Composition
Cap 100 mg: Niraparib 100 mg.
Indications & Dosage
Advanced ovarian cancer, Advanced fallopian tube cancer, Advanced peritoneal cancer: Adult (body-weight up to 77 kg): 200 mg once daily, for dose adjustments due to side-effects; consult product literature. Adult (body-weight 77 kg and above): 300 mg once daily, baseline platelet count should be 150x109/litre or above for this dose schedule, for dose adjustments due to side-effect; consult product literature Relapsed ovarian cancer, Relapsed fallopian tube cancer, Relapsed peritoneal cancer: 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.
Precautions
Pre-existing hypertension (control before treatment initiation), use effective contraception in women of childbearing potential during treatment and for 1 month after receiving the last dose. Caution in severe hepatic and renal impairment. Monitor full blood count weekly for the 1st month of treatment, then monthly for the next 10 months and periodically thereafter, monitor blood pressure weekly for the 1st 2 months of treatment, then monthly for the 1st year, and periodically thereafter.
Interactions
CYP3A4 inhibitors
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Anaemia, angioedema, anxiety, arthralgia, asthenia, cognitive impairment, concentration impaired, conjunctivitis, constipation, depression, diarrhoea, dizziness, dry mouth, dyspnoea, epistaxis, GI discomfort, headache, hypertension, hypokalaemia, increased risk of infection, insomnia, leucopenia, memory impairment, mucositis, myalgia, nausea, neutropenia, palpitations, peripheral oedema, photosensitivity reaction, skin reactions, stomatitis, tachycardia, taste altered, thrombocytopenia, vomiting, confusion, pancytopenia, pneumonitis. Rare: Posterior reversible encephalopathy syndrome (PRES), acute myeloid leukaemia (discontinue permanently), hot flush, myelodysplastic syndrome (discontinue permanently).