following a resubmission: sodium zirconium cyclosilicate (Lokelma) is accepted for restricted use within NHSScotland.. IMPORTANT SAFETY INFORMATION FOR LOKELMA (sodium zirconium cyclosilicate) What is the most important thing I should know about LOKELMA? JAMA. Add Resources to Your List. sodium zirconium cyclosilicate will increase the level or effect of tolbutamide by increasing gastric pH. cationic exchange resins We investigated whether sodium zirconium cyclosilicate (ZS-9), a novel selective cation exchanger, could lower serum potassium levels in patients with hyperkalemia. Sodium Zirconium Cyclosilicate - Last updated on October 15, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. It got FDA approval in 2018. Class. Hyperkalemia is more common in people with kidney disease, heart failure, high blood pressure and diabetes. It has been studied in three double-blind . Lokelma (sodium zirconium cyclosilicate) is a prescription drug that treats hyperkalemia in adults. 22 Sodium zirconium cyclosilicate is mainly excreted in the faeces and not systemically . Log in to print or send this list to your patient and save lists of resources you use frequently. Sodium zirconium cyclosilicate comes as a powder in a packet to mix with water and take by mouth with or without food. It has a mean particle size of 20 m and includes no more than 3% of particles with a diameter below 3 m. Sodium Zirconium Cyclosilicate (SZC) is an oral potassium binder, essentially an upgrade of sodium polystyrene sulfonate (Kayexalate). Read all information given to you. Sodium zirconium cyclosilicate causes transient increases in gastric pH and can affect solubility (and consequent bioavailability) of certain pH-dependent drugs. Kosiborod, M, Rasmussen, HS, Lavin, P. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial [published correction appears in JAMA. It should not be used as an emergency treatment for life-threatening hyperkalemia. Sign Up Sodium zirconium cyclosilicate is an insoluble, non-absorbed, non-polymer inorganic material designed to bind potassium ions with proven selectivity to treat hyperkalaemia. Each 5 g of sodium . Sodium zirconium cyclosilicate among individuals with hyperkalemia: a 12-month phase 3 study. Sodium zirconium cyclosilicate is a nonabsorbed cation exchanger that selectively binds potassium in the intestine.Objective To evaluate the efficacy and safety of zirconium cyclosilicate for 28 . Lokelma is available in 5g and 10g packets. It preferentially binds to potassium even in the presence of other cations such as calcium and magnesium ions. Sodium zirconium cyclosilicate is a potassium binder with a high affinity for potassium ions. It is a non-absorbable inorganic compound that exchanges sodium and hydrogen ions for potassium. This product is available in the following dosage forms: LOKELMA can cause swelling (edema) caused by fluid retention in your body (such as hands, ankles, feet). [2] When dietary counseling and dietary restriction are not effective, and MHD patients continue to develop hyperkalemia, these newer medications can be used. Sodium zirconium cyclosilicate is not used for emergency treatment of life-threatening hyperkalemia because it takes some time to work. In January 2022, changes were made to recommendations 1.1 and 1.2 because sodium zirconium cyclosilicate is now available in both primary and secondary care. Heath, M.; Mann, C., 2022: Sodium zirconium cyclosilicate to increase lithium elimination AZ acquired Lokelma ( sodium zirconium cyclosilicate) via a $2.7bn acquisition of ZS Pharma three years ago, but suffered serious setbacks in its approval thanks . Efficacy and safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an 11-month open-label extension of HARMONIZE. Class. However, the effects of SZC during the perioperative period remained unknown. The applicant, ZS Phanna Inc., has sought marketing approval for sodium zirconium cyclosilicate for oral suspension under the provisions of Section 505(b)(l). LOKELMA is a free flowing, odorless, insoluble white powder for oral suspension. Sodium zirconium cyclosilicate works directly in the intestines and is not. 2019;14(6):798-809. Sodium zirconium cyclosilicate contained in Lokelma is an insoluble, non-absorbable inorganic crystalline compound that works as a potassium blinder. When starting treatment with sodium zirconium cyclosilicate, it should be taken three times a day for up to 48 hours. About Lokelma (sodium zirconium cyclosilicate [SZC]) SZC is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing agent. Sodium zirconium cyclosilicate powder for oral suspension is a non-absorbed, insoluble, free-flowing, odorless, tasteless white crystalline powder. This page shows the latest sodium zirconium cyclosilicate news and features for those working in and with pharma, biotech and healthcare. This medicinal product contains approximately 400 mg sodium per 5 g dose, equivalent to 20% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicine is a potassium binder. Methods: In this multicenter, two-stage, double-blind, phase 3 trial, we randomly assigned 753 patients with hyperkalemia to receive either ZS-9 (at a dose of 1.25 g, 2.5 g, 5 g, or . {{configCtrl2.info.metaDescription}} Sign up today to receive the latest news and updates from UpToDate. HARMONIZE-Global examined the efficacy and safety of SZC among outpatients with hyperkalaemia from diverse geographic and ethnic origins. 4 An in vivo mass balance study in rats showed that sodium zirconium cyclosilicate was recovered in the feces with no evidence of systemic absorption. Corrective treatment of hyperkalemia in adult patients (10 g administered three times per day, for 48 hours but up to 72 hours as needed), in line with the anticipated Health Canada approved indication. When starting treatment with sodium zirconium cyclosilicate, it should be taken three times a day for up to 48 hours. Hyperkalemia is a common clinical problem that is most often a result of impaired urinary potassium excretion due to acute or chronic kidney disease (CKD) and/or disorders or drugs that inhibit the renin-angiotensin-aldosterone system (RAAS). Trade Name (s) Lokelma Ther. Are not taking, or are taking a reduced dosage of, a renin- [8] It is administered orally, is odourless, tasteless, and stable at room temperature. Patients with persistent hyperkalaemia with a confirmed serum potassium level of at least 6.0 mmol/L, and 2. hypokalemic electrolyte modifiers Pharm. It exchanges hydrogen and sodium ions for Potassium. Sodium zirconium cyclosilicate (Lokelma) is a drug that binds potassium. Lokelma (sodium zirconium cyclosilicate) is a treatment option for hyperkalemia (high potassium levels in the body) in nonemergency situations. 1 5. Lokelma is considered high in sodium. Sodium zirconium cyclosilicate is used to treat hyperkalemia (high potassium in the blood). sodium zirconium cyclosilicate General Pronunciation: soe -dee-um zir- koe -nee-um sye -kloe- sil -i-kate To hear audio pronunciation of this topic, purchase a subscription or log in. Sodium zirconium cyclosilicate Lokelma 5 g, powder (Astra Zeneca) After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water. Each 5-g dose of sodium zirconium cyclosilicate contains approximately 400 mg of sodium; in clinical trials, mild-to-moderate edema was more commonly seen in patients treated with 15 g once daily; monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (e.g., heart failure . This copyrighted material has been downloaded from a licensed data provider. Sodium zirconium cyclosilicate (SZC, formerly ZS-9) is a selective K + binder to treat adults with hyperkalaemia. Swelling of the ankles or feet . Indication under review: treatment of hyperkalaemia in adult patients.. SMC restriction: patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease (CKD) stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or . [2] Common side effects include swelling and low blood potassium. Lokelma is highly effective and has a very rapid onset of action compared to all the . Affiliations. DRUG: Sodium Zirconium Cyclosilicate (SZC) Introduction: Indication: Hyperkalaemia in patients with heart failure or stage 3b to 5 chronic renal failure if they have: 1. Sodium zirconium cyclosilicate comes as a powder in a packet to mix with water and take by mouth with or without food. Stir well and drink right away. Sodium zirconium cyclosilicate is in a class of medications called potassium removing agents. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. It is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium, even in the presence of other cations such as calcium or magnesium. If simultaneous administration is required, monitor for signs and symptoms of warfarin toxicity (eg, elevated INR, bleeding). tolbutamide. Sodium zirconium cyclosilicate (ZS-9) is a highly selective cation exchanger that entraps potassium in the intestinal tract in exchange . Information last revised October 2021. LOKELMA is a free flowing, odorless, insoluble white powder for oral suspension. Duration: 12 weeks. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. s1 in the supplementary. Management: Separate the administration of sodium zirconium cyclosilicate and warfarin by at least 2 hours. [2] It is taken by mouth. 1 This is a potentially serious condition caused by raised potassium levels in the blood and is frequently associated with chronic kidney disease, heart failure and diabetes. Follow all instructions closely. Clinical trials indicate that it is stable at room temperature. Sodium zirconium cyclosilicate and patiromer are effective cation exchangers that exchange such cations as sodium and calcium for potassium in the gastrointestinal tract. Lokelma (sodium zirconium cyclosilicate) is a highly-selective, oral potassium-removing agent. 4, 5 The phase IIIb DIALIZE study ( NCT03303521) revealed that SZC is an effective and well-tolerated treatment for . In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. 16. Sodium zirconium cyclosilicate is used to treat hyperkalemia (high levels of potassium in the blood) in adults. szc, formerly known as zs-9, is an insoluble, inorganic, nonpolymer zirconium silicate compound comprising units of oxygen-linked zirconium and silicon atoms in the form of a microporous cubic lattice framework.5 it works as a selective cation exchange agent, primarily releasing hydrogen and sodium and preferentially capturing potassium, Sodium zirconium cyclosilicate (ZS-9) is a highly selective cation exchanger that entraps potassium in the intestinal tract in exchange for sodium and hydrogen (Fig. Learn about side effects, dosage, and more. After that, it is usually taken once a day or once every other day. 4 ZS-9 (sodium zirconium cyclosilicate) is an insoluble, non-absorbed zirconium silicate compound in clinical development and acts as a highly selective potassium-removing agent. SZC is an orally administered, insoluble, nonabsorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for hydrogen and sodium ions in the gastrointestinal lumen. Methods and results. 2015;313 (5):526]. 4 Additionally, studies have shown it not to be systemically absorbed either. Take sodium zirconium cyclosilicate at . Administer sodium zirconium cyclosilicate 2 hours before or 2 hours after other oral drugs unless it is determined that the other drug does not exhibit pH-dependent solubility. 1 Department of Emergency Medicine, MSC 8072-17-5001, Washington University School of Medicine, 660 S. Euclid Avenue, Saint Louis, MO 63110-1010, United States of America. Thus, there is a need for additional agents that can safely treat hyperkalemia in both patients with acute disease and those with chronic disease. Clin J Am Soc Nephrol. 2014 ;312 (21): 2223 - 2233. Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder that is not absorbed or metabolized by the body [ 17 ]. Find patient medical information for sodium zirconium cyclosilicate oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The free concentration of serum potassium is reduced and fecal excretion of potassium is increased, resolving hyperkalemia. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. It has a mean particle size of 20 m and includes no more Evidence-based recommendations on sodium zirconium cyclosilicate (Lokelma) for treating hyperkalaemia in adults. What are side effects of Lokelma Common side effects of Lokelma include: mild to moderate swelling DESCRIPTION LOKELMA is a powder for oral suspension. Non-absorbed zirconium silicate that captures potassium in exchange fro hydrogen and sodium Increases fecal potassium excretion through binding K+ in GI tract Comments Onset of action at 1.0 hour and median time to achieving normal potassium levels at 2.2 hours, with 92% achieving normal potassium within 48 hours. It is a newly approved potassium binding resin marketed by AstraZeneca. Sodium Zirconium Cyclosilicate is a non-absorbable drug that acts by inhibiting potassium absorption from the gut. Maintenance treatment of hyperkalemia in adult CKD patients with an eGFR of 30 ml/min/1.73m2, that have had at least 2 HK events and are sub . How does sodium zirconium Cyclosilicate corrects hyperkalemia? Briefly, this agent is an inorganic cation exchange crystalline compound that allows a thermodynamically favourable catching of potassium ions. If the patient is having abdominal X-rays, radiographers should keep this in mind. Potassium binders are used to treat a condition called hyperkalemia, which is when you have too much potassium in your blood. [2] Use is likely safe in pregnancy and breastfeeding. The zirconium cyclosilicate portion of Lokelma isn't absorbed through the gut and into the bloodstream. Lokelma is specifically indicated for the treatment of hyperkalemia in adults. Sodium zirconium cyclosilicate may be opaque to X-rays. 2 Department of Emergency Medicine, MSC 8072-17-5001, Washington University School of Medicine, 660 S. Euclid Avenue . Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder that preferentially captures potassium in the gastrointestinal lumen, increasing potassium fecal excretion and thereby reducing sK + concentration. SZC is studied predominantly for subacute to chronic reduction in potassium. The recommended dose is 10 g administered three times a day for up to 48 hours. Sodium zirconium cyclosilicate is used to treat hyperkalemia (high levels of potassium in the blood). Sodium Zirconium Cyclosilicate. LOKELMA contains 400 mg of sodium in each 5 g dose. Decreased potassium level in the blood. S1 in the Supplemen - Lokelma is supplied as a solution for oral administration. Sodium zirconium cyclosilicate RICaD Date:- July 2022 Review date: July 2025 Based on HeFT RICaD template Prepared by Satnaam Singh Nandra Interface Lead Pharmacist Birmingham CrossCity CCG Suggested Criteria for Continuation or Discontinuation Assessment of Efficacy Frequency At least 1 week after initiation and any dose changes. Instead, this part of Lokelma stays in your gut and trades its sodium and hydrogen for potassium. [2] Onset of effects occurs in one to six hours. sodium zirconium cyclosilicate 10 gram oral powder packet. It attaches to potassium in the patient's food and body fluids in the lumen of the gastrointestinal tract and lowers the serum potassium levels. After that, it is usually taken once a day or once every other day. Therapy for hyperkalemia due to potassium retention is ultimately aimed at inducing potassium loss [ 1-3 ]. Lokelma is the brand name of Sodium Zirconium Cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations. Unlike sodium polystyrene sulfonate, SZC doesn't appear to cause bowel necrosis. Educational Resources. The above information is intended to supplement . Mix the contents of the packet in a glass with about 3 tablespoons (45 mL) or more of water. Electronic address: a.burtle@wustl.edu. sodium zirconium cyclosilicate (zs-9) is a highly selective cation exchanger that entraps potassium in the intestinal tract in exchange for sodium and hydrogen (fig. Sodium zirconium cyclosilicate ( ZS-9 ), sold under the brand name Lokelma, is a medication used to treat high blood potassium. Roger SD, Spinowitz BS, Lerma EV, et al. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Warfarin: Sodium Zirconium Cyclosilicate may increase the serum concentration of Warfarin. This medicine is available only with your doctor's prescription. Sodium zirconium cyclosilicate (Lokelma) [hereafter referred to as SZC] is a non-absorbed, non-polymer zirconium silicate compound that preferentially exchanges hydrogen and sodium for potassium and ammonium ions in the gastrointestinal tract (GIT), thereby increasing faecal potassium excretion and lowering serum potassium levels. Sodium zirconium cyclosilicate is an inorganic, insoluble compound that is not susceptible to enzymatic metabolism. It is administered orally and is odourless and tasteless. Lokelma (sodium zirconium cyclosilicate) is used to treat high blood potassium ( hyperkalemia) in adults. Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. Sodium Zirconium Cyclosilicate Authors: Terri L Levien Washington State University Danial E. Baker Washington State University Abstract and Figures Each month, subscribers to The Formulary. If there is powder in the glass after taking your dose, add more water, stir, and drink right away. Do this until there is no more powder. 23 It acts within 1 h of administration by permanently removing excess potassium in the gastrointestinal tract. The most common side effects of sodium zirconium cyclosilicate are-. SZC preferentially captures potassium in the gastrointestinal lumen, thereby reducing potassium absorption and increasing potassium fecal excretion, and reducing sK + [ 17 - 19 ]. Edema or fluid accumulation in the body. To 48 hours ( eg, elevated INR, bleeding ) more water, stir and. 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