In clinical trials of LOKELMA, edema was generally mild to moderate in severity.1

In placebo-controlled trials in which patients were treated with once-daily doses of LOKELMA for up to 28 days, edema was reported in1:

  • 4.4% of patients receiving LOKELMA 5 g
  • 5.9% of patients receiving LOKELMA 10 g
  • 16.1% of patients receiving LOKELMA 15 g
  • 2.4% of patients receiving placebo

In longer-term, uncontrolled trials, in which most patients were maintained on doses <15 g once daily1:

  • Edema (including edema, generalized edema and peripheral edema) was reported in 8% to 11% of patients1

In a pooled analysis of placebo-controlled trials in which patients were treated across all LOKELMA dose arms for up to 28 days2:

  • The discontinuation rate due to edema (including generalized edema, peripheral edema, fluid overload, and fluid retention) was 0.2% (1/479)2
  • During the maintenance phase, one patient who received 15 g LOKELMA once daily was withdrawn due to generalized edema. There were no patient discontinuations due to edema for the initial phase of the trials2

Hypokalemia

In clinical trials, 4.1% of LOKELMA-treated patients developed hypokalemia with a serum K+ value less than 3.5 mEq/L, which resolved with dosage reduction or discontinuation of LOKELMA.1

LOKELMA has been studied in clinical trials with more than 1700 patients1

LOKELMA safetyLOKELMA safetyLOKELMA safetyLOKELMA safety

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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.