Rucaparib (Specialist drug)

Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patients should start maintenance treatment no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Duration: first-line maintenance treatment of advanced ovarian cancer — continue until disease progression, unacceptable toxicity or completion of 2 years treatment; maintenance treatment of platinum-sensitive relapsed ovarian cancer — continue until disease progression or unacceptable toxicity. If a patient vomits after taking a dose, do not retake it — take the next scheduled dose. If a dose is missed, resume with the next scheduled dose. Dose reduction levels: starting dose 600 mg twice daily (two 300 mg tablets twice daily); first reduction 500 mg twice daily (two 250 mg tablets); second reduction 400 mg twice daily (two 200 mg tablets); third reduction 300 mg twice daily (one 300 mg tablet). Manage moderate to severe (CTCAE Grade 3 or 4) reactions such as neutropenia, anaemia and thrombocytopenia by dose interruption and/or reduction. Grade 3 AST/ALT elevation without other signs of liver dysfunction: monitor LFTs weekly until resolution to Grade <=2 and continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 x ULN; interrupt if AST/ALT do not decline within 2 weeks until Grade <=2, then resume at the same or a reduced dose. Grade 4 AST/ALT elevation: interrupt until values return to Grade <=2, then resume with a dose reduction and monitor LFTs weekly for 3 weeks. Complete blood count testing before starting treatment and monthly thereafter is advised. Elderly: no starting dose adjustment for patients >= 65 years; limited clinical data in patients aged 75 or over. Hepatic impairment: no starting dose adjustment in mild or moderate impairment (monitor moderate impairment carefully); not recommended in severe hepatic impairment (total bilirubin > 3 x ULN) — no clinical data. Paediatric: safety and efficacy in children or adolescents aged less than 18 years have not been established; no data are available. Note: eMC section 4.5 (interactions) was not present in the fetched bundle, so no interaction list is given here — clinician to source.