There are updates throughout the SPC with the following sections implicated:
Section 4.1 Therapeutic indications
Addition of new indication for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
Section 4.2 Posology
Added: Medical castration with an LHRH analogue should be continued during treatment of patients not surgically castrated.
Section on Paediatric population updated
4.8 Undesirable effects
Updates throughout this section resulting from new data. Updated information on risk of seizure.
5.1 Pharmacodynamic properties
Clinical efficacy and safety
Information on the Prevail study added.
Older people: Of the 1671 patients in the phase 3 trials who received enzalutamide, 1261 patients (75%) were 65 years and over and 516 patients (31%) were 75 years and over. No overall differences in safety or effectiveness were observed between these older patients and younger patients.
10. Date of Revision of the Text
Changed to November 2014