Slide 1: US FDA prescribing information for finerenone
Date of preparation: July 2025 Global Job Code: MA-M_FIN-ALL-2043-1 Local Job Code: MA-M_FIN-ES-0363-1 US FDA prescribing information for finerenone ▼ Overview of US FDA-approved prescribing information for use in adult patients with HF LVEF ≥40% ▼ This medicinal product is subject to additional mon
Slide 2: Content overview
Content overview Indications and usage Adverse reactions Dosage and administration Drug interactions Dosage forms and strengths Use in specific populations Overdosage Contraindications Patient counseling info Warnings and precautions 2 Finerenone in Spain is indicated in adults for the treatment of
Slide 3: Finerenone summary of practical use guide for HF LVEF ≥40%
Finerenone Summary of practical use guide for the management of HF LVEF ≥40% based on the US FDA label Adult patients with Serum [K+] ≤5.0 eGFR ≥25 INDICATION HF LVEF ≥40%* mEq/L mL/min/1.73 m2 DOSE INITIATION DOSE ADJUSTMENT Do not initiate treatment if: Measure serum [K+] and eGFR 4 weeks after in
Slide 4: Finerenone indication in adult patients with HF and LVEF ≥40%
Finerenone indication in adult patients with HF and LVEF ≥40% Finerenone is indicated to reduce the risk of: Cardiovascular death Hospitalization for HF Urgent HF visits HF, heart failure; LVEF, left ventricular ejection fraction. 4 Finerenone Prescribing Information. 2025. https://www.accessdata.fd
Slide 5: Initiation and target dose
Initiation and target dose Serum potassium Before initiation Do not initiate if serum [K+] is >5.0 mEq/L or measure: eGFR is <25 mL/min/1.73 m2 eGFR eGFR <25 mL/min/1.73 m2 eGFR ≥25 to <60 mL/min/1.73 m2 eGFR ≥60 mL/min/1.73 m2 HF (LVEF ≥40%) 10 20 20 40 Initiation dose is based Not on eGFR (mL/min/
Slide 6: Dose adjustment and titration
Dose adjustment and titration Finerenone dose adjustments should be made based on the patient’s current dose, serum potassium concentration, and eGFR Current serum [K+] Current dose HF (LVEF ≥40%) (mEq/L) 10 mg qd 20 mg qd 40 mg qd 10 20 20 40 Measure serum [K+] and <5.0 Maintain 40 mg qd Increase t
Slide 7: Guidance for serum potassium and eGFR monitoring
Guidance for serum potassium and eGFR monitoring Measure serum potassium levels and eGFR before initiating finerenone Serum potassium: • >5.0 mEq/L at initiation: do not initiate treatment Click here for further eGFR: initiation guidance • <25 mL/min/1.73 m2 at initiation: do not initiate treatment
Slide 8: Method of administration
Method of administration Finerenone tablets may be taken with a glass of water 10 20 40 Finerenone tablets may be crushed and mixed with water or Finerenone tablets can be soft foods immediately before taken with or without food administration for patients unable to swallow whole tablets 11 Finereno
Slide 9: Recommendation for missed doses
Recommendation for missed doses 10 20 A missed dose should be taken as soon as the patient notices, but only on the same day 40 If this is not possible, the patient should skip the dose and continue with the next dose as prescribed 12 Finerenone Prescribing Information. 2025. https://www.accessdata.
Slide 10: Finerenone is available in film-coated, oblong tablets in three different strengths
Finerenone is available in film-coated, oblong tablets in three different strengths 10 10 mg: pink, with “FI” on one side and “10” on the other side 20 mg: yellow, with “FI” on one side and “20” on the other side 20 40 mg: grey-orange, with “FI” on one side and “40” on the other side 40 13 Finerenon
Slide 11: Contraindications
Contraindications Finerenone is contraindicated in patients … … who are hypersensitive to any component of this product … receiving concomitant treatment with strong CYP3A4 inhibitors … with adrenal insufficiency CYP3A4, cytochrome P450 3A4. 14 Finerenone Prescribing Information. 2025. https://www.a
Slide 12: Warnings and precautions
Warnings and precautions Finerenone can cause Measure serum potassium and The risk of hyperkalemia hyperkalemia eGFR in all patients before is higher in patients with treatment initiation and dose K+ higher The risk baseline potassium increases levels with serum for developing hyperkalemia and kidne
Slide 13: Adverse reactions
Adverse reactions • Safety data from 2993 patients with HF LVEF ≥40% treated with finerenone (10, 20, or 40 mg qd) were collected from FINEARTS-HF – a randomized, double-blind, placebo-controlled, multicenter, pivotal phase III study: the mean duration of treatment was 2.3 years • The overall safety
Slide 14: Drug interactions: finerenone and strong CYP3A4 inhibitors
Drug interactions: finerenone and strong CYP3A4 inhibitors As a CYP3A4 substrate, finerenone interacts with both CYP3A4 inhibitors and inducers Strong CYP3A4 inhibitors Strong and moderate CYP3A4 inducers Concomitant use of finerenone with a strong CYP3A4 Concomitant use of finerenone with a strong
Slide 15: Drug interactions: finerenone and CYP2C8 substrates
Drug interactions: finerenone and CYP2C8 substrates Finerenone, at 40 mg dose, is a If finerenone 40 mg is co-administered with CYP2C8 substrates, monitor patients more weak inhibitor of CYP2C8 and can frequently for adverse reactions* as even increase exposure to CYP2C8 small increases in concentra
Slide 16: Drug interactions: finerenone and drugs affecting serum potassium
Drug interactions: finerenone and drugs affecting serum potassium More frequent serum potassium monitoring is warranted in patients receiving concomitant therapy with drugs or supplements that increase serum potassium Guidance for serum potassium monitoring 20 Finerenone Prescribing Information. 202
Slide 17: Use in special populations: pregnancy and lactation
Use of finerenone in special patient populations: pregnancy and lactation • Animal studies have shown Pregnant women developmental toxicity at exposures • There are no data of finerenone use in pregnancy to ~2x those expected in humans evaluate for drug-associated risk of major birth defects, • The
Slide 18: Special populations: age and hepatic impairment
Use of finerenone in special patient populations: age and patients with hepatic impairment Pediatric use Geriatric use The safety and efficacy of finerenone has not No overall differences in safety or efficacy were been established in patients younger than observed between younger and elderly patien
Slide 19: Managing finerenone overdose
Managing finerenone overdose In the event of suspected overdose, immediately interrupt finerenone treatment K+ Hyperkalemia is the Standard treatment Hemodialysis is unlikely most likely manifestation should be initiated to efficiently remove of overdose if hyperkalemia develops finerenone given it
Slide 20: Patient counseling for the use of finerenone
Patient counseling for the use of finerenone Minimize hyperkalemia risk K+ • Advise patients receiving finerenone of the need for periodic monitoring of serum potassium levels − Mention the importance of consulting with their physician before using potassium supplements or salt substitutes containin