Erleada Dosage/Direction for Use

Dosage: The recommended dose of Apalutamide (Erleada) is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. Apalutamide (Erleada) can be taken with or without food.
Dose modification: If a patient experiences a ≥ Grade 3 toxicity or an intolerable side effect, hold dosing 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.
Missed dose(s): If the patient misses a dose, it should be taken as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose.
Special populations: Pediatrics (17 years of age and younger): The safety and effectiveness of Apalutamide (Erleada) in children have not been evaluated.
There is no relevant use of Apalutamide (Erleada) in pediatric patients aged 17 years and younger.
Elderly (65 years of age and older): Of the 1327 subjects who received Apalutamide (Erleada) in clinical studies, 19% of subjects were less than 65 years, 41% of subjects were 65 years to 74 years, and 40% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Renal impairment: A dedicated renal impairment study for Apalutamide (Erleada) has not been conducted. Based on the population pharmacokinetic analysis using data from clinical studies in subjects with castration-resistant prostate cancer (CRPC) and healthy subjects, no significant difference in systemic exposure was observed in subjects with pre-existing mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] between 30 to 89 mL/min/1.73m²) compared to subjects with baseline normal renal function (eGFR ≥ 90 mL/ min/1.73m²). No dosage adjustment is necessary for patients with mild to moderate renal impairment. No data are available in patients with severe renal impairment or end-stage renal disease (eGFR ≤ 29 mL/min/1.73m²) (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: A dedicated hepatic impairment study compared the systemic exposure of apalutamide and N-desmethyl apalutamide in subjects with baseline mild or moderate hepatic impairment (Child-Pugh Class A or B, respectively) versus healthy controls with normal hepatic function. The systemic exposure of apalutamide and N-desmethyl apalutamide was similar in subjects with mild or moderate baseline hepatic impairment compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh Class C) (see Pharmacology: Pharmacokinetics under Actions).
Administration: Apalutamide (Erleada) should be administered orally once daily, with or without food. Swallow the tablets whole.