KERENDIA 20 MG — DIN 02531925

What is KERENDIA?

KERENDIA 20 MG contains FINERENONE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02531925, held by BAYER INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Nov-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is KERENDIA used for?

KERENDIA (finerenone) is indicated as an adjunct to standard of care therapy in adults with 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, • Cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure. Heart Failure KERENDIA (finerenone) is indicated as an adjunct to standard of care in adults with heart failure with left ventricular ejection fraction (LVEF) ≥40% to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

For oral use, one tablet per day, at approximately the same time each day. For treatment of CKD and T2D, a daily dose of 20 mg of KERENDIA must not be exceeded. For treatment of heart failure with LVEF ≥40%, a daily dose of 40 mg of KERENDIA must not be exceeded. Tablets may be taken with a glass of water and with or without food. Avoid taking KERENDIA with grapefruit or grapefruit juice. For patients who are unable to swallow whole tablets, KERENDIA tablets may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally. A missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the dose should be skipped, and the next dose taken as prescribed. Two doses should not be taken to make up for a missed dose. CKD and T2D The starting dose of KERENDIA is: • 10 mg once daily if eGFR ≥ 25 to < 60 mL/min/1.73m² • 20 mg once daily if eGFR ≥ 60 mL/min/1.73m² Initiation of KERENDIA treatment is not recommended in patients with eGFR < 25 mL/min/1.73m² as clinical experience is limited. Initiation of KERENDIA treatment is not recommended in patients with serum potassium > 5.0 mmol/L. Initiation of KERENDIA treatment is recommended when serum potassium ≤ 4.8 mmol/L. If serum potassium > 4.8 to 5.0 mmol/L, initiation of KERENDIA treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels. For treatment of CKD and T2D the recommended target dose of KERENDIA is 20 mg once daily. Heart Failure The starting dose of KERENDIA is: • 10 mg once daily if eGFR ≥ 25 to < 60 mL/min/1.73m² • 20 mg once daily if eGFR ≥ 60 mL/min/1.73m² Initiation of KERENDIA treatment is not recommended in patients with eGFR < 25 mL/min/1.73m² as clinical experience is limited. Initiation of KERENDIA treatment is not recommended in patients with serum potassium > 5.0 mmol/L. Initiation of KERENDIA treatment is recommended when serum potassium ≤ 5.0 mmol/L. For treatment of heart failure with LVEF ≥40%, the recommended target dose of KERENDIA depends on renal function (eGFR) at initiation of KERENDIA treatment: • 40 mg once daily if eGFR ≥60 mL/min/1.73m² • 20 mg once daily if eGFR ≥25 to <60 mL/min/1.73m²

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

KERENDIA is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • who are receiving concomitant systemic treatment with medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone) • with Addison's disease

Warnings and precautions

Hyperkalemia (serum potassium > 5.5 mmol/L) can occur in patients with CKD and T2D and in patients with heart failure (LVEF ≥40%), and may be aggravated by therapy (e.g., ACEi, ARB, MRA or ARNI). KERENDIA can cause hyperkalemia. Some patients are at a higher risk to develop hyperkalemia. Risk factors include low eGFR, higher serum potassium and previous episodes of hyperkalemia. Consider more frequent monitoring in these patients. Although not observed in phase III studies with KERENDIA, hyperkalemia can, in rare cases, lead to serious, sometimes fatal arrhythmias. Initiation of KERENDIA treatment is not recommended if serum potassium > 5.0 mmol/L. Concomitant use of medications or grapefruit that affect finerenone exposure: Avoid concomitant use of KERENDIA with moderate CYP3A4 inducers (e.g., efavirenz, phenobarbital) or strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St John's Wort) which are expected to markedly decrease finerenone plasma concentrations and result in reduced therapeutic effect. Consider selection of an alternate concomitant medicinal product with no or weak potential to induce CYP3A4. Avoid concomitant intake of grapefruit or grapefruit juice as it is expected to increase the plasma concentration of finerenone. Renal: The risk of hyperkalemia increases with decreasing renal function. Ongoing monitoring of renal function should be performed as needed. Initiation of KERENDIA treatment is not recommended in patients with eGFR < 25 mL/min/1.73m² as clinical experience is limited. Continue KERENDIA treatment with caution regarding serum potassium levels in patients who have progressed to an eGFR < 25 mL/min/1.73m². Due to limited clinical experience, discontinue treatment in patients who have progressed to end-stage kidney disease (eGFR < 15 mL/min/1.73 m²). A greater risk of glomerular filtration rate decrease was observed in patients receiving KERENDIA treatment compared to placebo. In patients with heart failure, a greater risk of events related to worsening of renal function was observed in patients receiving KERENDIA treatment compared to placebo. Most of these events were mild to moderate in severity. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. Close monitoring of creatinine levels and eGFR should be considered during the treatment with KERENDIA in patients who develop clinically significant worsening of renal function.