This product is indicated for:
Adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis;
Treatment of adult patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or minimally symptomatic after failure of androgen deprivation therapy (ADT) and have not received chemotherapy.
Dosage
The recommended dose is 160 mg of enzalutamide (four 40 mg softgels) orally once daily.
Men undergoing non-surgical castration should continue medical castration with a luteinizing hormone-releasing hormone (LHRH) analog during treatment.
If a patient misses a scheduled dose, the prescribed dose should be taken as soon as possible. If a dose is missed by a full day, the usual daily dose should be resumed the following day.
If a patient experiences Grade 3 or higher toxicity or intolerable adverse reactions, the drug should be discontinued for one week or until symptoms resolve to Grade 2 or lower, after which the drug should be resumed at the same dose or, if necessary, at a reduced dose (120 or 80 mg). Concomitant use with strong CYP2C8 inhibitors
Concomitant use with strong CYP2C8 inhibitors should be avoided whenever possible. If a strong CYP2C8 inhibitor must be used concomitantly, the enzalutamide dose should be reduced to 80 mg once daily. After discontinuation of the strong CYP2C8 inhibitor, the enzalutamide dose should be restored to the pre-coadministration dose (see [Drug Interactions]).
Hepatic Impairment
No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C, respectively).
Renal Impairment
No dose adjustment is required for patients with mild or moderate renal impairment (see [Pharmacokinetics]). This product should be used with caution in patients with severe renal impairment or end-stage renal disease (see [Precautions]).
Children and Adolescents
Enzalutamide is indicated for the treatment of castration-resistant prostate cancer in adult men. There is no experience with its use in children or adolescents. Elderly
No dosage adjustment is required for elderly patients (see [Geriatric Use] and [Pharmacokinetics]).
Administration
This product is for oral use. Do not chew, dissolve, or open the softgels. Take the whole capsule with water, with or without food.
