Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Posology: The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Medical castration with 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 on the same day with a return to the normal schedule the following day. Extra tablets should not be taken to make up the missed dose.
If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted. For the most common adverse reactions, see Adverse Reactions.
Special populations: Elderly: No dose adjustment is necessary for elderly patients (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment.
Caution is required in patients with severe renal impairment as apalutamide has not been studied in this patient population (see Pharmacology: Pharmacokinetics under Actions). If treatment is started, patients should be monitored for the adverse reactions listed in Adverse Reactions and dose reduce as per Dosage & Administration
Hepatic impairment: No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).
ERLEADA is not recommended in patients with severe hepatic impairment as there are no data in this patient population and apalutamide is primarily hepatically eliminated (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of apalutamide in the paediatric population in the treatment of non-metastatic castration-resistant prostate cancer.
Method of administration: Oral use.
The tablets should be swallowed whole and can be taken with or without food.