Finerenone

SCOPE: this draft covers ONLY the page's indication — chronic kidney disease associated with type 2 diabetes (T2D). The same SPC also carries a heart failure (LVEF ≥ 40%) indication with a HIGHER target and maximum (up to 40 mg once daily); none of those figures are used here. || SPC §4.2 verbatim (CKD with T2D): 'The recommended target dose is 20 mg finerenone once daily. The maximum recommended dose is 20 mg finerenone once daily.' INITIATION: 'Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated ... and to determine the starting dose. If serum potassium ≤ 4.8 mmol/L, finerenone treatment can be initiated. If serum potassium > 4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels. If serum potassium > 5.0 mmol/L, finerenone treatment should not be initiated.' STARTING DOSE — Table 1 exactly as fetched: 'eGFR (mL/min/1.73 m2) ≥ 25 to < 60 → 10 mg once daily; < 25 → Not recommended'. ⚠ PROVENANCE OF THE eGFR ≥ 60 BAND: the fetched UK Table 1 for the CKD-with-T2D indication contains NO row for eGFR ≥ 60 — it lists only the two rows above. The eGFR ≥ 60 starting dose in the dose field is taken from the US FDA label's Table 1, which reads '≥ 60 → 20 mg orally once daily'. It is included because omitting it would leave 10 mg as the only starting dose on the page and would under-dose the commonest eligible group by half; it is attributed to the US label in the dose line rather than presented as UK text. Confirm Table 1 against the full UK SPC before release. CONTINUATION — Table 2 (CKD with T2D), verbatim: on 10 mg once daily, potassium ≤ 4.8 mmol/L 'Increase to 20 mg finerenone once daily' (table footnote: 'maintain 10 mg once daily, if eGFR has decreased > 30% compared to the previous measurement'); '> 4.8 to 5.5 → Maintain 10 mg once daily'; '> 5.5 → Withhold finerenone. Consider re-starting at 10 mg once daily when serum potassium ≤ 5.0 mmol/L.' On 20 mg once daily: '≤ 4.8 → Maintain 20 mg once daily'; '> 4.8 to 5.5 → Maintain 20 mg once daily'; '> 5.5 → Withhold finerenone. Re-start at 10 mg once daily when serum potassium ≤ 5.0 mmol/L.' MISSED DOSE: 'A missed dose should be taken as soon as the patient notices, but only on the same day. The patient should not take 2 doses to make up for a missed dose.' ELDERLY (≥ 65 years): 'No dose adjustment is necessary in elderly patients ... but regular monitoring of renal function is recommended.' BODY WEIGHT: 'No dose adjustment is necessary based on body weight.' CONCOMITANT MEDICINES: 'In patients taking finerenone concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim/sulfamethoxazole, additional serum potassium monitoring and adaptation of monitoring according to patient characteristics should be considered ... Temporary discontinuation of finerenone may be necessary, when patients have to take trimethoprim, or trimethoprim/sulfamethoxazole.' PAEDIATRIC: 'The safety and efficacy of finerenone in children and adolescents aged under 18 years have not yet been established. No data are available.' (US §8.4: 'The safety and efficacy of Kerendia have not been established in patients below 18 years of age.') ADMINISTRATION: 'Oral use. Tablets may be taken with a glass of water and with or without food ... Tablets should not be taken with grapefruit or grapefruit juice ... For patients who are unable to swallow whole tablets, Kerendia tablets may be crushed and mixed with water or soft foods, such as apple sauce, directly before oral use.' FORMS (US §3): 'Tablets: 10 mg, 20 mg, and 40 mg'. PAGE CHECK (finerenone_ckd, category 'CKD Nephroprotection', renal): the page's primary indication is CKD nephroprotection in diabetic kidney disease, which is exactly what the quoted SPC posology doses, so the dose above is on-indication. The page's existing 'increase to 20 mg once daily after 4 weeks if K+ < 5.0 mmol/L' is looser than the SPC threshold, which is ≤ 4.8 mmol/L.