lokelma mechanism of action
Lokelma was effective in lowering potassium levels in patients with chronic kidney disease, heart failure, diabetes mellitus and those taking RAAS inhibitor therapy. Medically reviewed by Drugs.com. Fertility in male and female rats has been assessed at doses up to a Human Equivalent Dose (HED) of 58 g per day (the maximum feasible dose) with no adverse effects. Pitt B, Bakris GL. Each 5 g dose of Lokelma contains approximately 400 mg of sodium, but the extent of absorption by the patient is unknown. PloS One. 1. US-39847; US-42950 Last Updated 11/20. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The clinical significance of this finding is unclear.1. Trial Data Confirm: Veltassa, Lokelma Effective for Hyperkalemia — But agents' long-term safety and efficacy not yet established. In patients not continuing Lokelma, potassium levels increased. Lokelma works directly in the intestines and is not absorbed into your bloodstream. Lokelma and Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action … Sodium zirconium cyclosilicate is a non-absorbed, non-polymer inorganic powder with a … Patiromer: Can less be better than more? Patients who achieved a potassium level between 3.5 and 5 mEq/L after receiving Lokelma during the acute phase were re-randomized to receive once daily placebo or 1.25, 2.5, 5 or 10 g of once daily Lokelma for 12 days together with breakfast. 4. The treatment effect on mean pre-dialysis serum potassium levels was maintained during continued treatment. Approximately 60% of patients had chronic kidney disease, 10% had heart failure, 62% had diabetes mellitus and 67% were on renin angiotensin aldosterone system (RAAS) inhibitor therapy at baseline. … In a clinical study in patients with hyperkalemia in which zirconium concentrations were measured in the urine and blood, zirconium concentrations were similar in treated and untreated patients (i.e., either undetectable … by Ashley Lyles, Staff Writer, MedPage Today May 10, 2019 Mayo Clin Proc. Sodium zirconium cyclosilicate (Lokelma®) is a non-absorbed potassium-binding polymer. Figure 5: Mean Pre-Dialysis Serum Potassium Levels Over Time in Patients on Chronic Hemodialysis. Lokelma is used to treat hyperkalemia (high levels of potassium in the blood) in adults. Palmer BF. Veltassa is a registered trademark of Relypsa, Inc., a Vifor Pharma Group Company. No overall differences in safety or effectiveness were observed between these patients and younger patients. Dosage Adjustment for Patients on Chronic Hemodialysis For patients on chronic hemodialysis, administer LOKELMA only on non-dialysis days. Figure 4: 11-Month Open-Label Extension Phase of Study 2 - Mean Serum Potassium (mEq/L). During initiation and after a dose adjustment, assess serum potassium after one week. Monitor serum potassium and adjust the dose of Lokelma based on the pre-dialysis serum potassium value after the long inter-dialytic interval and desired target range. In a clinical study in patients with hyperkalemia in which zirconium concentrations were measured in the urine and blood, zirconium concentrations were similar in treated and untreated patients (i.e., either undetectable or around the lower limit of quantification of the assay). The dose reached at the end of the dose-adjustment period was maintained throughout the subsequent 4-week evaluation period. Lokelma’s mechanism of action. Meaney CJ, Beccari MV, Yang Y, Zhao J. The study met its primary endpoint demonstrating a greater reduction in serum potassium levels for the 2.5, 5 and 10 g (three times a day) dose groups compared to the placebo group (p < 0.001). Mechanism of action. Lokelma is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Lokelma and Veltassa are indicated for the treatment of hyperkalemia. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L. Core Evid. Available for Android and iOS devices. Inform the patient that it is necessary to drink the full dose [see Dosage and Administration (2.3)]. In clinical trials of Lokelma in patients who were not on dialysis, edema was observed and was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily. Given that zirconium cyclosilicate is not genotoxic, not absorbed from the gastrointestinal tract, and did not cause local gastrointestinal alterations in a chronic toxicity study in dogs, carcinogenicity studies in animals to evaluate tumorigenic potential of sodium zirconium cyclosilicate were not deemed to be necessary.