niraparib tosylate monohydrate: clinical use

Prescribing considerations

• Initiate and supervise treatment through a clinician experienced in anticancer therapy.
• Confirm recovery from previous chemotherapy-related haematological toxicity and review baseline blood counts, body weight, platelet count and blood pressure.
• Control pre-existing hypertension before treatment.
• Review hepatic and renal function; evidence is limited in severe impairment.
• Investigate prolonged cytopenias and refer for haematology assessment if MDS or AML is suspected.

Contraindications and cautions

• Hypersensitivity to niraparib or any product excipient
• Breastfeeding

Monitoring

• Full blood count intensively during early treatment, then regularly throughout therapy.
• Blood pressure frequently during early treatment, regularly during the first year and periodically thereafter.
• Assess promptly for bleeding, infection, anaemia, persistent cytopenias, hypertension, PRES and pneumonitis.
• Monitor glucose control when starting or stopping niraparib in a patient taking metformin.

Clinical pharmacology

Niraparib inhibits PARP-1 and PARP-2, increasing PARP–DNA complexes, DNA damage and tumour-cell death. It has a long terminal half-life, is metabolised mainly by carboxylesterases and is eliminated through renal and hepatobiliary routes.

Formulation and product differences

• The selected product is a grey, oval film-coated tablet containing lactose.
• Tablet and legacy capsule formulations have demonstrated bioequivalence, but products should be used exactly as prescribed.
• Store tablets in their original packaging to protect them from high humidity.

Tablet

Route: Oral

Strengths: 100 mg