Capivasertib

Source: UK SPC (eMC) §4.2 for Truqap 160 mg film-coated tablets (https://www.medicines.org.uk/emc/product/15838/smpc). VERBATIM: 'The recommended dose of Truqap in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily approximately 12 hours apart (total daily dose of 800 mg) with or without food, for 4 days followed by 3 days off treatment.' INDICATION/COMBINATION: HR-positive, HER2-negative advanced breast cancer, in patients selected on the presence of one or more PIK3CA/AKT1/PTEN alterations using a validated test; must be co-administered with fulvestrant — recommended fulvestrant dose is 500 mg intramuscularly on Days 1, 15 and 29 and once monthly thereafter (refer to the fulvestrant SmPC). In pre/perimenopausal women, combine with an LHRH agonist; for men, consider an LHRH agonist per current clinical practice. TREATMENT INITIATION: should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. MISSED DOSE: may be taken within 4 hours of the usual time; if more than 4 hours have passed, skip that dose and take the next at the usual time — there should be at least 8 hours between doses. If the patient vomits, do not take an additional dose. DOSE REDUCTIONS (maximum of two): first reduction 320 mg twice daily 4 days on / 3 days off (two 160 mg tablets); second reduction 200 mg twice daily 4 days on / 3 days off (one 200 mg tablet). CYP3A4: reduce the dose to 320 mg twice daily, 4 days on / 3 days off, when used concomitantly with strong or moderate CYP3A4 inhibitors. TOXICITY MANAGEMENT: the SPC gives graded dose-modification tables for hyperglycaemia (fasting glucose thresholds, withhold/reduce/discontinue, involve a diabetologist), diarrhoea, cutaneous adverse drug reactions and other toxicities — clinician to consult §4.2 Tables 3–6 in full; fasting glucose and HbA1C must be tested before and during treatment, and treatment must be interrupted immediately if DKA is suspected and permanently discontinued if DKA is confirmed. HEPATIC IMPAIRMENT: no adjustment in mild impairment; in moderate impairment (bilirubin >1.5x–3.0x ULN) give only if benefit outweighs risk with close monitoring; not recommended in severe impairment (bilirubin >3.0x ULN). ELDERLY: no dose adjustment; limited data aged ≥75 years. PAEDIATRIC: safety and efficacy in children aged 0–18 years have not been established. CROSS-CHECK (US labelling, openFDA/DailyMed, TRUQAP, label date 2026-06-12): same 400 mg twice daily 4 days on / 3 days off schedule, and additionally lists 400 mg twice daily in combination with abiraterone and prednisone for PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer — that indication is not in the UK SPC section fetched. The eMC §4.4 and §4.8 text was truncated at the source-fetch limit; clinician to verify against the full SPC.