In one study, LOKELMA rapidly reduced serum potassium levels and started to work in as early as 1 hour1,2

Serum Potassium Levels After 48 Hours ChartSerum Potassium Levels After 48 Hours Chart

The study met its primary endpoint (difference in the exponential rate of change in serum K+ levels during the initial 48 hours of LOKELMA vs placebo), demonstrating a greater rate of reduction in serum K+ levels for patients receiving LOKELMA compared to placebo (P<0.001).2

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

With initial treatment, LOKELMA 10 g three times a day for 48 hours1,2:

  • Reductions in serum K+ levels were observed in as early as 1 hour after initiation of therapy2
  • Levels continued to decline over the 48-hour treatment period2
  • The study met its primary endpoint, demonstrating a greater reduction in serum K+ levels over 48 hours for patients receiving LOKELMA compared to placebo (P<0.001)1,2
  • Patients with higher starting potassium levels had a greater response to LOKELMA2

RAPID REDUCTION

Reductions in serum K+ levels were observed in as early as 1 hour after initiation of therapy1

EFFICACY IN SUBGROUPS

LOKELMA was effective in lowering potassium levels in patients with CKD, heart failure, diabetes, and those taking RAAS inhibitor therapy2

 

CKD=chronic kidney disease; RAAS=renin-angiotensin-aldosterone system.

Study 1 Design

  • In the initial phase of a multicenter, 2-part, double-blind, randomized, placebo-controlled, phase 3 trial, 753 patients received placebo or 1.25 g, 2.5 g, 5 g, or 10 g LOKELMA 3 times daily with meals for the initial 48 hours1,2
  • For initial treatment, the recommended dose of LOKELMA is 10 g administered 3 times a day for up to 48 hours2

Sample Demographics from Study 1

Across all studies, 42% of patients were younger than 65 years old2

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

In another study, LOKELMA achieved and sustained normokalemia* for up to 1 year2

Tab

Normal Serum Potassium Levels within 48 Hours Chart Normal Serum Potassium Levels within 48 Hours Chart

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Serum Potassium Range Chart Serum Potassium Range Chart

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Serum Potassium with Continued Treatment LOKELMA Chart Serum Potassium with Continued Treatment LOKELMA Chart

The study met its primary endpoint (mean serum potassium value over days 8-29), with LOKELMA 5 g, 10 g, and 15 g maintaining lower mean serum K+ levels than placebo (4.8 mEq/L, 4.5 mEq/L, 4.4 mEq/L, vs 5.1 mEq/L, respectively).2

In the initial 48-hour open-label phase, 92% of patients achieved normal serum K+ levels within 48 hours from baseline2

  • Average serum K+ levels decreased from 5.6 mEq/L to 4.5 mEq/L (in the initial open-label phase with LOKELMA 10 g three times a day for 48 hours with meals)2
  • LOKELMA maintained serum K+ for 11 months with continued therapy in patients who completed the 28-day randomized withdrawal phase2
  • The recommended maintenance 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 level and desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily2
  • LOKELMA was administered in clinical trials without the requirement of low-potassium–diet modifications1,3

Study 2 Design

  • After the open-label initial phase of a multicenter, 2-part, phase 3 trial, in which 258 patients received 10 g LOKELMA administered 3 times daily with meals for 48 hours, patients who achieved a K+ level between 3.5 mEq/L and 5.0 mEq/L were randomized (4:4:4:7) to receive 5 g, 10 g, or 15 g LOKELMA or placebo once daily taken just before breakfast for 28 days in the withdrawal phase2,3
  • 123 patients who completed the 28-day randomized withdrawal phase had the option to continue treatment with LOKELMA, taken just before breakfast, in an open-label extension phase for up to 11 months. Patients who had serum K+ values between 3.5 and 5.5 mEq/L at day 29 started on open-label LOKELMA at 10 g once daily. Patients with serum K+ values >5.5 mEq/L at day 29 received LOKELMA 10 g tid for up to 48 hours, and those who achieved normokalemia* entered into the open-label extended dosing phase and received LOKELMA at 10 g once daily. Patients had their K+ level monitored periodically during the study and the dose of LOKELMA was titrated in 5 g increments to 5 g every other day up to 15 g once daily, based on K+ values2,4

*Normokalemia was defined as serum potassium levels between 3.5 and 5 mEq/L.3

The randomized withdrawal phase was defined by patients on LOKELMA randomized to placebo 5 g, 10 g, 15 g and then withdrawn.

CKD=chronic kidney disease; RAAS=renin-angiotensin-aldosterone system; tid=3 times a day.

IMPORTANT SAFETY INFORMATION FOR LOKELMA® (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

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. In clinical trials of LOKELMA, edema 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

ADVERSE REACTIONS: The most common adverse reaction 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 patients treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively vs 2.4% of 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 see full Prescribing Information for LOKELMA.

IMPORTANT SAFETY INFORMATION FOR LOKELMA® (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

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. In clinical trials of LOKELMA, edema 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

ADVERSE REACTIONS: The most common adverse reaction 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 patients treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively vs 2.4% of 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 see full Prescribing Information for LOKELMA.