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Lyvelsa 10
Radiant Pharmaceuticals Ltd.
Generic: Finerenone
Medicine Overview of Lyvelsa 10mg tablet
বাংলা
English
Brief Description
Indications
Finerenone 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).
Pharmacology
Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone 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. Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen and glucocorticoid receptors. In patients treated with Finerenone, the mean systolic blood pressure decreased by 3 mmHg and the mean diastolic blood pressure decreased by 1-2 mmHg...
... Show moreDosage & Administration
The recommended starting dosage: 10 mg or 20 mg orally once daily based on estimated glomerular filtration rate (eGFR) and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds. Tablets may be taken with or without food.Recommended Dosage- eGFR ≥60 mL/min/1.73 m2: starting dose 20 mg once daily eGFR ≥25 to <60 mL/min/1.73 m2: starting dose 10 mg once daily eGFR <25 mL/min/1.73 m2: not recommended For patients who are unable to swallow whole tablets, Finerenone may be crushed and mixed with water or soft...
... Show moreInteraction
Strong CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Finerenone adverse reactions. Concomitant use of Finerenone with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.Moderate and Weak CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. 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.Strong...
... Show moreSide Effects
Adverse reactions occurring in ≥ 1% of patients on Finerenone and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.
Pregnancy & Lactation
There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. The clinical significance of these findings is unclear. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is...
... Show morePrecautions & Warnings
Finerenone can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for 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 with Finerenone 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.
Use in Special Populations
Pediatric Use: The safety and efficacy of Finerenone have not been established in patients below 18 years of age.Geriatric Use: Of the 2827 patients who received Finerenone in the FIDELIO-DKD study, 58% of patients were 65 years and older, and 15% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required. Hepatic Impairment: Avoid use of Finerenone in patients with severe hepatic impairment (Child Pugh C). No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B). Consider...
... Show moreOverdose Effects
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 given its fraction bound to plasma proteins of about 90%.
Therapeutic Class
Mineralocorticoid Receptor Antagonists
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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