In a study of almost 1 million participants,

Hyperkalemia was an independent risk factor for all-cause mortality1

This figure depicts a spline regression analysis adjusted for covariates. The shaded areas of the curves indicate 95% confidence intervals.1

LOKELMA® (sodium zirconium cyclosilicate) is not indicated to reduce the risk of death.2

  • Serum K+ ≥5.0 mEq/L was associated with an increased risk of all-cause mortality in patients with HF, diabetes, CKD, all 3, or none of these comorbidities1
  • Even mild hyperkalemia (5.0-<5.5 mEq/L) was associated with increased all-cause mortality over an average 18-month follow-up1

Retrospective study of 911,698 patients from multiple integrated health delivery networks (Humedica). Control group included 338,297 individuals without known HF, CKD, diabetes, cardiovascular disease, or hypertension. Patient data came from private insurers, Medicare and Medicaid users, and uninsured individuals.1

Reducing or discontinuing RAAS inhibitor therapy to manage hyperkalemia may compromise guideline-recommended treatment3

Studies in heart failure and CKD patients underpin guidelines that uniformly recognize the importance of RAAS inhibitors for patients with diabetes, HF, and CKD4-6

HEART FAILURE CV RISK
(including CKD with or without diabetes)
CKD WITH DIABETES

CONSENSUS

CHARM

RALES

EMPHASIS-HF

SOLVD

HOPE

RENAAL

IDNT

  • The American Diabetes Association, KDIGO, and the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines/Heart Failure Society of America all recommend RAAS inhibitor therapy for patients with diabetes, CKD, and HF, respectively4-6

 

Despite guideline recommendations, RAAS inhibitor treatment was frequently reduced or discontinued to manage hyperkalemia.3

In 1 study, almost 50% of patients who experienced a moderate-to-severe hyperkalemia event* had their RAAS inhibitor stopped or reduced.3

In this analysis from the Humedica database of health records, medical data were analyzed for 66,862 patients with hyperkalemia. Patients with at least 1 outpatient RAAS inhibitor prescription were included in the 12-month analysis. Patients with end-stage renal disease, CKD stage 5, and acute kidney injury were excluded.3

*Moderate-to-severe hyperkalemia was defined as serum potassium ≥5.5 mEq/L.3

CKD=chronic kidney disease; CV=cardiovascular; HF=heart failure; KDIGO=Kidney Disease: Improving Global Outcomes; RAAS=renin-angiotensin-aldosterone system.

 

Choose LOKELMA in ANY setting for your adult patients with hyperkalemia2

LOKELMA does not replace temporizing agents for the emergency treatment of life-threatening hyperkalemia. With LOKELMA, there are no contraindications or drug interactions with temporizing agents listed in the Prescribing Information. LOKELMA can be used to treat hyperkalemia in adults in the emergency department, but should not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action.2

Learn about this innovative treatment option

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.

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.

DOSING

  • Non-hemodialysis Patients
    For initial treatment of hyperkalemia, the recommended starting dose is 10 g administered three times a day up to 48 hours. For maintenance treatment, the recommended starting dose is 10 g once daily. Monitor serum potassium and adjust dose of LOKELMA at 1-week intervals or longer in increments of 5 g based on serum potassium and desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily. Discontinue or decrease the dose of LOKELMA if serum potassium is below the desired target range.
  • Hemodialysis Patients
    For patients on chronic hemodialysis, administer LOKELMA only on non‑dialysis days. The recommended starting dose is 5 g once daily on non-dialysis days. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L. Monitor serum potassium and adjust the dose of LOKELMA based on the pre-dialysis serum potassium value after the long interdialytic interval and desired target range. During initiation and after dose adjustment, assess serum potassium after one week. Discontinue or decrease the dose of LOKELMA if serum potassium falls below the desired target range based on pre-dialysis value after the long interdialytic interval or the patient develops clinically significant hypokalemia. The recommended maintenance dose range is from 5 g to 15 g once daily, on non-dialysis days.

Please see full Prescribing Information for LOKELMA.

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.

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.

DOSING

  • Non-hemodialysis Patients
    For initial treatment of hyperkalemia, the recommended starting dose is 10 g administered three times a day up to 48 hours. For maintenance treatment, the recommended starting dose is 10 g once daily. Monitor serum potassium and adjust dose of LOKELMA at 1-week intervals or longer in increments of 5 g based on serum potassium and desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily. Discontinue or decrease the dose of LOKELMA if serum potassium is below the desired target range.
  • Hemodialysis Patients
    For patients on chronic hemodialysis, administer LOKELMA only on non‑dialysis days. The recommended starting dose is 5 g once daily on non-dialysis days. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L. Monitor serum potassium and adjust the dose of LOKELMA based on the pre-dialysis serum potassium value after the long interdialytic interval and desired target range. During initiation and after dose adjustment, assess serum potassium after one week. Discontinue or decrease the dose of LOKELMA if serum potassium falls below the desired target range based on pre-dialysis value after the long interdialytic interval or the patient develops clinically significant hypokalemia. The recommended maintenance dose range is from 5 g to 15 g once daily, on non-dialysis days.

Please see full Prescribing Information for LOKELMA.