Niraparib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of niraparib.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
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.
Adults
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.
Contraindications
Acute myeloid leukaemia
Breastfeeding
Galactosaemia
Myelodysplastic syndrome
Pregnancy
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
Hypertension
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
Pregnancy
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.
Lactation
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
Anaemia
Anxiety
Arthralgia
Asthenia
Back pain
Bone marrow depression
Bronchitis
Cognitive impairment
Confusion
Conjunctivitis
Constipation
Cough
Decreased appetite
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Fatigue
Febrile neutropenia
Gamma glutamyl transferase (GGT) increased
Headache
Hypersensitivity reactions
Hypertension
Hypertensive crisis
Hypokalaemia
Increase in alkaline phosphatase
Increase in serum ALT/AST
Insomnia
Leukopenia
Mucositis
Myalgia
Myelodysplastic syndrome
Nasopharyngitis
Nausea
Neutropenia
Palpitations
Pancytopenia
Peripheral oedema
Photosensitivity
Pneumonitis
Posterior reversible encephalopathy syndrome (PRES)
Rash
Serum creatinine increased
Stomatitis
Tachycardia
Thrombocytopenia
Urinary tract infections
Vomiting
Weight loss
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2019
Reference Sources
Summary of Product Characteristics: Zejula 100 mg hard capsules. GlaxoSmithKline UK. Revised July 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.