What is the recommended dosage and treatment protocol for Lokelma (sodium zirconium cyclosilicate) in managing hyperkalemia?

Lokelma (Sodium Zirconium Cyclosilicate) Dosing Protocol for Hyperkalemia Management

For the treatment of hyperkalemia, Lokelma (sodium zirconium cyclosilicate) should be administered at an initial dose of 10 g three times daily for up to 48 hours, followed by a maintenance dose of 10 g once daily, with adjustments based on serum potassium monitoring. 1

Initial Treatment Phase

• Acute hyperkalemia correction:
  • Dose: 10 g three times daily for up to 48 hours 1
  • Administration: Mix entire contents of packet(s) in approximately 3 tablespoons of water, stir well and drink immediately 1
  • Onset of action: Significant reductions in serum potassium levels can be observed within 1 hour of a single 10 g dose 2
  • Efficacy: Can reduce serum potassium by approximately 0.7 mEq/L within 2 hours in emergency department patients with severe hyperkalemia (≥5.8 mEq/L) 2
  • Time to normalization: Median time to normalization is approximately 2.2 hours, with 84% of patients achieving normokalemia by 24 hours and 98% by 48 hours 3

Maintenance Phase

• Standard maintenance dosing:
  • Starting dose: 10 g once daily 1
  • Dose range: 5 g every other day to 15 g daily 1
  • Dose adjustments: Monitor serum potassium and adjust at intervals of 1 week or longer in increments of 5 g 1
  • Titration: Up-titrate based on serum potassium level; decrease dose or discontinue if serum potassium falls below desired target range 1

Special Population: Hemodialysis Patients

• For patients on chronic hemodialysis:
  • Administration timing: Only on non-dialysis days 1
  • Starting dose: 5 g once daily on non-dialysis days 1
  • For severe hyperkalemia (>6.5 mEq/L): Consider 10 g once daily on non-dialysis days 1
  • Maintenance dose range: 5-15 g once daily on non-dialysis days 1
  • Monitoring: Assess serum potassium after one week during initiation and after dose adjustments 1
  • Discontinuation criteria: If serum potassium falls below target range based on pre-dialysis value after long interdialytic interval, or if clinically significant hypokalemia develops 1

Administration Instructions

• Empty entire contents of packet(s) into a drinking glass containing approximately 3 tablespoons of water or more if desired 1
• Stir well and drink immediately 1
• If powder remains, add more water, stir and drink immediately; repeat until no powder remains 1
• Separate administration from other oral medications by at least 2 hours before or 2 hours after Lokelma 1

Monitoring Recommendations

• Recheck serum potassium within 2-4 hours after acute treatment 4
• Monitor serum potassium within 1 week of medication changes 4
• During maintenance therapy, monitor serum potassium regularly based on risk factors and comorbidities 4
• Watch for signs of hypokalemia, which can occur in 10-11% of patients on higher doses (10-15 g) 3
• Monitor for edema, particularly in patients who should restrict sodium intake or are prone to fluid overload 1

Clinical Efficacy

• In studies of chronic hyperkalemia, 3-times-daily SZC significantly reduced serum potassium concentrations within 48 hours 2
• Once-daily 5 g or 10 g SZC dose effectively maintained normokalemia over 14 to 28 days 2
• Long-term studies show efficacy maintained for up to 12 months 2, 5
• Effective across all patient subgroups including those with CKD, diabetes, heart failure, and those receiving RAAS inhibitor therapy 6

Potential Adverse Effects

• Most common adverse events: Hypokalemia and dose-dependent increase in edema 2
• Edema risk increases with higher doses (14% incidence with 15 g daily vs 2-6% with lower doses) 3
• Each 5 g dose contains approximately 400 mg of sodium 1
• No serious adverse events have been associated with SZC in randomized trials 2

Important Precautions

• Not for emergency treatment of life-threatening hyperkalemia due to delayed onset of action 1
• Avoid use in patients with severe constipation, bowel obstruction or impaction 1
• Use caution in patients who should restrict sodium intake or are prone to fluid overload 1
• Monitor for signs of edema, particularly with higher doses 1, 3
• SZC has been shown to be safe and effective in both adults and children with CKD stages 4-5 and those on dialysis 5, 7

Advantages Over Older Potassium Binders

• SZC has a more rapid onset of action (within 1 hour) compared to patiromer (approximately 7 hours) 2
• SZC has not been associated with serious adverse events in randomized trials, unlike sodium polystyrene sulfonate which has been linked to intestinal necrosis 2, 4
• SZC may provide an added benefit for patients with metabolic acidosis due to sustained increases in serum bicarbonate 2

By following this protocol, hyperkalemia can be effectively managed while minimizing risks of adverse effects and maintaining optimal potassium levels.