Apalutamide

Treatment should be initiated and supervised by an appropriate prescriber experienced in the treatment of prostate cancer. Medical castration with a gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated. If a dose is missed it should be taken as soon as possible the same day, returning to the normal schedule the following day; extra tablets should not be taken to make up a missed dose. For >= Grade 3 toxicity or an intolerable adverse reaction, hold dosing rather than permanently discontinuing until symptoms improve to <= Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg) if warranted. Severe hepatic impairment (Child-Pugh Class C): 120 mg (two 60 mg tablets) orally once daily; no dose adjustment for mild or moderate hepatic impairment (Child-Pugh A and B) or for elderly patients. Swallow the tablet whole with or without food; do not crush or split. For patients who cannot swallow the tablet whole, it may be dispersed in about 10 mL non-fizzy water for 2 minutes, then mixed with 30 mL of orange juice, green tea, applesauce, drinkable yogurt or additional water and swallowed immediately; it may also be given via a nasogastric tube 8 French or greater (disperse in 10 mL non-fizzy water in a >=20 mL syringe, wait 10 minutes, shake vigorously, administer immediately and flush). Paediatric: there is no relevant use of apalutamide in the paediatric population.