Finerenone
Regulatory sources consulted
Approved indications
- Treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, clarithromycin).
- Addison's disease.
Clinical warnings
- Major warning · Hyperkalemia: Finerenone can cause hyperkalemia. Serum potassium monitoring is required before initiation, during treatment, and upon dose adjustment. The risk increases with decreasing renal function and with concomitant use of other drugs that increase potassium. — AEMPS CIMA
Drug interactions
- HighStrong CYP3A4 inhibitors (e.g., Ketoconazole)J02AB02
Mechanism: Inhibition of finerenone metabolism via CYP3A4, drastically increasing its exposure and risk of toxicity.
Recommendation: Concomitant use is contraindicated.
AEMPS CIMA
- HighGrapefruit juice
Mechanism: Inhibition of intestinal CYP3A4, increasing finerenone exposure.
Recommendation: Avoid intake of grapefruit or grapefruit juice during treatment with finerenone.
AEMPS CIMA
- ModerateModerate CYP3A4 inhibitors (e.g., Erythromycin)J01FA01
Mechanism: Inhibition of finerenone metabolism via CYP3A4, increasing its exposure and the risk of hyperkalemia.
Recommendation: Monitor serum potassium, especially at initiation or when changing the dose, and consider a dose adjustment of finerenone.
AEMPS CIMA
Adverse events
Common (≥1%)
hyperkalemia · hyponatremia · hypotension · glomerular filtration rate decreased · pruritus
Rare but serious
severe hyperkalemia
Pregnancy and lactation
Pregnancy: Finerenone should not be used during pregnancy unless the benefit to the mother outweighs the risk to the fetus. Lactation: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from finerenone therapy.
Recent literature (PubMed)
Revisión que destaca el mecanismo de acción dual de finerenona (antiinflamatorio y antifibrótico) como complemento a los bloqueadores del SRAA y los iSGLT2 para ralentizar la progresión de la enfermedad renal crónica en pacientes con diabetes, basándose en los resultados de ensayos clínicos recientes.