Xtandi Dosage/Direction for Use

Posology: The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a single oral daily dose.
Medical castration with an LHRH analogue should be continued during treatment of patients not surgically castrated.
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 Interactions).
Elderly: No dose adjustment is necessary for elderly patients (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is necessary for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B or C, respectively) (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary for patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). Caution is advised in patients with severe renal impairment or end-stage renal disease (see Precautions).
Pediatric population: There is no relevant use of enzalutamide in the pediatric population in the indication of treatment of adult men with castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.
Method of administration: Xtandi is for oral use. The capsules should be swallowed whole with water, and can be taken with or without food. Do not chew, dissolve or open. Enzalutamide should be taken at approximately the same time every day.