Olaparib

Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. The 100 mg tablet is available for dose reduction. PROSTATE (urology) context from the same section 4.2: for monotherapy in BRCA1/2-mutated metastatic castration-resistant prostate cancer, patients must have confirmation of a deleterious or suspected deleterious BRCA1/2 mutation (tumour or blood sample) before treatment is initiated, treatment continues until progression of the underlying disease or unacceptable toxicity, and medical castration with an LHRH analogue should be continued during treatment in patients not surgically castrated. For treatment of mCRPC in combination with abiraterone and prednisone or prednisolone, no genomic testing is required before starting; the dose of abiraterone is 1000 mg orally once daily given with prednisone or prednisolone 5 mg orally twice daily, treatment continues until progression or unacceptable toxicity, and a GnRH analogue should be continued in all patients unless they have had prior bilateral orchiectomy. There are no efficacy or safety data on retreatment with olaparib in prostate cancer patients. DOSE REDUCTIONS for adverse reactions: treatment may be interrupted to manage reactions such as nausea, vomiting, diarrhoea and anaemia; the recommended dose reduction is to 250 mg (one 150 mg plus one 100 mg tablet) twice daily (500 mg total daily), and if a further reduction is required, to 200 mg (two 100 mg tablets) twice daily (400 mg total daily). CYP3A INHIBITORS: concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternatives should be considered; if a strong CYP3A inhibitor must be co-administered, reduce to 100 mg twice daily (200 mg total daily), and if a moderate CYP3A inhibitor must be co-administered, reduce to 150 mg twice daily (300 mg total daily). Missed dose: take the next normal dose at its scheduled time. Elderly: no adjustment in starting dose required. Hepatic impairment: no dose adjustment in mild or moderate impairment (Child-Pugh A or B); not recommended in severe impairment (Child-Pugh C). Baseline and monthly full blood counts are recommended for the first 12 months and periodically thereafter, because of haematological toxicity and reports of MDS/AML, and patients should be monitored for venous thromboembolism (a higher incidence was seen in mCRPC patients also receiving androgen deprivation therapy). PAEDIATRIC: safety and efficacy in children and adolescents under 18 years have not been established and no recommendation on posology can be made — no per-kg dose exists, hence paedDose is null. The SPC also covers ovarian, breast, pancreatic and endometrial indications, with combination partner doses of bevacizumab 15 mg/kg every 3 weeks and durvalumab 1500 mg every 4 weeks; those regimens are outside this urology page's scope and are recorded here only so nothing from section 4.2 is silently dropped. No section 4.5 text was captured in this bundle, so the interaction entries below come from section 4.2 and section 4.6; sections 4.4 and 4.8 were cut off at the source-fetch limit.