Product Details

Kerendia

Finerenone
10 mg
Tablet


DIN/PIN/NPN

02531917

Manufacturer

Bayer Inc., Health Care Division

Formulary Listing Date

2024-03-28  

Unit Price

3.2565

Amount MOH Pays

3.2565

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C03DA05

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
700 1 year

For use as an adjunct to standard-of-care (SOC) therapy in adult patients diagnosed with BOTH chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in patients who meet the following criteria:

  1. 18 years of age or older; AND

  2. Diagnosed with CKD with an eGFR level greater than or equal to 25mL/min/1.73 square metres AND an albuminuria level greater than or equal to 30mg/g (or 3mg/mmol); AND

  3. Patient is also diagnosed with T2D; AND

  4. Finerenone is prescribed in addition to standard-of-care (SOC)* therapy for patients diagnosed with CKD with comorbid T2D; AND

    *SOC therapy is defined as maximally tolerated doses of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy in combination with a sodium-glucose cotransporter-2 (SGLT2) inhibitor unless SGLT2 inhibitors are contraindicated or not tolerated.

  5. Patient does not have a diagnosis of chronic heart failure (CHF) with reduced ejection fraction and persistent symptoms meeting New York Heart Association Class II to IV; AND

  6. Patient is not using finerenone in combination with another mineralocorticoid receptor antagonist (MRA); AND

  7. Finerenone is prescribed in consultation with a nephrologist or other clinician with experience in the diagnosis and management of patients with CKD and T2D.

Discontinuation Criteria:

Patients meeting the initiation criteria and started on finerenone should be discontinued on treatment if the patient's eGFR is less than 15mL/min/1.73 square metres and/or if the urinary albumin-to-creatinine ratio (UACR) has increased from baseline level after starting treatment with finerenone.

Approved Dosage:

- 20mg once daily for patients with an eGFR of at least 60mL/min/1.73 square metres

OR

- 10mg once daily for patients with an eGFR of at least 25mL/min/1.73 square metres to less than 60mL/min/1.73 square metres

 

EAP Criteria

NO

Product Monograph

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