finerenone

Absorption: 44% absorbed following oral administration.

Distribution: Widely distributed to tissues.

Protein Binding: 92%.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP3A4 isoenzyme and to a lesser extent by the CYP2C8 isoenzyme to inactive metabolites. Primarily excreted in the urine (80%) as metabolites, with 20% being excreted in feces.

Half-Life: 2–3 hr.

Time/Action Profile ⬆ ⬇

( plasma concentrations)

ROUTE		ONSET		PEAK		DURATION
PO		rapid		30 min–1.25 hr		unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Concurrent use of strong CYP3A4 inhibitors;
Adrenal insufficiency;
Hyperkalemia (serum potassium >5 mEq/L);
eGFR <25 mL/min/m²;
Severe hepatic impairment;
Lactation: Lactation.

Use Cautiously in:

Renal impairment (↑ risk of hyperkalemia) (adjust dose);
Moderate hepatic impairment;
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

F and E: hyperkalemia, hyponatremia

GU: renal impairment (in patients with HF)

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inhibitors may significantly ↑ levels and risk of hyperkalemia; concurrent use contraindicated.
Moderate CYP3A4 inhibitors, including erythromycin, or weak CYP3A4 inhibitors, including amiodarone, may ↑ levels and risk of hyperkalemia; closely monitor serum potassium levels after initiation of or after dosage adjustment of either the CYP3A4 inhibitor or finerenone.
Strong CYP3A4 inducers, including rifampin, or moderate CYP3A4 inducers, including efavirenz, may ↓ levels and effectiveness; avoid concurrent use.
Use with ACE inhibitors, NSAIDs, potassium supplements, angiotensin II receptor antagonists, potassium-sparing diuretics, angiotensin converting enzyme inhibitors, or cyclosporine↑ risk of hyperkalemia.

Drug-Food:

Grapefruit juice or grapefruit may ↑ levels and risk of hyperkalemia; avoid concurrent use.

Route/Dosage ⬆ ⬇

Chronic Kidney Disease Associated with Type 2 Diabetes

PO (Adults ): 20 mg once daily.

Renal Impairment

PO (Adults ): eGFR 25–<60 mL/min/m²: 10 mg once daily; after 4 wk, ↑ to 20 mg once daily if serum potassium ≤ 4.8 mEq/L.

Heart Failure with Left Ventricular Ejection Fraction 40%

PO (Adults ): 20 mg once daily; after 4 wk, ↑ to 40 mg once daily if serum potassium <5 mEq/L.

Renal Impairment

PO (Adults ): eGFR 25–<60 mL/min/m²: 10 mg once daily; after 4 wk, ↑ to 20 mg once daily if serum potassium <5 mEq/L.

Availability ⬆ ⬇

Tablets: 10 mg; 20 mg

Assessment ⬆ ⬇

Monitor for signs/symptoms of hyperkalemia (fatigue, muscle weakness, paresthesia, confusion, dyspnea, cardiac arrhythmias) during therapy. If symptoms occur, confirm with serum potassium.

Lab Test Considerations:

Measure potassium and eGFR before starting therapy, 4 wk after starting therapy, 4 wk after a dose adjustment, and periodically throughout treatment. Chronic Kidney Disease Associated with Type 2 Diabetes Serum potassium ≥5.5 mEq/L: Hold finerenone. If currently receiving 20 mg once daily, restart at 10 mg once daily when serum potassium ≤ 5 mEq/L. If currently receiving 10 mg once daily, consider restarting at 10 mg once daily when serum potassium ≤ 5 mEq/L. HF with LVEF ≥40%Serum potassium 5.5–<6 mEq/L: If currently receiving 40 mg once daily, ↓ to 20 mg once daily. If currently receiving 20 mg once daily, ↓ to 10 mg once daily. If currently receiving 10 mg once daily, hold finerenone and restart at 10 mg once daily once serum potassium <5.5 mEq/L. Serum potassium ≥6 mEq/L: Hold finerenone. Restart at 10 mg once daily when serum potassium <5.5 mEq/L. If repeated serum potassium measurements ≥5.5 mEq/L, restart at 10 mg once daily when serum potassium <5 mEq/L

Implementation ⬆ ⬇

PO: Administer without regard to food. For patients unable to swallow tablets whole, may crush tablets and mix with water or soft foods (applesauce) immediately before use.

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of finerenone. Instruct patient to take as directed. Take missed dose as soon as remembered, but only on same day. Do not double doses. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
Emphasize the importance of regular lab tests to monitor potassium levels.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Advise patients to consult with health care professional before using potassium supplements or salt substitutes containing potassium. Caution patient to avoid grapefruit and grapefruit juice during therapy; may ↑ the plasma concentration of finerenone.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 1 day after last dose.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction of the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal MI, and hospitalization for HF in patients with CKD associated with type 2 diabetes.
Reduction in the risk of cardiovascular death, hospitalization for HF, and urgent HF visits.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

12527- Bayer AG
- 12527-0541-
  - 12527-0541-9- 220588 TABLET, FILM COATED in 1 DRUM (12527-0541-9)

12527- Bayer AG
- 12527-0640-
  - 12527-0640-9- 220588 TABLET, FILM COATED in 1 DRUM (12527-0640-9)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-540- Kerendia
  - 50419-540-01- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-540- Kerendia
  - 50419-540-02- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-540- Kerendia
  - 50419-540-06- 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-540- Kerendia
  - 50419-540-70- 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-541- Kerendia
  - 50419-541-01- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-01)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-541- Kerendia
  - 50419-541-02- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-02)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-541- Kerendia
  - 50419-541-06- 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-541-06)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-541- Kerendia
  - 50419-541-70- 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-70)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-542- Kerendia
  - 50419-542-01- 30 TABLET in 1 BOTTLE, PLASTIC (50419-542-01)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-542- Kerendia
  - 50419-542-02- 90 TABLET in 1 BOTTLE, PLASTIC (50419-542-02)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-542-
  - 50419-542-05- 10 BLISTER PACK in 1 CARTON (50419-542-05) / 10 TABLET in 1 BLISTER PACK

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-542- Kerendia
  50419-542-06- 10 TABLET in 1 BLISTER PACK (50419-542-06)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-542- Kerendia
  - 50419-542-70- 7 TABLET in 1 BOTTLE, PLASTIC (50419-542-70)

50683- American Pacific Corporation
- 50683-0540-
  - 50683-0540-1- 1 kg in 1 DRUM (50683-0540-1)

70600- Maithri Drugs Private Limited
- 70600-059-
  70600-059-01- 50 kg in 1 DRUM (70600-059-01)

71973- Delpharm Milano Srl
- 71973-542-
  71973-542-01- 1 BOTTLE, PLASTIC in 1 CARTON (71973-542-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

71973- Delpharm Milano Srl
- 71973-542-
  71973-542-02- 1 BOTTLE, PLASTIC in 1 CARTON (71973-542-02) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

71973- Delpharm Milano Srl
- 71973-542-
  71973-542-70- 1 BOTTLE, PLASTIC in 1 CARTON (71973-542-70) / 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

72640- MSN Life Sciences Private Limited
- 72640-032-
  72640-032-01- 50 kg in 1 DRUM (72640-032-01)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇