Bicalutamide

SOURCE: eMC UK SPC, productName 'Bicalutamide 150 mg film-coated Tablets' (https://www.medicines.org.uk/emc/product/101113/smpc), §4.2 — the same SPC as the general bicalutamide entry; this is the urology-context listing. VERBATIM: 'Adult males including older people: the dosage is one 150mg film-coated tablet to be taken orally once a day. Bicalutamide should be taken continuously for at least 2 years or until disease progression.' PAGE SCOPE WARNING: a urology listing is normally expected to cover BOTH bicalutamide regimens — 150 mg once daily as monotherapy AND 50 mg once daily with a GnRH/LHRH analogue for combined androgen blockade or flare cover. Only the 150 mg monotherapy SPC was fetched in this bundle, so only that regimen is asserted above. The 50 mg regimen appears here solely in the US prescribing information fetched in this bundle (bicalutamide, Proficient Rx LP, DailyMed, 2024-03-01): 'The recommended dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food', started at the same time as the LHRH analogue. That is US labelling and the corresponding UK SPC for the 50 mg product was NOT fetched — source it before publishing a combined-blockade dose. The two regimens differ threefold, so confirm which indication and strength applies before acting on this page. INITIATION should be under the direct supervision of a specialist. For patients who have objective progression of disease together with elevated PSA, cessation of bicalutamide therapy should be considered. HEPATIC: no dose adjustment for mild hepatic impairment; increased accumulation may occur in moderate to severe hepatic impairment, so use with caution and consider periodic liver function testing (the majority of changes are expected within the first 6 months) and discontinue if changes are severe. PHOTOSENSITIVITY (§4.4, reported for the 150 mg strength): advise patients to avoid direct exposure to excessive sunlight or UV light and consider sunscreens. CONTRACEPTION: patients and/or their partners should follow adequate contraception during, and for 130 days after, bicalutamide therapy. PAEDIATRIC: bicalutamide is contraindicated for use in children (§4.3), hence paedDose is null. SOURCE NOTE: the eMC §4.5 was not captured in this bundle (the §4.4 text is truncated at the source-fetch limit) — the interactions below are drawn from eMC §4.3 and §4.4 and from the US label §7, each marked with its provenance; review the full §4.5 in the SPC.