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WHEN TREATING HYPERKALEMIA


CHOOSE LOKELMA

THE #1 K+ BINDER PRESCRIBED BY NEPHROLOGISTS1

EFFICACY:

EFFICACY:

Discover a different path to managing hyperkalemia

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DOSING:

DOSING:

Choose a K+ binder that is tasteless and odorless2,3

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ACCESS & SAVINGS:

ACCESS & SAVINGS:

Help patients access and save on their prescriptions

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MECHANISM OF ACTION

MECHANISM OF ACTION:

Explore how this innovative K+ binder works differently

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IN ADULT PATIENTS WITH HYPERKALEMIA NOT ON DIALYSIS


CHOOSE THE PATH TO RAPID* AND SUSTAINED† K+ CONTROL2-4

 

LEARN HOW LOKELMA CAN HELP

TREAT YOUR PATIENTS WITH HK



 

 

INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

limitation of use: LOKELMA should not be used as an emergency treatment for
life-threatening hyperkalemia because of its delayed onset of action.

 

*In Study 1, LOKELMA 10 g tid demonstrated a greater reduction in serum K+
levels vs placebo at 48 hours (P<0.001) and started to work as early as 1 hour
in patients with hyperkalemia not on dialysis.2,4

†In Study 2, patients with hyperkalemia who achieved normokalemia (K+=3.5–5.0
mEq/L) with LOKELMA in the 48-hour initial phase entered into the 28-day
maintenance phase, where those who continued LOKELMA maintained lower mean serum
K+ levels vs those who switched to placebo, with a greater proportion of
patients having mean serum K+ in the normal range with LOKELMA vs placebo.
Patients in Study 2 who continued into the open-label, 11-month extension phase
sustained normokalemia with continued LOKELMA dosing.2 

 






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INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening
hyperkalemia because of its delayed onset of action.


IMPORTANT SAFETY INFORMATION FOR LOKELMA® (SODIUM ZIRCONIUM CYCLOSILICATE)


WARNINGS AND PRECAUTIONS:

 * Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid
   LOKELMA in patients with severe constipation, bowel obstruction or impaction,
   including abnormal post-operative bowel motility disorders. LOKELMA has not
   been studied in patients with these conditions and it may be ineffective and
   may worsen gastrointestinal conditions
 * Edema: Each 5-g dose of LOKELMA contains approximately 400 mg of sodium, but
   the extent of absorption by the patient is unknown. 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. Monitor for signs of edema, particularly in
   patients who should restrict their sodium intake or are prone to fluid
   overload (eg, heart failure or renal disease). Advise patients to adjust
   dietary sodium, if appropriate. Increase the dose of diuretics as needed
   
   In a clinical trial of LOKELMA in patients on chronic hemodialysis in which
   most patients were treated with doses of 5 g to 10 g once daily on
   non-dialysis days, there was no difference in the mean change from baseline
   in interdialytic weight gain (a measure of fluid retention) between the
   LOKELMA and placebo groups

 * Hypokalemia in Patients on Hemodialysis: Patients on hemodialysis may be
   prone to acute illness that can increase the risk of hypokalemia on LOKELMA
   (eg, illnesses associated with decreased oral intake, diarrhea). Consider
   adjusting LOKELMA dose based on potassium levels in these settings
 * Diagnostic Tests: LOKELMA has radio-opaque properties and, therefore, may
   give the appearance typical of an imaging agent during abdominal X-ray
   procedures

 

ADVERSE REACTIONS: The most common adverse reaction in non-dialysis patients
with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28
days, edema was reported in 4.4%, 5.9%, 16.1% of non-dialysis patients treated
with 5 g, 10 g, and 15 g of LOKELMA once daily, respectively vs 2.4% of
non-dialysis patients receiving placebo.

DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral
medications with pH-dependent solubility should be administered at least 2 hours
before or 2 hours after LOKELMA. Spacing is not needed if it has been determined
the concomitant medication does not exhibit pH-dependent solubility.


INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening
hyperkalemia because of its delayed onset of action.



PLEASE READ FULL PRESCRIBING INFORMATION FOR LOKELMA.

You may report side effects related to AstraZeneca products.



K+=potassium; tid=3 times a day.

References: 1. Data on File, US-53732. AZPLP. 2. LOKELMA® (sodium zirconium
cyclosilicate) [prescribing information]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; 2022. 3. Kosiborod M, Rasmussen HS, Lavin P, et al. Effect
of sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. doi:10.1001/jama.2014.15688 4. Packham DK, Rasmussen HS,
Lavin PT, et al. Sodium zirconium cyclosilicate in hyperkalemia [article and
supplementary material]. N Engl J Med. 2015;372(3):222-231.
doi:10.1056/NEJMoa1411487

References: 1. Dunn JD, Benton WW, Orozco-Torrentera E, Adamson RT. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15):S307-S315. 2. Data on File, REF-34835. AZPLP. 3. Collins AJ,
Pitt B, Reaven N, et al. Association of serum potassium with all-cause mortality
in patients with and without heart failure, chronic kidney disease, and/or
diabetes. Am J Nephrol. 2017;46(3):213-221. 4. Collins AJ, Pitt B, Reaven N, et
al. Association of serum potassium with all-cause mortality in patients with and
without heart failure, chronic kidney disease, and/or diabetes. Am J Nephrol.
2017;46(3 Suppl):S1-S13. 5. LOKELMA® (sodium zirconium cyclosilicate)
[prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022.
6. Betts KA, Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The cost of hyperkalemia
in the United States. Kidney Int Rep. 2018;3(2):385-393. 7. Cupisti A, Kovesdy
CP, D'Alessandro C, et al. Dietary approach to recurrent or chronic
hyperkalaemia in patients with decreased kidney function. Nutrients.
2018;10(261):1-159. 8. Ikizler TA, Burrowes JD, Byham-Gray LD, et al. KDOQI
Nutrition in CKD Guideline Work Group. KDOQI clinical practice guideline for
nutrition in CKD: 2020 update. Am J Kidney Dis. 2020;76(3)(suppl 1):S1-S107. 9.
Palmer BF, Carrero JJ, Clegg DJ, et al. Clinical management of hyperkalemia.
Mayo Clin Proc. 2021;96(3):744-762. 10. Downer MK, Gea A, Stampfer M, et al.
Predictors of short- and long-term adherence with a Mediterranean-type diet
intervention: the PREDIMED randomized trial. Int J Behav Nutr Phys Act.
2016;13:67. 11. Epstein M, Reaven NL, Funk SE, McGaughey KJ, Oestreicher N,
Knispel J. Evaluation of the treatment gap between clinical guidelines and the
utilization of renin-angiotensin-aldosterone system inhibitors. Am J Manag Care.
2015;21(11 suppl):S212-S220. 12. Kidney Disease: Improving Global Outcomes
(KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes
Management in Chronic Kidney Disease. Kidney Int. 2020;98(4S):S1-S115. 13.
Kidney Disease: Improving Global Outcomes. KDIGO 2021 Clinical Practice
Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney
Int. 2021;99(3S):S1-S87. 14. Hollander-Rodriguez JC, Calvert JF Jr.
Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 15. Weisberg LS. Management
of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251. 16. Parham WA,
Mehdirad AA, Biermann KM, Fredman CS. Hyperkalemia revisited. Tex Heart Inst J.
2006;33(1):40-47. 17. Palmer BF. Regulation of potassium homeostasis. Clin J Am
Soc Nephrol. 2015;10:1050-1060. 18. Mushiyakh Y, Dangaria H, Qavi S, Ali N,
Pannone J, Tompkins D. Treatment and pathogenesis of acute hyperkalemia. J
Community Hosp Intern Med. 19. Rafique Z, Peacock F, Armstead T, et al.
Hyperkalemia management in the emergency department: An expert panel consensus.
JACEP Open. 2021;2:e12572.

Ca2+=calcium; GI=gastrointestinal; K+=potassium; Mg2+=magnesium; MOA=mechanism
of action; qod=every other day; SPS=sodium polystyrene sulfonate.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Stavros
F, Yang A, Leon A, Nuttall M, Rasmussen HS. Characterization of structure and
function of ZS-9, a K+ selective ion trap. PLoS One. 2014;9(12):e114686. 3.
Kayexalate® (sodium polystyrene sulfonate) [prescribing information]. St.
Michael, Barbados: Concordia Pharmaceuticals Inc; 2017. 4. Veltassa® (patiromer)
[prescribing information]. Redwood City, CA: Relypsa, Inc; 2023. 5. Pitt B,
Bakris GL. New potassium binders for the treatment of hyperkalemia: current data
and opportunities for the future. Hypertension. 2015;66(4):731-738. 6. Palmer
BF. Potassium binders for hyperkalemia in chronic kidney disease–diet,
renin-angiotensin-aldosterone system inhibitor therapy, and hemodialysis. Mayo
Clin Proc. 2020;95(2):339-354. 7. Clegg DJ, Cody M, Palmer BF. Challenges in
treating cardiovascular disease: restricting sodium and managing hyperkalemia.
Mayo Clin Proc. 2017;92(8):1248-1260. 8. Lien YH. Patiromer: Can less be better
than more? Am J Med. 2018;131(5):459-460. 9. Beccari MV, Meaney CJ. Clinical
utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene
sulfonate for the treatment of hyperkalemia: an evidence-based review. Core
Evid. 2017;12:11-24. 10. Sodium Polystyrene Sulfonate Suspension [package
insert]. Farmville, North Carolina: CMP Pharma Inc; 2021. 11. 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;21(5):456-465.

K+=potassium; LIDI=long interdialytic interval; qd=once daily; qod=every other
day; SIDI=short interdialytic interval; tid=three times daily.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Packham
DK, Rasmussen HS, Lavin PT, et al. Sodium zirconium cyclosilicate in
hyperkalemia [article and supplementary material]. N Engl J Med.
2015;372(3):222-231. 3. Kosiborod M, Rasmussen HS, Lavin P, et al. Effect of
sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. 4. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480. 5.
Data on file, US-73614, AZPLP. 6. Fishbane S, Ford M, Fukagawa M, et al. A phase
3b, randomized, double-blind, placebo-controlled study of sodium zirconium
cyclosilicate for reducing the incidence of predialysis hyperkalemia. J Am Soc
Nephrol. 2019;30(9):1723-1733.

CKD=chronic kidney disease; DM=diabetes mellitus; GI=gastrointestinal; HF=heart
failure; HTN=hypertension; K+= potassium; qd=once daily; SAEs=serious adverse
events.References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Spinowitz
BS, Fishbane S, Pergola PE, et al. Sodium zirconium cyclosilicate among
individuals with hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 3. U.S. Food & Drug Administration. Drug Approval Package:
LOKELMA (sodium zirconium cyclosilicate) Medical Review(s). Accessed September
19, 2023.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207078Orig1s000MedR.pdf
4. Fishbane S, Ford M, Fukagawa M, et al. A phase 3b, randomized, double-blind,
placebo-controlled study of sodium zirconium cyclosilicate for reducing the
incidence of predialysis hyperkalemia. J Am Soc Nephrol. 2019;30(9):1723-1733.

K+=potassium; LIDI=long interdialytic interval; qod=every other day;
RAASi=renin-angiotensin-aldosterone system inhibitor; tbsp=tablespoon.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Kosiborod
M, Rasmussen HS, Lavin P, et al. Effect of sodium zirconium cyclosilicate on
potassium lowering for 28 days among outpatients with hyperkalemia: the
HARMONIZE randomized clinical trial. JAMA. 2014;312(21):2223-2233. 3. Packham
DK, Rasmussen HS, Lavin PT, et al. Sodium zirconium cyclosilicate in
hyperkalemia [article and supplementary material]. N Engl J Med.
2015;372(3):222-231. 4. Spinowitz BS, Fishbane S, Pergola PE, et al; ZS-005
Study Investigators. Sodium zirconium cyclosilicate among individuals with
hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 5. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480.

References: 1. Spinowitz BS, Fishbane S, Pergola PE, et al; ZS-005 Study
Investigators. Sodium zirconium cyclosilicate among individuals with
hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 2. Packham DK, Rasmussen HS, Lavin PT, et al. Sodium
zirconium cyclosilicate in hyperkalemia [article and supplementary material]. N
Engl J Med. 2015;372(3):222-231. 3. Kosiborod M, Rasmussen HS, Lavin P, et al.
Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. 4. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480. 5.
LOKELMA® (sodium zirconium cyclosilicate) [prescribing information]. Wilmington,
DE: AstraZeneca Pharmaceuticals LP; 2022. 6. Data on file, US-53732, AZPLP.

References: 1. Dunn JD, Benton WW, Orozco-Torrentera E, Adamson RT. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15 Suppl):s307-s315. 2. Data on File, REF-34835. AZPLP.  3.
Collins AJ, Pitt B, Reaven N, et al. Association of serum potassium with
all-cause mortality in patients with and without heart failure, chronic kidney
disease, and/or diabetes. Am J Nephrol. 2017;46(3):213-221.
doi:10.1159/000479802 4. Collins AJ, Pitt B, Reaven N, et al. Association of
serum potassium with all-cause mortality in patients with and without heart
failure, chronic kidney disease, and/or diabetes. Am J Nephrol. 2017;46(3
Suppl):S1-S13. 5. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 6. Betts KA,
Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The cost of hyperkalemia in the United
States. Kidney Int Rep. 2018;3(2):385-393 2017;46(3):213-221.
doi:10.1016/j.ekir.2017.11.003 7. Epstein M, Reaven NL, Funk SE, McGaughey KJ,
Oestreicher N, Knispel J. Evaluation of the treatment gap between clinical
guidelines and the utilization of renin-angiotensin-aldosterone system
inhibitors. Am J Manag Care. 2015;21(11 suppl):S212-S220. 8. Kidney Disease:
Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical
Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney
Int. 2022;102(5S):S1-S127. doi:10.10 S220. 816/j.kint.2022.06.008 9. Kidney
Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020
Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease.
Kidney Int. 2020;98(4S):S1-S115. doi:10.1016/j.kint.2020.06.019 10. Kidney
Disease: Improving Global Outcomes. KDIGO 2021 Clinical Practice Guideline for
the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int.
2021;99(3S):S1-S87. doi:10.1016/j.kint.2020.11.003 11. Hollander-Rodriguez JC,
Calvert JF Jr. Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 12. Weisberg
LS. Management of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251.
doi:10.1097/CCM.0b013e31818f222b 13. Parham WA, Mehdirad AA, Biermann KM,
Fredman CS. Hyperkalemia revisited. Tex Heart Inst J. 2006;33(1):40-47. 14.
Palmer BF. Regulation of potassium homeostasis. Clin J Am Soc Nephrol.
2015;10(6):1050-1060. doi:102215/CJN.08580813 15. Mushiyakh Y, Dangaria H, Qavi
S, Ali N, Pannone J, Tompkins D. Treatment and pathogenesis of acute
hyperkalemia. J Community Hosp Intern Med Perspect.
2012;1(14):10.3402/jchimp.v1i4.732. doi:10.3402/jchimp.vi4.7372 16. Rafique Z,
Peacock F, Armstead T, et al. Hyperkalemia management in the emergency
department: An expert panel consensus. J Am Coll Emerg Physicians Open.
2021;2(5):e12572. doi:10.1002/emp2.12572

CKD=chronic kidney disease; DM=diabetes mellitus; HF=heart failure;
HTN=hypertension; K+=potassium; MOA=mechanism of action;
RAASi=renin-angiotensin-aldosterone system inhibitor.References: 1. Epstein M,
Reaven NL, Funk SE, et al. Evaluation of the treatment gap between clinical
guidelines and the utilization of renin-angiotensin-aldosterone system
inhibitors. Am J Manag Care. 2015;21:S212-S220. 2. Kidney Disease: Improving
Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice
Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int.
2020;98(4S):S1-S115. 3. Kidney Disease: Improving Global Outcomes. KDIGO 2021
Clinical Practice Guideline for the Management of Blood Pressure in Chronic
Kidney Disease. Kidney Int. 2021;99(3S):S1-S87. 4. Data on File, US-53732,
AZPLP.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; BP=blood pressure; CKD=chronic kidney disease; ED=emergency department;
GI=gastrointestinal; HbA1c=glycated hemoglobin; K+=potassium;
RAASi=renin-angiotensin-aldosterone system inhibitor; SPS=sodium polystyrene
sulfonate. Reference: 1. Data on File, US-53732, AZPLP.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; ARNI=angiotensin receptor-neprilysin inhibitor; HK=hyperkalemia; K+=
potassium; MRA=mineralocorticoid receptor antagonist; qod=every other day;
qd=once daily; RAASi=renin-angiotensin-aldosterone system; RWE=real-world
evidence; tid=three times daily; US=United States.References: 1. LOKELMA®
(sodium zirconium cyclosilicate) [prescribing information]. Wilmington, DE:
AstraZeneca Pharmaceuticals LP; 2022. 2. Kidney Disease: Improving Global
Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for
Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S):S1-S127.
doi:10.1016/j.kint.2022.06.008 3. Kidney Disease: Improving Global Outcomes
(KDIGO) Blood Pressure Work Group. KDIGO 2021 clinical practice guideline for
the management of blood pressure in chronic kidney disease. Kidney Int.
2021;99(3S):S1-S87. doi:101016/j.kint.2020.11.003 4. Heidenreich PA, Bozkurt B,
Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart
failure: a report of the American College of Cardiology/American Heart
Association Joint Committee on Clinical Practice Guidelines. Circulation.
2022;145(18):e895-e1032. 5. Spinowitz BS, Fishbane S, Pergola PE, et al. Sodium
zirconium cyclosilicate among individuals with hyperkalemia: a 12-month phase 3
study. Clin J Am Soc Nephrol. 2019;14(6):798-809. doi:10.2215/CJN.12651018 6.
Agiro A, Amin A, Cook EE, et al. Real-world modifications of
renin-angiotensin-aldosterone system inhibitors in patients with hyperkalemia
initiating sodium zirconium cyclosilicate therapy: the OPTIMIZE I study. Adv
Ther. 2023;40(6):2886–2901.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; ARNI=angiotensin receptor-neprilysin inhibitor; CI=confidence interval;
CKD=chronic kidney disease; DM=diabetes mellitus; ECG=electrocardiogram;
ED=emergency department; eGFR=estimated glomerular filtration rate;
EHR=electronic health records; GI=gastrointestinal; HF=heart failure;
HK=hyperkalemia; IDN=integrated delivery network; K+= potassium; KDIGO=Kidney
Disease: Improving Global Outcomes; MI=myocardial infarction; MNT=medical
nutrition therapy; MRA=mineralocorticoid receptor antagonist; NA+=sodium;
RAASi=renin-angiotensin-aldosterone system inhibitor; RWE=real world evidence;
SD=standard deviation; SPS=sodium polystyrene sulfonate. References: 1. Collins
AJ, Pitt B, Reaven N, et al. Association of serum potassium with all-cause
mortality in patients with and without heart failure, chronic kidney disease,
and/or diabetes. Am J Nephrol. 2017;46(3):213-221. 2. LOKELMA® (sodium zirconium
cyclosilicate) [prescribing information]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; 2022. 3. Collins AJ, Pitt B, Reaven N, et al. Association of
serum potassium with all-cause mortality in patients with and without heart
failure, chronic kidney disease, and/or diabetes. Am J Nephrol. 2017;46(3
Suppl):S1-S13. 4. Epstein M, Reaven NL, Funk SE, et al. Evaluation of the
treatment gap between clinical guidelines and the utilization of
renin-angiotensin-aldosterone system inhibitors. Am J Manag Care. 2015;21(11
Suppl):S212-S220. 5. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes
Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in
Chronic Kidney Disease. Kidney Int. 2020;98(4S):S1-S115. 6. Kidney Disease:
Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical
Practice Guideline for the Management of Blood Pressure in Chronic Kidney
Disease. Kidney Int. 2021;99(3S):S1-S87. 7. Rowan CG, Agiro A, Chan A, et al.
Recurrence of hyperkalemia following dietary counseling: REVOLUTIONIZE I
real-world evidence study. Presented at: National Kidney Foundation (NFK) Spring
Clinical Meetings 2023; April 11-15, 2023. Poster 296. 8. Data on File,
REF-178557, AZPLP. 9. An J, Zhou H, Ni L, et al. Discontinuation of
renin-angiotensin-aldosterone system inhibitors secondary to hyperkalemia
translates into higher cardiorenal outcomes. Am J Nephrol. Published online May
18, 2023. doi:10.1159/000531102 10. Kidney Disease: Improving Global Outcomes
(KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes
Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S):S1-S127.
doi:10.1016/j.kint.2022.06.008 11. Hollander-Rodriguez JC and Calvert JF Jr.
Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 12. Weisberg LS. Management
of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251. 13. Parham WA,
Mehdirad AA, Biermann KM, et al. Hyperkalemia revisited. Tex Heart Inst J.
2006;33(1):40-47. 14. Dunn JD, Benton WW, Orozco-Torrentera E, et al. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15 Suppl):s307-s315. 15. Palmer BF. Regulation of potassium
homeostasis. Clin J Am Soc Nephrol. 2015;10:1050-1060. 16. Mushiyakh Y, Dangaria
H, Qavi S, et al. Treatment and pathogenesis of acute hyperkalemia. J Community
Hosp Intern Med Perspect. 2012;1(4):7372. doi:10.3402/jchimp.v1i4.7372 17.
Rafique Z, Peacock F, Armstead T, et al. Hyperkalemia management in the
emergency department: An expert panel consensus. J Am Coll Emerg Physicians
Open. 2021;2(5):e12572. doi:10.1002/emp2.12572




INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening
hyperkalemia because of its delayed onset of action.


IMPORTANT SAFETY INFORMATION FOR LOKELMA® (SODIUM ZIRCONIUM CYCLOSILICATE)


WARNINGS AND PRECAUTIONS:

 * Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid
   LOKELMA in patients with severe constipation, bowel obstruction or impaction,
   including abnormal post-operative bowel motility disorders. LOKELMA has not
   been studied in patients with these conditions and it may be ineffective and
   may worsen gastrointestinal conditions
 * Edema: Each 5-g dose of LOKELMA contains approximately 400 mg of sodium, but
   the extent of absorption by the patient is unknown. 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. Monitor for signs of edema, particularly in
   patients who should restrict their sodium intake or are prone to fluid
   overload (eg, heart failure or renal disease). Advise patients to adjust
   dietary sodium, if appropriate. Increase the dose of diuretics as needed
   
   In a clinical trial of LOKELMA in patients on chronic hemodialysis in which
   most patients were treated with doses of 5 g to 10 g once daily on
   non-dialysis days, there was no difference in the mean change from baseline
   in interdialytic weight gain (a measure of fluid retention) between the
   LOKELMA and placebo groups

 * Hypokalemia in Patients on Hemodialysis: Patients on hemodialysis may be
   prone to acute illness that can increase the risk of hypokalemia on LOKELMA
   (eg, illnesses associated with decreased oral intake, diarrhea). Consider
   adjusting LOKELMA dose based on potassium levels in these settings
 * Diagnostic Tests: LOKELMA has radio-opaque properties and, therefore, may
   give the appearance typical of an imaging agent during abdominal X-ray
   procedures

 

ADVERSE REACTIONS: The most common adverse reaction in non-dialysis patients
with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28
days, edema was reported in 4.4%, 5.9%, 16.1% of non-dialysis patients treated
with 5 g, 10 g, and 15 g of LOKELMA once daily, respectively vs 2.4% of
non-dialysis patients receiving placebo.

DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral
medications with pH-dependent solubility should be administered at least 2 hours
before or 2 hours after LOKELMA. Spacing is not needed if it has been determined
the concomitant medication does not exhibit pH-dependent solubility.


INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening
hyperkalemia because of its delayed onset of action.



PLEASE READ FULL PRESCRIBING INFORMATION FOR LOKELMA.

You may report side effects related to AstraZeneca products.



K+=potassium; tid=3 times a day.

References: 1. Data on File, US-53732. AZPLP. 2. LOKELMA® (sodium zirconium
cyclosilicate) [prescribing information]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; 2022. 3. Kosiborod M, Rasmussen HS, Lavin P, et al. Effect
of sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. doi:10.1001/jama.2014.15688 4. Packham DK, Rasmussen HS,
Lavin PT, et al. Sodium zirconium cyclosilicate in hyperkalemia [article and
supplementary material]. N Engl J Med. 2015;372(3):222-231.
doi:10.1056/NEJMoa1411487

References: 1. Dunn JD, Benton WW, Orozco-Torrentera E, Adamson RT. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15):S307-S315. 2. Data on File, REF-34835. AZPLP. 3. Collins AJ,
Pitt B, Reaven N, et al. Association of serum potassium with all-cause mortality
in patients with and without heart failure, chronic kidney disease, and/or
diabetes. Am J Nephrol. 2017;46(3):213-221. 4. Collins AJ, Pitt B, Reaven N, et
al. Association of serum potassium with all-cause mortality in patients with and
without heart failure, chronic kidney disease, and/or diabetes. Am J Nephrol.
2017;46(3 Suppl):S1-S13. 5. LOKELMA® (sodium zirconium cyclosilicate)
[prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022.
6. Betts KA, Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The cost of hyperkalemia
in the United States. Kidney Int Rep. 2018;3(2):385-393. 7. Cupisti A, Kovesdy
CP, D'Alessandro C, et al. Dietary approach to recurrent or chronic
hyperkalaemia in patients with decreased kidney function. Nutrients.
2018;10(261):1-159. 8. Ikizler TA, Burrowes JD, Byham-Gray LD, et al. KDOQI
Nutrition in CKD Guideline Work Group. KDOQI clinical practice guideline for
nutrition in CKD: 2020 update. Am J Kidney Dis. 2020;76(3)(suppl 1):S1-S107. 9.
Palmer BF, Carrero JJ, Clegg DJ, et al. Clinical management of hyperkalemia.
Mayo Clin Proc. 2021;96(3):744-762. 10. Downer MK, Gea A, Stampfer M, et al.
Predictors of short- and long-term adherence with a Mediterranean-type diet
intervention: the PREDIMED randomized trial. Int J Behav Nutr Phys Act.
2016;13:67. 11. Epstein M, Reaven NL, Funk SE, McGaughey KJ, Oestreicher N,
Knispel J. Evaluation of the treatment gap between clinical guidelines and the
utilization of renin-angiotensin-aldosterone system inhibitors. Am J Manag Care.
2015;21(11 suppl):S212-S220. 12. Kidney Disease: Improving Global Outcomes
(KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes
Management in Chronic Kidney Disease. Kidney Int. 2020;98(4S):S1-S115. 13.
Kidney Disease: Improving Global Outcomes. KDIGO 2021 Clinical Practice
Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney
Int. 2021;99(3S):S1-S87. 14. Hollander-Rodriguez JC, Calvert JF Jr.
Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 15. Weisberg LS. Management
of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251. 16. Parham WA,
Mehdirad AA, Biermann KM, Fredman CS. Hyperkalemia revisited. Tex Heart Inst J.
2006;33(1):40-47. 17. Palmer BF. Regulation of potassium homeostasis. Clin J Am
Soc Nephrol. 2015;10:1050-1060. 18. Mushiyakh Y, Dangaria H, Qavi S, Ali N,
Pannone J, Tompkins D. Treatment and pathogenesis of acute hyperkalemia. J
Community Hosp Intern Med. 19. Rafique Z, Peacock F, Armstead T, et al.
Hyperkalemia management in the emergency department: An expert panel consensus.
JACEP Open. 2021;2:e12572.

Ca2+=calcium; GI=gastrointestinal; K+=potassium; Mg2+=magnesium; MOA=mechanism
of action; qod=every other day; SPS=sodium polystyrene sulfonate.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Stavros
F, Yang A, Leon A, Nuttall M, Rasmussen HS. Characterization of structure and
function of ZS-9, a K+ selective ion trap. PLoS One. 2014;9(12):e114686. 3.
Kayexalate® (sodium polystyrene sulfonate) [prescribing information]. St.
Michael, Barbados: Concordia Pharmaceuticals Inc; 2017. 4. Veltassa® (patiromer)
[prescribing information]. Redwood City, CA: Relypsa, Inc; 2023. 5. Pitt B,
Bakris GL. New potassium binders for the treatment of hyperkalemia: current data
and opportunities for the future. Hypertension. 2015;66(4):731-738. 6. Palmer
BF. Potassium binders for hyperkalemia in chronic kidney disease–diet,
renin-angiotensin-aldosterone system inhibitor therapy, and hemodialysis. Mayo
Clin Proc. 2020;95(2):339-354. 7. Clegg DJ, Cody M, Palmer BF. Challenges in
treating cardiovascular disease: restricting sodium and managing hyperkalemia.
Mayo Clin Proc. 2017;92(8):1248-1260. 8. Lien YH. Patiromer: Can less be better
than more? Am J Med. 2018;131(5):459-460. 9. Beccari MV, Meaney CJ. Clinical
utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene
sulfonate for the treatment of hyperkalemia: an evidence-based review. Core
Evid. 2017;12:11-24. 10. Sodium Polystyrene Sulfonate Suspension [package
insert]. Farmville, North Carolina: CMP Pharma Inc; 2021. 11. 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;21(5):456-465.

K+=potassium; LIDI=long interdialytic interval; qd=once daily; qod=every other
day; SIDI=short interdialytic interval; tid=three times daily.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Packham
DK, Rasmussen HS, Lavin PT, et al. Sodium zirconium cyclosilicate in
hyperkalemia [article and supplementary material]. N Engl J Med.
2015;372(3):222-231. 3. Kosiborod M, Rasmussen HS, Lavin P, et al. Effect of
sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. 4. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480. 5.
Data on file, US-73614, AZPLP. 6. Fishbane S, Ford M, Fukagawa M, et al. A phase
3b, randomized, double-blind, placebo-controlled study of sodium zirconium
cyclosilicate for reducing the incidence of predialysis hyperkalemia. J Am Soc
Nephrol. 2019;30(9):1723-1733.

CKD=chronic kidney disease; DM=diabetes mellitus; GI=gastrointestinal; HF=heart
failure; HTN=hypertension; K+= potassium; qd=once daily; SAEs=serious adverse
events.References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Spinowitz
BS, Fishbane S, Pergola PE, et al. Sodium zirconium cyclosilicate among
individuals with hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 3. U.S. Food & Drug Administration. Drug Approval Package:
LOKELMA (sodium zirconium cyclosilicate) Medical Review(s). Accessed September
19, 2023.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207078Orig1s000MedR.pdf
4. Fishbane S, Ford M, Fukagawa M, et al. A phase 3b, randomized, double-blind,
placebo-controlled study of sodium zirconium cyclosilicate for reducing the
incidence of predialysis hyperkalemia. J Am Soc Nephrol. 2019;30(9):1723-1733.

K+=potassium; LIDI=long interdialytic interval; qod=every other day;
RAASi=renin-angiotensin-aldosterone system inhibitor; tbsp=tablespoon.

References: 1. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 2. Kosiborod
M, Rasmussen HS, Lavin P, et al. Effect of sodium zirconium cyclosilicate on
potassium lowering for 28 days among outpatients with hyperkalemia: the
HARMONIZE randomized clinical trial. JAMA. 2014;312(21):2223-2233. 3. Packham
DK, Rasmussen HS, Lavin PT, et al. Sodium zirconium cyclosilicate in
hyperkalemia [article and supplementary material]. N Engl J Med.
2015;372(3):222-231. 4. Spinowitz BS, Fishbane S, Pergola PE, et al; ZS-005
Study Investigators. Sodium zirconium cyclosilicate among individuals with
hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 5. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480.

References: 1. Spinowitz BS, Fishbane S, Pergola PE, et al; ZS-005 Study
Investigators. Sodium zirconium cyclosilicate among individuals with
hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol.
2019;14(6):798-809. 2. Packham DK, Rasmussen HS, Lavin PT, et al. Sodium
zirconium cyclosilicate in hyperkalemia [article and supplementary material]. N
Engl J Med. 2015;372(3):222-231. 3. Kosiborod M, Rasmussen HS, Lavin P, et al.
Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among
outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. 4. Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and
safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an
11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480. 5.
LOKELMA® (sodium zirconium cyclosilicate) [prescribing information]. Wilmington,
DE: AstraZeneca Pharmaceuticals LP; 2022. 6. Data on file, US-53732, AZPLP.

References: 1. Dunn JD, Benton WW, Orozco-Torrentera E, Adamson RT. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15 Suppl):s307-s315. 2. Data on File, REF-34835. AZPLP.  3.
Collins AJ, Pitt B, Reaven N, et al. Association of serum potassium with
all-cause mortality in patients with and without heart failure, chronic kidney
disease, and/or diabetes. Am J Nephrol. 2017;46(3):213-221.
doi:10.1159/000479802 4. Collins AJ, Pitt B, Reaven N, et al. Association of
serum potassium with all-cause mortality in patients with and without heart
failure, chronic kidney disease, and/or diabetes. Am J Nephrol. 2017;46(3
Suppl):S1-S13. 5. LOKELMA® (sodium zirconium cyclosilicate) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. 6. Betts KA,
Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The cost of hyperkalemia in the United
States. Kidney Int Rep. 2018;3(2):385-393 2017;46(3):213-221.
doi:10.1016/j.ekir.2017.11.003 7. Epstein M, Reaven NL, Funk SE, McGaughey KJ,
Oestreicher N, Knispel J. Evaluation of the treatment gap between clinical
guidelines and the utilization of renin-angiotensin-aldosterone system
inhibitors. Am J Manag Care. 2015;21(11 suppl):S212-S220. 8. Kidney Disease:
Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical
Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney
Int. 2022;102(5S):S1-S127. doi:10.10 S220. 816/j.kint.2022.06.008 9. Kidney
Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020
Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease.
Kidney Int. 2020;98(4S):S1-S115. doi:10.1016/j.kint.2020.06.019 10. Kidney
Disease: Improving Global Outcomes. KDIGO 2021 Clinical Practice Guideline for
the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int.
2021;99(3S):S1-S87. doi:10.1016/j.kint.2020.11.003 11. Hollander-Rodriguez JC,
Calvert JF Jr. Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 12. Weisberg
LS. Management of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251.
doi:10.1097/CCM.0b013e31818f222b 13. Parham WA, Mehdirad AA, Biermann KM,
Fredman CS. Hyperkalemia revisited. Tex Heart Inst J. 2006;33(1):40-47. 14.
Palmer BF. Regulation of potassium homeostasis. Clin J Am Soc Nephrol.
2015;10(6):1050-1060. doi:102215/CJN.08580813 15. Mushiyakh Y, Dangaria H, Qavi
S, Ali N, Pannone J, Tompkins D. Treatment and pathogenesis of acute
hyperkalemia. J Community Hosp Intern Med Perspect.
2012;1(14):10.3402/jchimp.v1i4.732. doi:10.3402/jchimp.vi4.7372 16. Rafique Z,
Peacock F, Armstead T, et al. Hyperkalemia management in the emergency
department: An expert panel consensus. J Am Coll Emerg Physicians Open.
2021;2(5):e12572. doi:10.1002/emp2.12572

CKD=chronic kidney disease; DM=diabetes mellitus; HF=heart failure;
HTN=hypertension; K+=potassium; MOA=mechanism of action;
RAASi=renin-angiotensin-aldosterone system inhibitor.References: 1. Epstein M,
Reaven NL, Funk SE, et al. Evaluation of the treatment gap between clinical
guidelines and the utilization of renin-angiotensin-aldosterone system
inhibitors. Am J Manag Care. 2015;21:S212-S220. 2. Kidney Disease: Improving
Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice
Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int.
2020;98(4S):S1-S115. 3. Kidney Disease: Improving Global Outcomes. KDIGO 2021
Clinical Practice Guideline for the Management of Blood Pressure in Chronic
Kidney Disease. Kidney Int. 2021;99(3S):S1-S87. 4. Data on File, US-53732,
AZPLP.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; BP=blood pressure; CKD=chronic kidney disease; ED=emergency department;
GI=gastrointestinal; HbA1c=glycated hemoglobin; K+=potassium;
RAASi=renin-angiotensin-aldosterone system inhibitor; SPS=sodium polystyrene
sulfonate. Reference: 1. Data on File, US-53732, AZPLP.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; ARNI=angiotensin receptor-neprilysin inhibitor; HK=hyperkalemia; K+=
potassium; MRA=mineralocorticoid receptor antagonist; qod=every other day;
qd=once daily; RAASi=renin-angiotensin-aldosterone system; RWE=real-world
evidence; tid=three times daily; US=United States.References: 1. LOKELMA®
(sodium zirconium cyclosilicate) [prescribing information]. Wilmington, DE:
AstraZeneca Pharmaceuticals LP; 2022. 2. Kidney Disease: Improving Global
Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for
Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S):S1-S127.
doi:10.1016/j.kint.2022.06.008 3. Kidney Disease: Improving Global Outcomes
(KDIGO) Blood Pressure Work Group. KDIGO 2021 clinical practice guideline for
the management of blood pressure in chronic kidney disease. Kidney Int.
2021;99(3S):S1-S87. doi:101016/j.kint.2020.11.003 4. Heidenreich PA, Bozkurt B,
Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart
failure: a report of the American College of Cardiology/American Heart
Association Joint Committee on Clinical Practice Guidelines. Circulation.
2022;145(18):e895-e1032. 5. Spinowitz BS, Fishbane S, Pergola PE, et al. Sodium
zirconium cyclosilicate among individuals with hyperkalemia: a 12-month phase 3
study. Clin J Am Soc Nephrol. 2019;14(6):798-809. doi:10.2215/CJN.12651018 6.
Agiro A, Amin A, Cook EE, et al. Real-world modifications of
renin-angiotensin-aldosterone system inhibitors in patients with hyperkalemia
initiating sodium zirconium cyclosilicate therapy: the OPTIMIZE I study. Adv
Ther. 2023;40(6):2886–2901.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor
blocker; ARNI=angiotensin receptor-neprilysin inhibitor; CI=confidence interval;
CKD=chronic kidney disease; DM=diabetes mellitus; ECG=electrocardiogram;
ED=emergency department; eGFR=estimated glomerular filtration rate;
EHR=electronic health records; GI=gastrointestinal; HF=heart failure;
HK=hyperkalemia; IDN=integrated delivery network; K+= potassium; KDIGO=Kidney
Disease: Improving Global Outcomes; MI=myocardial infarction; MNT=medical
nutrition therapy; MRA=mineralocorticoid receptor antagonist; NA+=sodium;
RAASi=renin-angiotensin-aldosterone system inhibitor; RWE=real world evidence;
SD=standard deviation; SPS=sodium polystyrene sulfonate. References: 1. Collins
AJ, Pitt B, Reaven N, et al. Association of serum potassium with all-cause
mortality in patients with and without heart failure, chronic kidney disease,
and/or diabetes. Am J Nephrol. 2017;46(3):213-221. 2. LOKELMA® (sodium zirconium
cyclosilicate) [prescribing information]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; 2022. 3. Collins AJ, Pitt B, Reaven N, et al. Association of
serum potassium with all-cause mortality in patients with and without heart
failure, chronic kidney disease, and/or diabetes. Am J Nephrol. 2017;46(3
Suppl):S1-S13. 4. Epstein M, Reaven NL, Funk SE, et al. Evaluation of the
treatment gap between clinical guidelines and the utilization of
renin-angiotensin-aldosterone system inhibitors. Am J Manag Care. 2015;21(11
Suppl):S212-S220. 5. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes
Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in
Chronic Kidney Disease. Kidney Int. 2020;98(4S):S1-S115. 6. Kidney Disease:
Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical
Practice Guideline for the Management of Blood Pressure in Chronic Kidney
Disease. Kidney Int. 2021;99(3S):S1-S87. 7. Rowan CG, Agiro A, Chan A, et al.
Recurrence of hyperkalemia following dietary counseling: REVOLUTIONIZE I
real-world evidence study. Presented at: National Kidney Foundation (NFK) Spring
Clinical Meetings 2023; April 11-15, 2023. Poster 296. 8. Data on File,
REF-178557, AZPLP. 9. An J, Zhou H, Ni L, et al. Discontinuation of
renin-angiotensin-aldosterone system inhibitors secondary to hyperkalemia
translates into higher cardiorenal outcomes. Am J Nephrol. Published online May
18, 2023. doi:10.1159/000531102 10. Kidney Disease: Improving Global Outcomes
(KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes
Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S):S1-S127.
doi:10.1016/j.kint.2022.06.008 11. Hollander-Rodriguez JC and Calvert JF Jr.
Hyperkalemia. Am Fam Physician. 2006;73(2):283-290. 12. Weisberg LS. Management
of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251. 13. Parham WA,
Mehdirad AA, Biermann KM, et al. Hyperkalemia revisited. Tex Heart Inst J.
2006;33(1):40-47. 14. Dunn JD, Benton WW, Orozco-Torrentera E, et al. The burden
of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag
Care. 2015;21(15 Suppl):s307-s315. 15. Palmer BF. Regulation of potassium
homeostasis. Clin J Am Soc Nephrol. 2015;10:1050-1060. 16. Mushiyakh Y, Dangaria
H, Qavi S, et al. Treatment and pathogenesis of acute hyperkalemia. J Community
Hosp Intern Med Perspect. 2012;1(4):7372. doi:10.3402/jchimp.v1i4.7372 17.
Rafique Z, Peacock F, Armstead T, et al. Hyperkalemia management in the
emergency department: An expert panel consensus. J Am Coll Emerg Physicians
Open. 2021;2(5):e12572. doi:10.1002/emp2.12572


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