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Non-Steroidal Selective Mineralocorticoid Receptor Antagonist (MRA) — CKD in T2DM Pregnancy: Contraindicated — potential fetal harm via MR blockade; effective contraception required

Finerenone

Brand names: Kerendia

Adult dose

Dose: eGFR ≥60: 20 mg once daily; eGFR 25–<60: 10 mg once daily; check serum potassium before starting — withhold if K+ >5.0 mmol/L
Route: Oral
Frequency: Once daily with or without food
Max: 20 mg once daily
Reassess serum potassium at 4 weeks: if K+ ≤4.8 mmol/L AND eGFR ≥60 → uptitrate from 10 mg to 20 mg; if K+ >5.5 mmol/L — withhold and restart at lower dose when K+ normalises; MHRA approved March 2022; NICE TA877 (2023) recommends finerenone for CKD with T2DM with UACR ≥200 mg/g and eGFR ≥25

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not licensed under 18 years
No paediatric indication

Dose adjustments

Renal

Start at 10 mg if eGFR 25–<60; 20 mg if eGFR ≥60; avoid if eGFR <25 (limited data and hyperkalaemia risk); monitor closely

Hepatic

Avoid in severe hepatic impairment (Child-Pugh C); use with caution in moderate impairment — increased finerenone exposure

Clinical pearls

  • Non-steroidal selectivity advantage: finerenone is a third-generation non-steroidal MRA — its bulkier molecular structure produces a different receptor conformation to steroidal MRAs (spironolactone, eplerenone); achieves high mineralocorticoid receptor selectivity with minimal androgen and progesterone receptor activity; this explains the absence of gynaecomastia and sexual side effects that limit spironolactone use (particularly in men)
  • FIDELIO-DKD (NEJM 2020): 5,734 patients with CKD + T2DM on maximum RAS blockade; finerenone reduced composite kidney endpoint (40% eGFR reduction, kidney failure, kidney death) by 18% (HR 0.82) and cardiovascular events by 14%; landmark trial establishing CKD benefit beyond RAAS blockade alone
  • FIGARO-DKD (NEJM 2021): 7,437 patients (earlier stage DKD); finerenone reduced cardiovascular events (death, MI, stroke, heart failure hospitalisation) by 13%; combined FIDELIO + FIGARO analysis (FIDELITY) confirmed both cardiovascular and kidney protection across the spectrum of DKD
  • NICE TA877 (2023): recommended alongside ACE inhibitor/ARB (at maximum tolerated dose) in adults with CKD and T2DM with UACR ≥200 mg/g and eGFR ≥25 — triple therapy for CKD protection in T2DM (RAAS blocker + SGLT-2 inhibitor + finerenone) is now the evidence-based standard
  • Hyperkalaemia management algorithm: check K+ before starting; if K+ >5.0 — do not start; recheck after diuretic optimisation or dietary potassium reduction; after starting, check K+ at 4 weeks and with any dose change; when K+ rises, consider temporary dose reduction rather than permanent discontinuation — FIDELIO-DKD showed patients who resumed finerenone after hyperkalaemia interruption still derived benefit

Contraindications

  • Serum potassium >5.0 mmol/L at initiation
  • Severe hepatic impairment (Child-Pugh C)
  • Concomitant strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, clarithromycin, ritonavir)
  • Addison's disease (primary adrenal insufficiency)
  • eGFR <25 mL/min (avoid — limited data)

Side effects

  • Hyperkalaemia (most important — ~14% vs 7% placebo in FIDELIO-DKD)
  • Hypotension
  • Hyponatraemia
  • NO gynaecomastia (key advantage over spironolactone)
  • NO sexual dysfunction (key advantage over spironolactone)
  • Headache
  • Dizziness

Interactions

  • Strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, clarithromycin) — absolute contraindication; massive finerenone exposure increase
  • Moderate CYP3A4 inhibitors (diltiazem, verapamil, amiodarone, erythromycin) — avoid or use with caution; monitor potassium
  • ACE inhibitors/ARBs — additive hyperkalaemia risk; monitor K+ closely
  • NSAIDs — reduced renal function and hyperkalaemia risk
  • Grapefruit juice — CYP3A4 inhibition; avoid

Monitoring

  • Serum potassium at baseline, 4 weeks after starting/titrating, then 3-monthly
  • eGFR and serum creatinine at baseline and regularly
  • Blood pressure
  • UACR (albuminuria response to treatment)
  • Signs of adrenal insufficiency if combined with other adrenal-suppressing agents

Reference: BNFc; BNF 90; MHRA Approval Kerendia March 2022; NICE TA877 (2023); Bakris et al. NEJM 2020 (FIDELIO-DKD); Pitt et al. NEJM 2021 (FIGARO-DKD); FIDELITY pooled analysis EJHF 2022; SPC Kerendia. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.