Prescribing Details
Description
Fincor® is a preparation of Finerenone. It is a nonsteroidal, selective antagonist of the mineralocorticoid receptor
(MR), which is activated by aldosterone and cortisol and regulates gene transcription. Fincor ® blocks MR
mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart
and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Fincor ® has a
high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen and
glucocorticoid receptors.
Uses
No Data
Indications
Fincor® is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular
death, nonfatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney
disease (CKD) associated with type 2 diabetes (T2D).
Dosage and administration
Route of administration: Fincor® should be taken in oral route.
Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Treatment
should not be initiated if serum potassium is > 5.0 mEq/L. For patients who are unable to swallow whole tablets,
Fincor ® may be crushed and mixed with water or soft foods immediately prior to use and administered orally.
Recommended starting dosage
The recommended starting dose of Fincor® based on eGFR is presented in Table-1.
Table-1: Recommended starting dosage
| Table-1: Recommended starting dosage | |
|---|---|
| eGFR (ml/min/1.73m²) | Starting dose |
| ≥ 60 | 20 mg once daily |
| ≥ 25 to < 60 | 10 mg once daily |
| < 25 | Initiation is not recommended |
Monitoring and dose adjustment
The target daily dose of Fincor ® is 20 mg. Measure serum potassium 4 weeks after initiating treatment and adjust
dose (see Table-2); if serum potassium levels are > 4.8 to 5.0 mEq/L, initiation of Fincor ® treatment may be
considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgement and
serum potassium levels. Monitor serum potassium 4 weeks after a dose adjustment and throughout treatment and
adjust the dose as needed (see Table-2).
| Table-2: Dose adjustment based on current serum potassium concentration and current dose | |||
|---|---|---|---|
| Current Fincor dose | |||
| 10 mg once dally | 20 mg once dally | ||
| Current serum potassium (mEq/L) | ≤ 4.8 | Increase the dose to 20 mg once daily.* | Maintain 20 mg once daily. |
| > 4.8 – 5.5 | Maintain 10 mg once daily. | Maintain 20 mg once daily. | |
| > 5.5 | Withhold Fincor ®. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. |
Withhold Fincor ®. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. |
|
| * If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose. | |||
Missed doses
Direct a patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is
not possible, the patient should skip the dose and continue with the next dose as prescribed.
Hepatic impairment
Avoid use of Fincor ® in patients with severe hepatic impairment. No dosage adjustment is recommended in
patients with mild or moderate hepatic
Use in pregnancy & lactation
Pregnancy: There are no available data on finerenone use in pregnancy to evaluate for a drug-associated risk of
major birth defects, miscarriage or adverse maternal or fetal outcomes.
Lactation: 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. Because of the potential risk to breastfed infants
from exposure to finerenone, avoid breastfeeding during treatment and for 1 day after treatment.
Use in children and adolescents
The safety and efficacy of finerenone have not been established in patients below 18 years of age.
Geriatric use
Precautions
Warning and precaution
Finerenone can cause hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of
treatment with finerenone and dose accordingly. Do not initiate finerenone if serum potassium is > 5.0 mEq/L.
Measure serum potassium periodically during treatment and adjust dose accordingly. More frequent monitoring
may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair
potassium excretion or increase serum potassium.
Side effects
The most common side effects are hyperkalemia, hypotension and hyponatremia.
Contraindications
Finerenone is contraindicated in patients with known hypersensitivity to finerenone or any other components of
this product. It is also contraindicated in patients receiving concomitant treatment with strong CYP3A4 inhibitors
and in patients with adrenal insufficiency.
Drug interactions
Drug interaction with medication: Finerenone is a CYP3A4 substrate. Concomitant use of finerenone with strong
CYP3A4 inhibitors is contraindicated. Concomitant use with a moderate or weak CYP3A4 inhibitor increases
finerenone exposure, which may increase the risk of finerenone adverse reactions. Monitor serum potassium
during drug initiation or dosage adjustment of either finerenone or the moderate or weak CYP3A4 inhibitor and
adjust finerenone dosage as appropriate. Concomitant use of finerenone with a strong or moderate CYP3A4
inducer decreases finerenone exposure, which may reduce the efficacy of finerenone. Avoid concomitant use of
finerenone with strong or moderate CYP3A4 inducers. More frequent serum potassium monitoring is warranted in
patients receiving concomitant therapy with drugs or supplements that increase serum potassium.
Drug interaction with food & others: Avoid concomitant intake of grapefruit or grapefruit juice.
Overdose
In the event of suspected overdose, immediately interrupt finerenone treatment. The most likely manifestation of
overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated. Finerenone is
unlikely to be efficiently removed by hemodialysis.
Preparation
No Data
Pharmaceutical precautions
No Data
Presentation
Composition
Fincor ® 10 tablet: Each coated tablet contains Finerenone INN 10 mg.
Fincor ® 20 tablet: Each coated tablet contains Finerenone INN 20 mg.
Package quantities
Storage
Store in a cool (below 30⁰C) & dry place protected from the light. Keep away from the reach of children.
Packing
Fincor ® 10 tablet: Carton of 20 tablets in blister pack.
Fincor ® 20 tablet: Carton of 10 tablets in blister pack.
