Drug profile
Finerenone
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR
and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for
CKD and T2DM based on eGFR and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once
daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The safety and efficacy of Kerendia have not been established in patients below 18
years of age.
Source: US FDA label for finerenone (Kerendia), section 'pediatric use', retrieved
2026-08-29
RENAL IMPAIRMENT
- The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR
and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for
CKD and T2DM based on eGFR and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once
daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds.
Source: US FDA label for finerenone (Kerendia), section 'dosage and
administration', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No dose adjustment is required. 8.6 Hepatic Impairment Avoid use of Kerendia in
patients with severe hepatic impairment (Child Pugh C).
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29
- No dosage adjustment is recommended in patients with mild or moderate hepatic
impairment (Child Pugh A or B).
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29
- Consider additional serum potassium monitoring in patients with moderate hepatic
impairment (Child Pugh B) [see Dosing and Administration (2.3) and Clinical
Pharmacology (12.3) ].
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY
- Risk Summary There are no available data on Kerendia use in pregnancy to evaluate
for a drug-associated risk of major birth defects, miscarriage, or adverse
maternal or fetal outcomes.
Source: US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved
2026-08-29
- Animal studies have shown developmental toxicity at exposures about 2 times those
expected in humans (see Data ) .
Source: US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved
2026-08-29
- The clinical significance of these findings is unclear.
Source: US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Lactation: Breastfeeding not recommended ( 8.2 ) 8.1 Pregnancy Risk Summary There
are no available data on Kerendia use in pregnancy to evaluate for a drug-
associated risk of major birth defects, miscarriage, or adverse maternal or fetal
outcomes.
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29
- When rats were exposed during pregnancy and lactation in the pre- and postnatal
developmental toxicity study, increased pup mortality and other adverse effects
(lower pup weight, delayed pinna unfolding) were observed at about 2 or 4 times
the AUC unbound expected in humans at the dose of 40 mg and 20 mg, respectively.
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29
- The dose free of findings provides a safety margin of about 2 times for the AUC
unbound expected in humans for the 20 mg dose and is in the therapeutic range for
the 40 mg dose. 8.2 Lactation Risk Summary There are no data on the presence of
finerenone or its metabolite in human milk, the effects on the breastfed infant or
the effects of the drug on milk production.
Source: US FDA label for finerenone (Kerendia), section 'use in specific
populations', retrieved 2026-08-29