United States Securities and Exchange Comission; Form 8-K, Relypsa, Inc. http://investor.relypsa.com/secfiling.cfm?filingid=1193125-15-350034&cik=1416792 . The starting dose is 8.4 g daily, which is increased weekly based on potassium levels to … Relypsa, Inc.; 2016. may see it sometimes referred to as ZS-9 when it was first being studied in the Of the 751 patients, 746 (99%) achieved normokalemia during the first 72 hours. 3/16/2021Call for Evaluators: Student Platform Continuing Education Presentation Night - Spring 2021, 3/10/20212021 Anthony Sorrentino Student Award Nominations, 3/19/2021Advancing Amb Care Pharmacy in PA: All invited to PSHP open forums: March, 3/25/2021Webinar: Handling Hazardous Drugs in the Pharmacy Setting: Mitigating Risks Outside the Chemo Hood, 4/14/2021Advancing Amb Care Pharmacy in PA: All invited to PSHP open forums: April, 4/20/2021Student Platform Continuing Education Presentation Night - Spring 2021, Membership Management Software Powered by, Relypsa, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its very first medication, Veltassa. In Phase I, all study participants received patiromer at a starting dose of either 8.4g or 16.8g daily, in two divided doses, for 4 weeks.8 Results registered a mean decrease in serum potassium concentration of 1.01 mEq/L, and 76% of patients had serum potassium levels within the target range (3.8-5.1 mEq/L) at the end of 4 weeks. The other most common side effect was GI upset including mild diarrhea, nausea, and abdominal cramping. Patiromer sorbitex calcium (Veltassa) is a nonabsorbed, cation exchange polymer that contains a calcium-sorbitol counterion. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. U.S. Food and Drug Administration; Safety; Kayexalate (sodium polystyrene sulfonate) powder. SPS (Kayexalate). over its generic name, Zirconium cyclosilicate, since it says right in the name Their paper titled, “Single-dose sodium polystyrene sulfonate for hyperkalemia in chronic kidney disease or end-stage renal disease” from 2019 (Link) used retrospective data of 114 CKD/ESRD patients with hyperkalemia. What is Veltassa? completely insoluble in aqueous solutions, and therefore, there is no systemic Pitt B, Anker SD, Bushinsky DA, et al. The experimental arm will receive Lokelma 10 mg tid in addition to insulin/dextrose, while the control arm will receive placebo in addition to insulin/dextrose. The drug, Veltassa, is designed to treat hyperkalemia, a chronic condition characterized by excessive potassium levels in the blood that could lead to dangerous changes in heart rhythm. Winkelmayer WC. N Engl J Med. As mentioned in Mr. Jensen's article, ZS-9 is expected to debut on the market later this year. Updated February 17, 2011. Effect of Patiromer on Serum Potassium Level in Patients With Hyperkalemia and Diabetic Kidney Disease: The AMETHYST-DN Randomized Clinical Trial. Once they achieved normokalemia, they were randomized to receive Lokelma 5-g qd for 12 months without any dietary or medication restrictions. ZS-9 was found to bind lithium, which is a highly relevant fact. existed): “Zirconium is a biologically inert trace element found widely in Published October 21, 2015. Other medications like clopidogrel, furosemide, metformin, metoprolol, and warfarin were bound 30-50% to Veltassa. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. It also addresses some other retrospective studies on Kayexalate as well as the only RCT of Kayexalate I can find (linked here “Randomized Clinical Trial of Sodium Polystyrene Sulfonate for the Treatment of Mild Hyperkalemia in CKD 2015), which showed a mean reduction of 1.25 mEq/L at 7 days compared to placebo with reduction 0.21 mEq/L at 7 days (sample size of total 33 patients). In Phase I, all study participants received patiromer at a starting dose of either 8.4g or 16.8g daily, in two divided doses, for 4 weeks. Phase II of the OPAL-HK study was an 8-week, randomized withdrawal phase, aimed at examining the effects of continuation of patiromer versus administration of placebo. 2015. 3 Inconsistencies across the literature exist with regard to characterization of hyperkalemia; a serum or plasma potassium level greater than the upper limit of normal (∼5.0–5.5 mEq/L) is generally regarded as abnormal. Accessed January 7, 2016. (e.g. Center for Drug Evaluation and Research; Application Number 205739Orig1s000. Lokelma (loh-KEL-mah, sodium zirconium cyclosilicate) will be a new option to treat high potassium levels, or hyperkalemia. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000ODMemo.pdf . The recommended starting dose of Veltassa is 8.4 grams once daily. $595.0013 ($19.83/day) $1,785.00 ($59.50/day) KayexalateTM. The frequency of hyperkalemia and its significance in chronic kidney disease. 8. Already, physicians report prior authorization challenges and requirements to demonstrate prior failed use with generically available sodium polystyrene sulfonate (Concordia’s Kayexalate). 2011;32(7):820-8. Effect of Patiromer on Serum Potassium Level in Patients With Hyperkalemia and Diabetic Kidney Disease: The AMETHYST-DN Randomized Clinical Trial. Treatment of hyperkalemia: From "Hyper K+" strikeout to home run?. Approximately 9% of patients in clinical trials developed hypomagnesemia with a serum magnesium value 1.4 mg/dL. As with all new drugs, acceptance by the medical community remains to be seen. Based upon the 2-3% incidence of hyperkalemia in the general population4, 6.4-9.6 million people in the United States alone may qualify for treatment with patiromer. This study also showed that Lokelma was relatively well tolerated. 7. FDA approval. It should be noted that patiromer also binds magnesium. 2015;314(2):151-61. renin-angiotensin-aldosterone system inhibitors. It increases … The placebo group had a mean reduction 0.3 mEq/L. heart failure patients with an indication to initiate spironolactone and serum potassium concentration of between 4.3 and 5.1 mEq/L. The lowest GoodRx price for the most common version of generic Kayexalate is around $14.30, 58% off the average retail price of $34.84. How LOKELMA works. In addition, ~92% of patients showed normal potassium levels within 48 hours. There is currently only one contraindication to patiromer; sensitivity to patiromer or any component of the drug formulation. Accessed December 21, 2015. Oxana Placinta, PharmD Candidate 2018 [package insert]. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Office Director Memo. This paper is definitely worth a read! 4. Call for Evaluators: Student Platform Continuing Education Presentation Night - Spring 2021, 2021 Anthony Sorrentino Student Award Nominations, Advancing Amb Care Pharmacy in PA: All invited to PSHP open forums: March, Webinar: Handling Hazardous Drugs in the Pharmacy Setting: Mitigating Risks Outside the Chemo Hood, Advancing Amb Care Pharmacy in PA: All invited to PSHP open forums: April, Student Platform Continuing Education Presentation Night - Spring 2021. Updated February 17, 2011. Furthermore, Lokelma differs from our friend, Kayexalate, This is a good design since we can say that the decrease in K is likely largely from the use of single-dose Kayexalate. The Lokelma 10-g group showed a mean reduction of 0.7 mEq/L vs. a 0.5 mEq/L reduction in both the 5-g and 2.5-g groups. Patiromer is not indicated for emergency correction of life-threatening hyperkalemia. 2015; 314(22); 2405. 751 patients with CKD received Lokelma 10 g tid for 24-72 hours. which is why it can result in hypocalcemia and hypomagnesemia. Tamargo J, Caballero R, Delpón E. New drugs for the treatment of hyperkalemia in patients treated with renin-angiotensin-aldosterone system inhibitors -- hype or hope?. Maybe one day we’ll even see a randomized, controlled, head-to-head trial of all these medications…, Rush University Medical Center The improved side effect profile over current therapy and the potentially manageable price difference make patiromer an exciting avenue to be further explored. The study found a decreased serum potassium of 0.22 mEq/L versus an increase of 0.23 mEq/L with placebo. According to Vifor Pharma’s recent report, 53% of prescriptions require prior authorization for Veltassa. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. Kayexalate works by helping your body get rid of extra potassium. 9. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa. Several clinical trials have documented the safety and efficacy of patiromer in at-risk patient populations. On the Horizon… Study evaluating Lokelma in patients with acutely elevated K>5.8. 6. Redwood,CA. They all bring down potassium levels by binding potassium in the gut...and removing it from the body. What’s the evidence behind it? United States Securities and Exchange Comission; Form 8-K, Relypsa, Inc. http://investor.relypsa.com/secfiling.cfm?filingid=1193125-15-350034&cik=1416792. Watch the video to find out more about LOKELMA's mechanism of action. Hyperkalemia is defined as potassium levels above 5.5 mEq/L, and can occur as a result of increased potassium intake, decreased renal excretion, or imbalanced distribution of potassium between the intracellular and extracellular space. For instance, it has been known that ARB/ACE-I are renal protective and would be the ideal HTN medication in patients with CKD. 258 patients with CKD and hyperkalemia received Lokelma 10 grams tid in 48-hour period. Randomized 753 patients with CKD and hyperkalemia to Lokelma 2.5 g, 5 g, 10 g tid, or placebo for 48 hours. Again, this study showed improved rate of normokalemia in the Lokelma group vs. placebo in days 3-14. One important caveat of these trials is that Lokelma was studied in patients with CKD with mild hyperkalemia, “Randomized Clinical Trial of Sodium Polystyrene Sulfonate for the Treatment of Mild Hyperkalemia in CKD 2015. Am J Med … In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3% of patients treated with VELTASSA. This study is right in the ED realm! Again, this study excluded patients with K>6.5, EKG changes, patients requiring hospitalization, and patients receiving HD. Patients had CKD or were receiving one or more heart failure therapies (ACEI/ARB/Beta Blocker). Veltassa works similarly to Kayexalate and Lokelma in that it absorbs potassium in the GI tract. used to treat hyperkalemia in patients with renal insufficiency). Lastly, Lokelma is also a relatively safe agent as it is Winkelmayer WC. Kayexalate (sodium polystyrene) is a cation-exchange resin used to treat high levels of potassium in the blood, also called hyperkalemia. The likelihood of mortality within 1 day of moderate (K ≥ 5.5 and < 6.0 mEq/L) and severe (≥ 6.0 mEq/L) hyperkalemic events is significant, with odds ratios of 10.3 and 31.6 (p < .001), respectively, in patients with normal kidney function.5 Considering the potential for negative outcomes, outpatient treatment of hyperkalemia (both acute and chronic) is essential, but is limited by the lack of safe and efficacious agents. Based on trial evidence to date, patiromer appears to be a viable option for the management of hyperkalemia, especially in patients with CKD, diabetes, and heart failure who may experience hyperkalemia chronically. Think of Lokelma as similar to sodium polystyrene sulfonate (Kayexalate, etc) or Veltassa (patiromer). 12. Maintaining potassium levels within the normal range is extremely important. Sodium polystyrene is an agent commonly considered for the treatment of hyperkalemia, however, long-term use of this agent has been associated with rare but potentially severe side effects such as colonic (intestinal) necrosis, bleeding, and bowel perforation.6 These side effects are more commonly seen in patients with abnormal bowel function, or those at risk for constipation or impaction. In contrast, Kayexalate is a nonspecific binding agent The median starting potassium level was 5.7 mEq/L. Lokelma and Veltassa could decrease the absorption of other medications and reduce their effectiveness. Most adverse reactions were mild to moderate. Published October 21, 2015. Prescription Settings. 2016;85(1):38-43. 2014; 18(100):249-54. Preliminary results have been released but no formal study results have been compiled. Einhorn LM, Zhan M, Hsu VD, et al. Veltassa (patiromer) is a medicine that binds itself to potassium in your digestive tract. Clinical Journal of American Society of Nephrology 2019 (Link). It is important to bear in mind that completed trials have not evaluated the use of patiromer beyond 12 weeks. One issue with this medication is that it also binds magnesium and can result in hypomagnesemia (5.3% of patients), which is not seen with Lokelma. 10. The main advantage of patiromer over sodium polystyrene is the reported reduced side effect profile. It is important to bear in mind that completed trials have not evaluated the use of patiromer beyond 12 weeks. Dept. Center for Drug Evaluation and Research; Application Number 205739Orig1s000. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186845.htm. Palmer B, Clegg D. Hyperkalemia. has been implicated as a cause of intestinal necrosis and is not recommended. Of these studied patients, 63% of patients completed the 12-month time period. Generic Name: patiromer. One issue with this medication is that it also binds magnesium and can result in hypomagnesemia (5.3% of patients), which is not seen with Lokelma. 2014; 18(100):249-54. Answer. recovery of Lokelma in stool of rats treated with Lokelma. 2015;314(2):151-61. Phone: (312) 942-7802 It should be noted that patiromer also binds magnesium. 2015;372(3):211-21. The potassium lowering effects of Lokelma were further evidenced by the maintenance phase that showed a stepwise decline in K levels depending on Lokelma dose. Bakris GL, Pitt B, Weir MR, et al. what it does—it lowers your potassium. Sanofi-Aventis U.S. LLC; 2009. Arch Intern Med. Accessed January 7, 2015. There are 4 published studies on the use of Lokelma for treating hyperkalemia in patients with mild hyperkalemia in CKD. After achieving normokalemia, these patients were then randomized to receive Lokelma 5g, 10g, or placebo for 14 days. JAMA. There is currently a phase 2, multicenter, randomized, double-blind, placebo study underway called “A Study to Evaluate a Potassium Normalization Treatment Regiment Including Sodium Zirconium Cyclosilicate (ZS) among Patients with S-K >5.8 (ENERGIZE)” (Link). VELTASSA is not absorbed by the body. Due to the incidence of constipation as a side effect, patiromer should be avoided in patients that have severe constipation, history of obstructed or impacted bowels, and bowel motility disorders. Several clinical trials have documented the safety and efficacy of patiromer in at-risk patient populations. The most common adverse effects reported by patients taking patiromer were constipation (7.2%), hypomagnesaemia (5.3%) and diarrhea (4.8%). It is designed to investigate the use of Lokelma in patients with acute hyperkalemia with K>5.8. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186845.htm. Our faculty are internationally recognized for their teaching accomplishments, scholarship, and dedication to excellent patient care. Hyperkalemia is a common and important electrolyte disorder that results from impaired renal potassium excretion, abnormality in the cellular distribution of potassium, excessive dietary intake in the setting of abnormal renal function, or often, a combination of these factors. It’s shown it can lower potassium and seems fairly well tolerated by patients even in longterm use. KAYEXALATE can be administered either orally or as an enema. Kayexalate hasn’t gotten a lot of love as of late. Patients were stratified by baseline serum potassium level, and received 1 of 3 randomized starting doses ranging from 4.2g twice daily to 16.8g twice daily. Most currently available treatments for hyperkalemia are indicated for acute treatment, and either shift potassium into the intracellular space (beta receptor agonists, insulin/glucagon, and sodium bicarbonate), or remove potassium from the body (loop diuretics and dialysis). One important caveat of these trials is that Lokelma was studied in patients with CKD with mild hyperkalemia. The 10-g group saw K levels decrease on average 0.92 mEq/L after 38 hours of treatment. VeltassaTM. Pitt B, Anker SD, Bushinsky DA, et al. sorbent column in early dialysis machines for its ability to bind urea. Sanofi-Aventis U.S. LLC; 2009. Below are descriptions of the 4 studies including links to the primary source. (RAASIs), beta blockers, calcineurin inhibitors, potassium sparing diuretics, and potassium supplements. I’m sure everyone has seen our new friend, Lokelma, on the Rush hyperkalemia order set. sodium polystyrene sulfonate. 13. However, just recently, we do have some evidence on the efficacy of Kayexalate… and it’s actually in conjunction with some of our own Rush ED pharmacy (shout out to Josh DeMott and Gary Peska). Veltassa’s label states that patients should not take other oral medications within 6 hours of taking Veltassa. OPAL-HK, a multi-national, single-blind, two-phase study, demonstrated the effectiveness of patiromer in CKD patients who were receiving RAASIs. Thought it would be fun to do a blog post to discuss our new medication. AMETHYST-DN, a 4-week, Phase II, multi-center, open-label, randomized clinical trial evaluated the efficacy and safety of patiromer in the treatment of patients with diabetes and CKD, +/- hypertension. Clin Nephrol. OPAL-HK, a multi-national, single-blind, two-phase study, demonstrated the effectiveness of patiromer in CKD patients who were receiving RAASIs. Monitor serum potassium and Patiromer binds potassium primarily in the distal colon where the concentration of free potassium tends to be highest, increasing fecal potassium excretion and subsequently lowering serum potassium levels. On average, onset of action was around 1 hour and median time to achieving normal potassium was 2.2 hours. 2015; 314(22); 2405. It is the first drug to be approved for this indication since the cation-exchange resin sodium polystyrene sulfonate ( Kayexalate, and others) in 1958. Administer other oral medications at least 3 hours before or 3 hours after Veltassa and 2 hours before or 2 hours after Lokelma (1-2). traps monovalent cations specifically K+ and NH4+ over divalent cations The study found a decreased serum potassium of 0.22 mEq/L versus an increase of 0.23 mEq/L with placebo.10 While the patients in this study all had baseline serum potassium concentrations less than 5.1 mEq/L, patiromer was able to prevent increases in potassium levels with concurrent use of spironolactone, a potassium sparing diuretic commonly used in heart failure regimens. The European Union's regulatory agency also approved Lokelma for use in the EU. It seems prior to 2015 when the other resin medications weren’t yet available, there was little interest in further studying Kayexalate as there were no other options. Since 2015, however, there have been multiple studies on Kayexelate as well as these new trials on Lokelma and Veltassa. The PEARL-HF clinical trial was a double-blind, randomized, placebo-controlled, parallel-group trial evaluating the efficacy and safety of patiromer over 4 weeks in chronic heart failure patients with an indication to initiate spironolactone and serum potassium concentration of between 4.3 and 5.1 mEq/L. LOKELMA is a modern K + binder that preferentially captures K + and exchanges it for hydrogen and sodium. There’s a lot of blog posts and podcasts (can take a look on EMCrit 2011 and RebelEM 2015) on their view of low evidence and potential GI side effects of using Kayexalate. AMETHYST-DN, a 4-week, Phase II, multi-center, open-label, randomized clinical trial evaluated the efficacy and safety of patiromer in the treatment of patients with diabetes and CKD, +/- hypertension. ZS-9, Veltassa and kayexalate are in the "binding agents" class of drugs. The likelihood of mortality within 1 day of moderate (K ≥ 5.5 and < 6.0 mEq/L) and severe (≥ 6.0 mEq/L) hyperkalemic events is significant, with odds ratios of 10.3 and 31.6 (, Considering the potential for negative outcomes, outpatient treatment of hyperkalemia (both acute and chronic) is essential, but is limited by the lack of safe and efficacious agents. Most currently available treatments for hyperkalemia are indicated for acute treatment, and either shift potassium into the intracellular space (beta, receptor agonists, insulin/glucagon, and sodium bicarbonate). Weir MR, Bakris GL, Bushinsky DA, et al. 2015;372(3):211-21. Patiromer binds potassium primarily in the distal colon where the concentration of free potassium tends to be highest, increasing fecal potassium excretion and subsequently lowering serum potassium levels.1The most common treatment for chronic hyperkalemia, KayexalateTM (sodium polystyrene sulfonate), was initially approved by the FDA in 1958,2 over 50 years ago, making patiromer a very innovative and exciting new option. Discov Med. Does it work? In fact, median time to normokalemia was 2.2 hours with 84% achieving normokalemia by 24 hours and 98% by 48 hours. 2. early 2010s. It also comes as the brand-name drugs Kalexate, SPS, Kionex, and Kayexalate. The average potassium level at start of study was 5.6 mEq/L with decline to 4.5 mEq/L during the first 48-hour phase. Also have quick blurbs about our friend, Kayexalate, as well as a small summary on Veltassa (Patiromer) that you may see used at other institutions. Lokelma seems like it has a lot of promise. groups for some time, and was actually used as the primary component of the It can also bind certain medications, and therefore, it is recommended that you do not take Veltassa 3 hours before or after taking other oral medications, which seems impossible in the patient population I would want to give this to. The FDA has approved patiromer ( Veltassa – Relypsa), an oral potassium binder, for treatment of hyperkalemia. Medically reviewed by Drugs.com. sodium polystyrene sulfonate ( generic) ml of oral suspension. 2 LOKELMA is insoluble and does not expand in water, so it is not expected to swell within the GI tract. Treatment of hyperkalemia: From "Hyper K+" strikeout to home run?. This helps prevent your body from absorbing too much potassium. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000ODMemo.pdf. Indeed, in Q3 2019, Veltassa actually achieved a new all-time high in both user base (95%) and number of patients treated, indicating little (if any) cannibalization at this point. 2015;314(2):129-30. How does treatment with Kayexalate compare with treatment with Veltassa? It is available as a powder that is mixed with water prior to administration. In fact, 1,2 LOKELMA has a unique crystal lattice structure. Veltassa was FDA approved in 2015 before Lokelma (2018) and may see at certain institutions. Accessed January 7, 2015. of Emergency Medicine 65% also used ARB/ACE-I with 87% of these patients able to continue or even have their dose increased while on the maintenance dose of Lokelma. 3. 2016;85(1):38-43. Arch Intern Med. Common side effects of Kayexalate include: loss of appetite, 15g/60ml. Sodium polystyrene sulfonate for the treatment of acute hyperkalemia: a retrospective study. Consumer; Professional; Note: This document contains side effect information about patiromer. making patiromer a very innovative and exciting new option. Hagan AE, Farrington CA, Wall GC, Belz MM. It was a Phase 2 trial that included 90 patients that were randomized to receive Lokelma 0.3 gram (12 pts), 3 gram (24 pts), and 10 grams (24 pts), or placebo (30 pts) tid. Office Director Memo. Accessed January 7, 2016. However, the main objective of this trial was to observe the real-life compliance of Lokelma as well as to investigate if rates of ARB/ACE-I use increased while on Lokelma.
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