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Fineron10 mg
Everest Pharmaceuticals Ltd.
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Firendia10 mg
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Medicine overview
Indications of Firendia 10 mg
Firendia 10 mg is indicated to reduce the risk of sustained eGFR declineend-stage kidney diseasecardiovascular deathnon-fatal myocardial infarction
Dosage of Firendia 10 mg
Prior to Initiation of Kerendia
Dosage:Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation
Notes:Do not initiate treatment if serum potassium is >5.0 mEq/L
Recommended Starting Dosage
Dosage:The recommended starting dose of Kerendia is based on eGFR
Notes:≥60 eGFR (mL/min/1.73 m2): Starting dose 20 mg once daily ≥25 to <60 eGFR (mL/min/1.73 m2): Starting dose 10 mg once daily <25 eGFR (mL/min/1.73 m2): Not Recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally
| Condition | Dosage | Notes |
|---|---|---|
| Prior to Initiation of Kerendia | Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation | Do not initiate treatment if serum potassium is >5.0 mEq/L |
| Recommended Starting Dosage | The recommended starting dose of Kerendia is based on eGFR | ≥60 eGFR (mL/min/1.73 m2): Starting dose 20 mg once daily ≥25 to <60 eGFR (mL/min/1.73 m2): Starting dose 10 mg once daily <25 eGFR (mL/min/1.73 m2): Not Recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally |
Interaction of Firendia 10 mg
Strong CYP3A4 Inhibitors: Firendia 10 mg is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases Firendia 10 mg exposure, which may increase the risk of Firendia 10 mg adverse reactions. Concomitant use of Firendia 10 mg with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.Moderate and Weak CYP3A4 Inhibitors: Firendia 10 mg is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases Firendia 10 mg exposure, which may increase the risk of Firendia 10 mg adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Firendia 10 mg or the moderate or weak CYP3A4 inhibitor, and adjust Firendia 10 mg dosage as appropriate.Strong and Moderate CYP3A4 Inducers: Firendia 10 mg is a CYP3A4 substrate. Concomitant use of Firendia 10 mg with a strong or moderate CYP3A4 inducer decreases Firendia 10 mg exposure, which may reduce the efficacy of Firendia 10 mg. Avoid concomitant use of Firendia 10 mg with strong or moderate CYP3A4 inducers.
Contraindications
Firendia 10 mg is contraindicated in patients: Who are receiving concomitant treatment with strong CYP3A4 inhibitors, With adrenal insufficiency.
Side Effects of Firendia 10 mg
The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia.
Precautions & Warnings
Hyperkalemia: Firendia 10 mg 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 Firendia 10 mg and dose accordingly. Do not initiate Firendia 10 mg if serum potassium is >5.0 mEq/L. Measure serum potassium periodically during treatment with Firendia 10 mg 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.
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Mode Of Action
Firendia 10 mg is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription.
Absorption
Firendia 10 mg blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.
Distribution
, heart, and blood vessels) tissues.
Metabolism
MR overactivation is thought to contribute to fibrosis and inflammation.
Excretion
Firendia 10 mg has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.
Pregnancy
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 2 to 4% and 15 to 20%, respectively.There are no data on the presence of Firendia 10 mg or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production. In a pre-and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 4 times the AUC unbound expected in humans. These findings suggest that Firendia 10 mg is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Firendia 10 mg, avoid breastfeeding during treatment and for 1 day after treatment.
Pediatric Uses
Pediatric Use: The safety and efficacy of Kerendia have not been established in patients below 18 years of age.Geriatric Use: Of the 2827 patients who received Kerendia 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 Kerendia 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 additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B)
Frequently Asked Questions
What is Firendia 10 mg used for?
Finerenone is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
What is the dosage of Firendia 10 mg?
Prior to Initiation of Kerendia: Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is >5.0 mEq/L.Recommended Starting Dosage: The recommended starting dose of Kerendia is based on eGFR. ≥60 eGFR (mL/min/1.73 m2): Starting dose 20 mg once daily ≥25 to <60 eGFR (mL/min/1.73 m2): Starting dose 10 mg once dail…
What are the side effects of Firendia 10 mg?
The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia.
Who should not take Firendia 10 mg?
Finerenone is contraindicated in patients: Who are receiving concomitant treatment with strong CYP3A4 inhibitors, With adrenal insufficiency.
What precautions should be taken with Firendia 10 mg?
Hyperkalemia: 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 …
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.