Keren-dia Tablet 10mg (Finerenone)

Adult dose

Oral administration This medicine should be administered in combination with other standard therapies (including angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme (ACE) inhibitors). This medicine may be taken with water, with or without food. Avoid taking this medicine with grapefruit or grapefruit juice. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a beverage such as water or apple juice, and administered orally. 2.1 Chronic kidney disease associated with type 2 diabetes Initiation of treatment is recommended when serum potassium is ≤ 4.8 mmol/L. When 4.8 < serum potassium ≤ 5.0 mmol/L, initiation of treatment with this medicine may be considered, with additional serum potassium monitoring during the first 4 weeks according to the patient's characteristics and serum potassium level. Initiation of treatment with this medicine is not recommended when serum potassium > 5.0 mmol/L. For eGFR ≥ 60 mL/min/1.73m2, 20mg once daily For 25 ≤ eGFR < 60 mL/min/1.73m2, 10mg once daily Initiation of treatment with this medicine is not recommended in patients with eGFR < 25 mL/min/1.73m2. The recommended target dose is 20mg once daily. The maximum daily dose is 20mg. Re-measure serum potassium and eGFR 4 weeks after starting or restarting this medicine, or adjusting the dose. Serum potassium ≤4.8 mmol/L: Maintain 20mg once daily. Serum potassium ≤4.8 mmol/L: For patients taking 10mg once daily, increase the dose to 20mg once daily if the decrease in eGFR is <30% compared with the previous measurement. 4.8<serum potassium≤5.5: Maintain the dose. >5.5: Discontinue this medicine. When serum potassium is ≤5.0mmol/L, restart at 10mg once daily. 2.2 Chronic heart failure (LVEF ≥40%) Initiation of treatment is recommended when serum potassium is ≤ 5.0 mmol/L. For eGFR ≥ 60 mL/min/1.73m2, 20mg once daily For 25 ≤ eGFR < 60 mL/min/1.73m2, 10mg once daily Initiation of treatment with this medicine is not recommended in patients with eGFR < 25 mL/min/1.73m2. For eGFR ≥ 60 mL/min/1.73m2, 40mg once daily For 25 ≤ eGFR < 60 mL/min/1.73m2, 20mg once daily The maximum daily dose is 40mg. Re-measure serum potassium and eGFR 4 weeks after starting or restarting this medicine, or adjusting the dose. Serum potassium < 5.0: For patients taking 10mg once daily, increase the dose to 20mg once daily. Serum potassium < 5.0: For patients taking 20mg once daily, if eGFR at the start of treatment was < 60 mL/min/1.73m2: maintain 20mg once daily, Serum potassium < 5.0: For patients taking 20mg once daily, if eGFR at the start of treatment was ≥ 60 mL/min/1.73m2: increase the dose to 40mg once daily.* Serum potassium < 5.0: For patients taking 40mg once daily, maintain the dose. 5.0 ≤serum potassium< 5.5: Maintain the dose. 5.5 ≤serum potassium< 6.0: Reduce the dose by one dose level. 5.5 ≤serum potassium< 6.0: For patients taking 10mg once daily, discontinue treatment; when serum potassium is < 5.5 mmol/L, restart at 10mg once daily. ≥ 6.0: Discontinue this medicine. When serum potassium is < 5.5 mmol/L, restart at 10mg once daily.** *If the decrease in eGFR is <30% compared with the previous measurement **If repeated measurements are ≥ 5.5 mmol/L, restart at 10mg once daily when <5.0mmol/L. If a dose is missed, it should be taken as soon as the patient remembers, but only if it is the same day. Otherwise, the missed dose should be skipped and the next dose taken as prescribed. A double dose should not be taken to make up for a missed dose. Patients with renal impairment: The starting dose of this medicine in patients with 25 ≤ eGFR < 60 mL/min/1.73m2 is 10mg once daily. Initiation of treatment with this medicine is not recommended in patients with eGFR < 25 mL/min/1.73m2 because clinical experience is limited. In patients with renal impairment and eGFR ≥ 15 mL/min/1.73m2, continue treatment with this medicine and adjust the dose according to serum potassium. Measure eGFR 4 weeks after starting treatment to determine whether to uptitrate. Discontinue this medicine in patients who progress to end-stage kidney disease (eGFR < 15 mL/min/1.73m2) because clinical experience is limited. Patients with hepatic impairment: Avoid this medicine in patients with severe hepatic impairment (Child Pugh C). No adjustment of the starting dose is required in patients with mild or moderate hepatic impairment (Child Pugh A or B). In patients with moderate hepatic impairment (Child Pugh B), consider additional serum potassium monitoring and adjust monitoring according to the patient's characteristics. Patients taking concomitant medications: For patients taking this medicine concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim-sulfamethoxazole, consider additional serum potassium monitoring, adjust monitoring according to the patient's characteristics, and determine whether to administer this medicine according to Table 1 or 2. Temporary discontinuation of this medicine may be necessary when taking trimethoprim or trimethoprim/sulfamethoxazole.

This medication should not be taken by those who are allergic to specific ingredients. Additionally, it should not be combined with certain strong medications, so it is essential to inform your healthcare provider about any medications you are currently taking. Individuals with a condition known as Addison's disease should also refrain from using this medication. This medication contains lactose, thus those with lactose intolerance or related genetic disorders should exercise caution. Individuals with elevated potassium levels or poor kidney function must be particularly careful when using this medication and should regularly check potassium levels and kidney function through blood tests. Specifically, it is advised not to initiate this medication if serum potassium exceeds 5.0 mmol/L. Patients with chronic heart failure or kidney disease associated with diabetes may need to monitor potassium levels more frequently and adjust medication dosage as necessary. Patients with severe liver dysfunction should avoid using this medication, and those with moderate liver impairment should check potassium levels regularly. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should employ adequate contraception to prevent pregnancy. This medication can worsen kidney function in patients with chronic heart failure, so regular kidney function tests are necessary before and during treatment. While taking this medication, patients should be alert for possible side effects such as hyperkalemia, hypotension, hyperuricemia, worsening kidney function, and anemia; regular monitoring is required. Hyperkalemia, which is commonly seen with elevated potassium levels, necessitates frequent monitoring of potassium levels. This medication may interact with other medications, so inform your healthcare provider of any concurrent medications, particularly potassium-sparing diuretics or certain antibiotics, as caution is necessary when used together. Avoid consuming grapefruit or grapefruit juice as it may increase the blood concentration of this medication. In case of overdose, stop taking the medication immediately and consult a healthcare provider, as hyperkalemia symptoms may occur.

• Hyperkalemia
• hyponatremia
• hyperuricemia
• hypotension
• pruritus
• increased serum creatinine
• reduced glomerular filtration rate
• decreased hemoglobin
• syncope
• dizziness

This medication should be stored in a tightly closed container to prevent air and moisture penetration, at a temperature between 1 and 30 degrees Celsius. Storing this product in this manner will help maintain its effectiveness for a longer period.

Appearance

Pink oblong film-coated tablet

Package unit

For domestic use - 28 tablets/box [(14 tablets/blister x 2)], For domestic use - 98 tablets/box [(14 tablets/blister x 7)]