Patiromer sorbitex calcium, which consists of patiromer, a nonabsorbed cation-exchange polymer, and a calcium-sorbitol counterion, is used for the removal of excess potassium.1, 3, 5, 7
Patiromer sorbitex calcium is used in the treatment of hyperkalemia in adults and pediatric patients 12 years of age and older.1 Because of the delayed onset of action of patiromer, the drug should not be used as an emergency treatment for life-threatening hyperkalemia.1
Efficacy of patiromer was established in a 2-part, single-blind study that consisted of a 4-week single-group, treatment phase followed by an 8-week, randomized, placebo-controlled, withdrawal phase.1, 3 Patients with stage 3 or 4 chronic kidney disease who were hyperkalemic with serum potassium concentrations of 5.1 to less than 6.5 mEq/L and who were receiving stable dosages of at least one drug that inhibits the renin-angiotensin-aldosterone system (i.e., angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor antagonist, aldosterone antagonist) were included in the study.1, 3 The mean patient age was 64 years and most patients were male (58%) and Caucasian (98%); approximately 97% of patients had hypertension, 57% had type 2 diabetes mellitus, and 42% had heart failure.1, 3
In the initial phase of the study, 243 adults (mean age 64 years, 58% men, 98% white) received patiromer.1, 3 Initial dosage of the drug was based on baseline serum potassium concentration; patients with mild or moderate-to-severe hyperkalemia (baseline serum potassium concentration of 5.1 to less than 5.5 mEq/L or 5.5 to less than 6.5 mEq/L, respectively) received an initial patiromer dosage of 8.4 or 16.8 g daily, respectively, in 2 divided doses.1, 3 Dosage was adjusted based on serum potassium concentration on day 3 and at weeks 1, 2, and 3 to achieve and maintain concentrations in the target range of 3.8 to less than 5.1 mEq/L.1, 3 The mean patiromer dosage was 13 or 21 g daily in patients with mild or moderate-to-severe hyperkalemia, respectively.1, 3 The mean reduction in serum potassium concentration from baseline to week 4 was 1.01 mEq/L; 76% of patients had serum potassium concentrations within the target range at week 4.1, 3
The randomized, placebo-controlled, withdrawal phase included 107 patients with moderate-to-severe hyperkalemia at study entry whose serum potassium concentration was in the target range at the end of the initial study phase, and who were still receiving drugs that inhibit the renin-angiotensin-aldosterone system.1, 3 Patients randomized to continue patiromer therapy received the same dosage they were receiving at the end of the initial study phase.1, 3 For those who received patiromer, the mean dosage was 21 g daily at the beginning of and during the withdrawal phase.1 The primary end point of the randomized withdrawal phase was change in serum potassium concentration from the start of the withdrawal phase to the earliest visit at which the patient's serum potassium concentration was outside the range of 3.8 to less than 5.5 mEq/L, or to week 4 of the withdrawal phase if the patient's serum potassium concentration remained in range.1, 3 Serum potassium concentration increased by a median of 0.72 mEq/L in patients who were switched to placebo but was unchanged in patients who continued receiving patiromer.1, 3 A greater proportion of patients who received placebo had a serum potassium concentration of 5.1 mEq/L or greater (91 versus 43%) or 5.5 mEq/L or greater (60 versus 15%) at any time during the withdrawal phase compared with those who received patiromer.1, 3
Efficacy of patiromer in reducing serum potassium concentration is maintained with continued use.1, 5 In a phase 2, open-label, dose-ranging study in 304 hyperkalemic patients with chronic kidney disease and type 2 diabetes mellitus who were receiving drugs that inhibit the renin-angiotensin-aldosterone system, the effect of patiromer on serum potassium concentration was maintained during continued therapy for periods of up to 52 weeks.1, 5 The mean patiromer dosage during the study was 14 g daily in patients with a baseline serum potassium concentration of greater than 5 to 5.5 mEq/L who received an initial dosage of 8.4 g daily in 2 divided doses and was 20 g daily in those with a baseline serum potassium concentration of greater than 5.5 to 6 mEq/L who received an initial dosage of 16.8 g daily in 2 divided doses.1, 5
The effects of patiromer in pediatric patients were evaluated in a single-arm, open-label study in 14 patients 12 to 17 years of age with chronic kidney disease and hyperkalemia.1 The mean age of patients was 14.5 years; 79% were male and all patients were white.1 Approximately 57% of patients were on a renin-angiotensin-aldosterone (RAAS) inhibitor at baseline.1 The study consisted of an initial 14-day dose-finding phase, followed by a long-term (up to 24 week) treatment phase and then a 2-week follow-up period.1 At baseline, the mean serum potassium was 5.5 mEq/L. Following treatment with patiromer, the mean change in serum potassium from baseline to day 14 was -0.5 mEq/L; serum potassium concentrations decreased to the normal range in 50% of the patients.1 The median dosage of patiromer at day 14 was 4.2 g daily.1
Hyperkalemia is an electrolyte abnormality associated with potentially life-threatening consequences (e.g., cardiac effects, neuromuscular symptoms, metabolic acidosis).9, 11 Hyperkalemia has been defined by an elevated serum potassium concentration of greater than 5.0 or 5.5 mEq/L, although the definition has varied and there is no consensus as to the precise potassium concentration threshold considered to be life-threatening.9, 11 Risk factors for hyperkalemia include chronic kidney disease, diabetes, heart failure, and use of RAAS inhibitors.9, 12 The management of chronic hyperkalemia differs from the acute setting and requires ongoing management to correct the underlying disturbances in potassium balance.12 Treatment options for chronic hyperkalemia have traditionally included diuretics (loop or thiazide diuretics), modification or discontinuation of RAAS inhibitors, and removal of other hyperkalemia-causing agents.9, 11, 12 Potassium binders (e.g., sodium polystyrene sulfonate, sodium zirconium cyclosilicate, patiromer) may be considered in patients with chronic hyperkalemia despite optimized diuretic therapy and correction of metabolic acidosis.9, 11, 12 Among the currently available potassium binders, the newer agents (sodium zirconium cyclosilicate and patiromer) may be better tolerated than sodium polystyrene sulfonate.9 Patiromer is not used for the emergency treatment of hyperkalemia because of its delayed onset of action,1 but it may be used to facilitate potassium lowering once emergent treatments have been initiated.11, 12
Patiromer is administered orally as an oral suspension without regard to food.1 Patiromer should be administered at least 3 hours before or 3 hours after other oral drugs, unless the drug has not been shown to have a clinically important interaction.1
Patiromer powder should be mixed with water immediately prior to administration to form an oral suspension.1 The entire contents of the packet(s) containing patiromer should be emptied into a glass or cup containing 40 mL of water.1 The mixture should be stirred and then an additional 40 mL of water should be added to the suspension.1 The suspension should again be stirred thoroughly and more water may be added to achieve the desired consistency.1 The suspension should be administered immediately after preparation.1 If powder remains in the glass after initial administration, more water should be added and the mixture should be stirred and then administered immediately; this should be repeated, as needed, until the entire dose is administered.1
The mixture can also be prepared by using other liquids or soft foods (e.g., apple sauce, yogurt, pudding) instead of water.1 A minimum volume of 45 mL (3 tablespoons) can be used to prepare doses up to and including 4 g of patiromer.1
The potassium content of liquids or soft foods used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient.1
Patiromer should not be heated (e.g., in a microwave) or added to heated foods or liquids.1
Dosage of patiromer sorbitex calcium is expressed in terms of patiromer.1
The recommended initial dosage of patiromer for the treatment of hyperkalemia is based on age.1
In pediatric patients 12 years of age or older, the recommended initial dosage of patiromer is 4 g orally once daily; dosage may be increased or decreased as necessary based on serum potassium concentrations, in 4-g increments at intervals of 1 week or longer, up to a maximum dosage of 25.2 g once daily.1
In adults, the recommended initial dosage of patiromer is 8.4 g orally once daily; dosage may be increased or decreased as necessary based on serum potassium concentrations, in 8.4-g increments at intervals of 1 week or longer, up to a maximum dosage of 25.2 g once daily.1
Dosage adjustments are not necessary in patients with renal impairment.1
Worsening of GI Motility Disorders
Patients with a history of bowel obstruction or major GI surgery, severe GI disorders, or swallowing disorders were excluded from clinical studies evaluating patiromer.1 Use of patiromer should be avoided in patients with severe constipation, bowel obstruction, or fecal impaction, including abnormal postoperative bowel motility disorders, because the drug may not be effective and may worsen GI conditions.1
Hypomagnesemia was reported in 5.3% of adults receiving patiromer in clinical studies.1 Patiromer binds to magnesium in the colon, which can lead to hypomagnesemia.1 Serum magnesium concentrations should be monitored in patients receiving patiromer, and magnesium supplementation should be considered in those with low serum magnesium concentrations.1
Patiromer is not expected to cause fetal harm when administered to pregnant women because the drug is not absorbed systemically following oral administration.1
Breast-feeding is not expected to result in risk to infants of patiromer-treated women because the drug is not absorbed systemically following oral administration.1
Safety and efficacy of patiromer for the treatment of hyperkalemia have been established in pediatric patients 12 years of age or older.1 Use of the drug in pediatric patients is supported by an adequate and well-controlled study in adults as well as pharmacodynamic and safety data from a single-arm, open-label study in pediatric patients 12-17 years of age.1
Safety and efficacy of patiromer have not been established in pediatric patients younger than 12 years of age.1 Although there were some patients 6 to less than 12 years of age in the open-label pediatric study, the available data are not sufficient to determine a safe and effective dosing regimen for this pediatric age group.1
In clinical studies of patiromer, 60% of patients receiving the drug were 65 years of age or older, while 20% were 75 years of age or older.1 No overall differences in efficacy were observed between geriatric patients and younger adults.1 However, adverse GI effects were reported more frequently in those 65 years of age or older compared with younger patients.1
In clinical studies of patiromer, 93% of adults receiving the drug had chronic kidney disease.1 All of the pediatric patients who were included in the pediatric study of patiromer had chronic kidney disease.1 No dosage adjustments are necessary in patients with renal impairment.1
The most common adverse effects reported with patiromer in clinical studies (incidence ≥2%) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.1
Effects on GI Absorption of Drugs
Patiromer can bind to some orally administered drugs, potentially decreasing GI absorption of the co-administered drug.1, 10
In vitro binding of patiromer may reduce systemic exposure and decrease clinical efficacy of the following drugs: telmisartan, bisoprolol, carvedilol, nebivolol, ciprofloxacin, levothyroxine, metformin, mycophenolate mofetil, quinidine, and thiamine.1 Administration of these drugs should be separated by at least 3 hours from patiromer.1
Clinically meaningful in vitro binding has not been observed between patiromer and the following drugs, and therefore no separation of dosing from patiromer is required: ACE inhibitors (benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril), angiotensin II receptor blockers (azilsartan, candesartan, irbesartan, losartan, olmesartan, valsartan), metoprolol, furosemide, bumetanide, torsemide, eplerenone, finerenone, spironolactone, sacubitril, canagliflozin, dapagliflozin, empagliflozin, trimethoprim, amoxicillin, cephalexin, warfarin, apixaban, rivaroxaban, cinacalcet, clopidogrel, acetylsalicylic acid, glipizide, amlodipine, verapamil, tacrolimus, lithium, allopurinol, atorvastatin, digoxin, phenytoin, riboflavin, and sevelamer.1 For other oral drugs not listed, administration of patiromer should be separated by at least 3 hours as a precautionary measure.1
Patiromer sorbitex calcium, which consists of patiromer, a nonabsorbed cation-exchange polymer, and a calcium-sorbitol counterion, is used for the removal of excess potassium.1, 3, 5, 7 The drug increases fecal potassium excretion via binding of potassium in the lumen of the GI tract, which decreases the concentration of free potassium in the GI lumen and, consequently, reduces serum potassium concentrations.1 Animal studies indicate that orally administered patiromer is not absorbed systemically and is excreted in feces.1, 6
In an open-label study in patients with chronic kidney disease and hyperkalemia (mean baseline serum potassium concentration of 5.9 mEq/L), serum potassium concentrations were reduced by 0.2 and 0.8 mEq/L at 7 and 48 hours, respectively, following initiation of therapy with patiromer (16.8 g daily in divided doses for 2 days); potassium concentrations remained stable for 24 hours after the last dose and then began to increase.1, 7 Following twice-daily dosing, maximum (steady-state) effects on serum potassium concentration are attained in approximately 7-14 days.8
In healthy individuals, patiromer produced a dose-dependent increase in fecal potassium excretion with a corresponding dose-dependent decrease in urinary potassium excretion, resulting in no change in serum potassium concentrations, when administered at dosages up to 50.4 g daily in 3 divided doses for 8 days.1 Substantial increases in mean daily fecal potassium excretion with concomitant decreases in mean daily urinary potassium excretion also were observed in healthy individuals receiving patiromer 25.2 g daily for 6 days; fecal and urinary potassium excretion were similar whether the drug was administered as a single daily dose or in 2 or 3 divided doses daily.1 Mean patiromer dosage and effects of the drug on serum potassium concentration are similar whether patiromer is administered with or without food.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | For suspension | 1 g (of patiromer) per packet | Vifor Pharma | |
8.4 g (of patiromer) per packet | Veltassa® | Vifor Pharma | ||
16.8 g (of patiromer) per packet | Veltassa® | Vifor Pharma | ||
25.2 g (of patiromer) per packet | Veltassa® | Vifor Pharma |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions June 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Vifor Pharma. Veltassa® (patiromer) powder for oral suspension prescribing information. King of Prussia, PA; 2025 Jan.
3. Weir MR, Bakris GL, Bushinsky DA et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med . 2015; 372:211-21. [PubMed 25415805]
4. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Summary review. From FDA website. [Web]
5. Bakris GL, Pitt B, Weir MR et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA . 2015; 314:151-61. [PubMed 26172895]
6. Li L, Harrison SD, Cope MJ et al. Mechanism of action and pharmacology of patiromer, a nonabsorbed cross-linked polymer that lowers serum potassium concentration in patients with hyperkalemia. J Cardiovasc Pharmacol Ther . 2016; [PubMed 26856345]
7. Bushinsky DA, Williams GH, Pitt B et al. Patiromer induces rapid and sustained potassium lowering in patients with chronic kidney disease and hyperkalemia. Kidney Int . 2015; 88:1427-1433. [PubMed 26376130]
8. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. [Web]
9. Palmer BF, Carrero JJ, Clegg DJ et al. Clinical Management of Hyperkalemia. Mayo Clin Proc. 2021 Mar;96(3):744-762. doi: 10.1016/j.mayocp.2020.06.014. Epub 2020 Nov 5. PMID: 33160639.
10. Lesko LJ, Offman E, Brew CT et al. Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers. J Cardiovasc Pharmacol Ther . 2017; 22:434-446. [PubMed 28585859]
11. Rafique Z, Weir MR, Onuigbo M et al. Expert Panel Recommendations for the Identification and Management of Hyperkalemia and Role of Patiromer in Patients with Chronic Kidney Disease and Heart Failure. J Manag Care Spec Pharm. 2017 Apr;23(4-a Suppl):S10-S19. doi: 10.18553/jmcp.2017.23.4-a.s10. PMID: 28485203; PMCID: PMC10408402.
12. National Kidney Foundation. Best practices in managing hyperkalemia in chronic kidney disease. From the National Kidney Foundation website. Accessed March 31, 2025.