XTANDI™ SOFT CAPSULES 40MG

CAPSULE, LIQUID FILLED

**4.2 Posology and method of administration** Posology The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a single oral daily dose. Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. Xtandi can be taken with or without food and should be taken at approximately the same time every day. If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose. If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted. _Concomitant use with strong CYP2C8 inhibitors_ The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily. If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly_ No dose adjustment is necessary for older people (see section 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ No dose adjustment is necessary for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C, respectively). An increased drug half-life has however been observed in patients with severe hepatic impairment (see section 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with castration-resistant prostate cancer or metastatic hormone-sensitive prostate cancer. Method of administration Xtandi is for oral use. The capsules should be swallowed whole with water. Do not chew, dissolve or open.