What is the treatment regimen for hyperkalemia using Lokelma (sodium zirconium cyclosilicate)?

Lokelma (Sodium Zirconium Cyclosilicate) Treatment Regimen for Hyperkalemia

Initial Treatment Phase

For acute hyperkalemia management, administer Lokelma 10 g three times daily for up to 48 hours to achieve rapid potassium reduction. 1

• This dosing regimen consistently produces a mean serum potassium reduction of 1.1 mEq/L, typically lowering levels from 5.6 mEq/L to 4.5 mEq/L within 48 hours 2, 3
• Onset of action begins within 1 hour of the first dose, making it suitable for non-emergent hyperkalemia requiring rapid correction 2, 4
• 84% of patients achieve normokalemia (3.5-5.0 mEq/L) within 24 hours, and 98% within 48 hours 3
• The median time to potassium normalization is 2.2 hours 3

Critical limitation: Lokelma should not be used as emergency treatment for life-threatening hyperkalemia due to its delayed onset compared to acute interventions like insulin/glucose or calcium 1

Maintenance Treatment Phase

After achieving normokalemia, transition to Lokelma 10 g once daily for maintenance therapy. 1

• Maintenance doses of 5 g, 10 g, or 15 g once daily effectively maintain normal potassium levels for up to 28 days and beyond 2, 4
• In clinical trials, 90% of patients maintained normokalemia on 10 g daily dosing over 28 days 2
• Adjust the dose at one-week intervals by 5 g increments (up or down) based on serum potassium levels to maintain target range of 3.5-5.0 mEq/L 1

Dose-Response Relationship

The efficacy is clearly dose-dependent with exponential rates of potassium reduction 2:

• 5 g daily: Mean potassium 4.8 mEq/L during maintenance, 80% maintained normokalemia 3
• 10 g daily: Mean potassium 4.5 mEq/L during maintenance, 90% maintained normokalemia 3
• 15 g daily: Mean potassium 4.4 mEq/L during maintenance, 94% maintained normokalemia 3

Special Population: Chronic Hemodialysis

For patients on chronic hemodialysis, start with Lokelma 5 g once daily on non-dialysis days only. 1

• This lower starting dose reduces the risk of hypokalemia in dialysis patients 1
• Monitor closely for hypokalemia, which is a specific concern in this population 1

Administration Instructions

Administer Lokelma at least 2 hours before or 2 hours after other oral medications to avoid drug interactions. 1

• Lokelma works throughout the entire gastrointestinal tract (both small and large intestines), unlike other potassium binders that work primarily in the colon 2
• Mix the powder with water to create an oral suspension before administration 1

Monitoring Protocol

Check serum potassium levels within 24-48 hours after initiating therapy, then weekly during dose adjustments. 2, 4

• Regular monitoring is essential to avoid hypokalemia, particularly with higher maintenance doses 2, 4
• Once stable on maintenance therapy, continue monitoring at appropriate intervals based on clinical status and concurrent medications 2

Safety Profile and Adverse Effects

The most common adverse effect is mild to moderate edema, occurring in a dose-dependent manner 2, 4:

• 2% with placebo 3
• 2% with 5 g daily 3
• 6% with 10 g daily 2, 3
• 14% with 15 g daily 2, 3

Hypokalemia risk:

• Occurred in 10% of patients on 10 g daily and 11% on 15 g daily during clinical trials 3
• No hypokalemia occurred in the 5 g or placebo groups 3

Sodium content consideration: Each 5 g dose contains approximately 400 mg of sodium, requiring monitoring in patients who should restrict sodium intake or are prone to fluid overload 2

Critical Clinical Context

Do not discontinue RAAS inhibitors (ACE inhibitors, ARBs, aldosterone antagonists) when treating hyperkalemia with Lokelma. 2

• Lokelma enables optimization of cardioprotective RAAS inhibitor therapy while managing hyperkalemia 2
• The potassium-lowering efficacy of Lokelma is maintained regardless of concurrent RAAS inhibitor use 5
• This represents a major advantage over traditional management strategies that required down-titration or discontinuation of life-saving medications 6, 5

Comparison to Other Potassium Binders

Lokelma offers distinct advantages 2, 4:

• Faster onset: 1 hour vs. 7 hours for patiromer 2, 4
• Higher selectivity: More selective for potassium than sodium polystyrene sulfonate (SPS) 2
• Better safety profile: Unlike SPS, which has been associated with serious gastrointestinal adverse events 2
• Broader site of action: Works in both small and large intestines 2

Important Imaging Consideration

Lokelma has radio-opaque properties and may appear similar to an imaging agent on abdominal X-rays. 1

This should be considered when interpreting abdominal imaging studies in patients taking Lokelma 1.