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 a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients with CRPC or mHSPC who are not surgically castrated.
Patients with high-risk BCR nmHSPC may be treated with Xtandi with or without a LHRH analogue. For patients who receive Xtandi with or without a LHRH analogue, treatment can be suspended if PSA is undetectable (<0.2 ng/mL) after 36 weeks of therapy. Treatment should be reinitiated when PSA has increased to ≥2.0 ng/mL for patients who had prior radical prostatectomy or ≥5.0 ng/mL for patients who had prior primary radiation therapy. If PSA is detectable (≥0.2 ng/mL) after 36 weeks of therapy, treatment should continue (see Pharmacology: Pharmacodynamics under Actions).
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 CRPC, mHSPC, or high-risk BCR nmHSPC.
Method of administration: Xtandi is for oral use. The capsules should be swallowed whole with a sufficient amount of 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.