ZEJULA 100mg capsules
  • Therapeutic Indications


    First line treatment of ovarian, fallopian tube and peritoneal cancer
    Recurrent ovarian, fallopian tube and peritoneal cancer

    Monotherapy for the maintenance treatment of adults with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of first-line platinum-base chemotherapy.

    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 to platinum-base chemotherapy.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.

    Treatment should be continued until disease progression.


    First-line ovarian cancer maintenance treatment
    200mg once daily.

    Starting dose of 300mg should be used for patients who weigh more than or equal to 77kg and have a baseline platelet count of greater than or equal to 150,000/microlitre.

    Recurrent ovarian cancer maintenance treatment
    300mg once daily.

    Starting dose of 200mg should be considered for patients with body weight below 58kg.

    Patients with Hepatic Impairment

    Moderate hepatic impairment
    Recommended starting dose: 200mg once daily

    Additional Dosage Information

    Missed Doses
    If a dose is missed, take the next dose at the regular scheduled time.

    If adverse reactions occur
    Starting dose: 300mg
    First dose reduction: 200mg daily
    Second dose reduction: 100mg daily
    If further dose reduction is required below 100mg/day, then discontinue treatment.

    Starting dose: 200mg
    First dose reduction: 100mg daily
    Second dose reduction: Discontinue treatment.

    Dose modifications for non-haematologic adverse reactions
    Non-haematologic Common Terminology Criteria for Adverse Events Grade 3 or above: Withhold treatment for up to 28 days or until adverse reaction resolved. Resume treatment at a reduced dose level. If the adverse reaction reoccurs withhold treatment for up to 28 days or until adverse reaction resolved. Resume treatment at a reduced dose level or discontinue treatment.

    Dose modifications for haematologic adverse reactions
    Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support: For patients with platelet count less than or equal to 10,000 per microlitre, platelet transfusion should be considered. If there are risk factors for bleeding such as co-administration of anticoagulation or antiplatelet drugs, consider interrupting these substances and/or transfusion at a higher platelet count. Resume treatment at a reduced dose.
    Platelet count below 100,000 per microlitre: Withhold treatment for up to 28 days and monitor blood counts weekly until platelet count returns to 100,000 per microlitre or above. Resume treatment at the same or reduced dose based on clinical evaluation. If the adverse reaction reoccurs, withhold treatment for up to 28 days and monitor blood counts weekly until platelet counts return to 100,000 per microlitre or above. Resume treatment at a reduced dose. If dose has already been reduced to 100mg, or if the platelet count has not returned to acceptable level within 28 days, treatment should be discontinued.
    Neutrophil count below 1000 per microlitre: Withhold treatment for up to 28 days and monitor blood counts weekly until neutrophil count returns to 1500 per microlitre or above. Resume treatment at reduced dose.
    Haemoglobin below 8g/dL: Withhold treatment for up to 28 days and monitor blood counts weekly until haemoglobin returns to 9g/dL or above. Resume treatment at reduced dose.

    If neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if dose has already been reduced to 100mg, treatment should be discontinued.


    Acute myeloid leukaemia
    Myelodysplastic syndrome

    Precautions and Warnings

    Children under 18 years
    Haemoglobin concentration below 8g / dL
    Neutrophil count below 1.0 x 10 to the power of 9 / L
    Patients over 75 years
    Platelet count below 100 x 10 to the power of 9/ L
    Recent anticoagulant therapy
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Severe hepatic impairment
    Severe renal impairment

    Administration of live vaccines is not recommended
    Reduce dose in patients with moderate hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Ensure hypertension is controlled prior to treatment
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Some brands contain tartrazine
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor blood counts weekly for 1 month, then monthly thereafter
    Monitor blood pressure weekly for 2 months then monthly thereafter
    Monitor patients with hepatic impairment
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Consider platelet transfusion if count below 10x10 to the power 9/L
    Discontinue if no improvement after dosage adjustment over a 1 month period
    Discontinue if persistent hypertension unresponsive to therapy occurs
    Discontinue if platelet count not increased sufficiently after 4 weeks
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Interrupt if haemoglobin falls below 8 g/dL
    Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
    Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
    Suspend treatment if platelet count is less than 100,000 per cubic mm
    Female: Contraception required during and for 1 month after treatment
    Breastfeeding: Do not breastfeed during & for 1 month after treatment

    Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
    Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

    Pregnancy and Lactation


    Niraparib is contraindicated during pregnancy.

    Use of niraparib during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of niraparib during pregnancy. Potential risks are unknown, however based on its mechanism of action, niraparib could cause teratogenic effects.


    Niraparib is contraindicated during breastfeeding.

    Breastfeeding is contraindicated by the manufacturer during treatment and for 1 month after the last dose. The presence of niraparib in human breast milk and its effects on exposed infants are unknown.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute myeloid leukaemia
    Back pain
    Bone marrow depression
    Cognitive impairment
    Decreased appetite
    Dry mouth
    Febrile neutropenia
    Gamma glutamyl transferase (GGT) increased
    Hypersensitivity reactions
    Hypertensive crisis
    Increase in alkaline phosphatase
    Increase in serum ALT/AST
    Myelodysplastic syndrome
    Peripheral oedema
    Posterior reversible encephalopathy syndrome (PRES)
    Serum creatinine increased
    Urinary tract infections
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2019

    Reference Sources

    Summary of Product Characteristics: Zejula 100 mg hard capsules. GlaxoSmithKline UK. Revised July 2021.

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