Kanopas10 mg

Kanopas 10 mg 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).

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

Strong CYP3A4 Inhibitors: Kanopas 10 mg is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases Kanopas 10 mg exposure, which may increase the risk of Kanopas 10 mg adverse reactions. Concomitant use of Kanopas 10 mg with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.Moderate and Weak CYP3A4 Inhibitors: Kanopas 10 mg is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases Kanopas 10 mg exposure, which may increase the risk of Kanopas 10 mg adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Kanopas 10 mg or the moderate or weak CYP3A4 inhibitor, and adjust Kanopas 10 mg dosage as appropriate.Strong and Moderate CYP3A4 Inducers: Kanopas 10 mg is a CYP3A4 substrate. Concomitant use of Kanopas 10 mg with a strong or moderate CYP3A4 inducer decreases Kanopas 10 mg exposure, which may reduce the efficacy of Kanopas 10 mg. Avoid concomitant use of Kanopas 10 mg with strong or moderate CYP3A4 inducers.

Kanopas 10 mg is contraindicated in patients: Who are receiving concomitant treatment with strong CYP3A4 inhibitors, With adrenal insufficiency.

The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia.

Hyperkalemia: Kanopas 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 Kanopas 10 mg and dose accordingly. Do not initiate Kanopas 10 mg if serum potassium is >5.0 mEq/L. Measure serum potassium periodically during treatment with Kanopas 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.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Kanopas 10 mg is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Kanopas 10 mg 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. Kanopas 10 mg has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.

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 Kanopas 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 Kanopas 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 Kanopas 10 mg, avoid breastfeeding during treatment and for 1 day after treatment.

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)