Lokelma Dosing in End-Stage Renal Disease (ESRD)
For patients with ESRD on chronic hemodialysis, start Lokelma at 5 g once daily on non-dialysis days only, with consideration for 10 g once daily if serum potassium exceeds 6.5 mEq/L. 1
Specific Dosing Algorithm for ESRD Patients
Initial Dosing
- Standard starting dose: 5 g once daily on non-dialysis days 1
- Higher starting dose: 10 g once daily on non-dialysis days if serum potassium >6.5 mEq/L 1
- Critical timing: Administer only on non-dialysis days 1
Dose Titration and Monitoring
- Monitor serum potassium based on pre-dialysis values after the long interdialytic interval 1
- Assess potassium levels one week after initiation and after each dose adjustment 1
- Maintenance dose range: 5-15 g once daily on non-dialysis days 1
- Titrate in 5 g increments at intervals of 1 week or longer based on pre-dialysis potassium values 1
When to Reduce or Discontinue
- Discontinue or decrease dose if serum potassium falls below target range based on pre-dialysis values after the long interdialytic interval 1
- Stop immediately if clinically significant hypokalemia develops 1
Clinical Evidence Supporting ESRD Dosing
The DIALIZE trial specifically evaluated Lokelma in hemodialysis patients and demonstrated robust efficacy with this dosing approach 2. In this phase 3b study of 196 ESRD patients on three-times-weekly hemodialysis, 41.2% of patients receiving Lokelma achieved the primary endpoint (maintaining pre-dialysis potassium 4.0-5.0 mmol/L during at least 3 of 4 treatments after the long interdialytic interval) compared to only 1.0% with placebo 2. Only 2.1% of Lokelma-treated patients required rescue therapy versus 5.1% on placebo 2.
Critical Safety Considerations in ESRD
Sodium and Fluid Management
- Sodium content: Each 5 g dose contains approximately 400 mg sodium 1
- Monitor for edema, particularly at doses ≥10 g daily, as edema incidence increases dose-dependently (2% at 5 g, 6% at 10 g, 14% at 15 g daily) 3
- Interdialytic weight gain was comparable between Lokelma and placebo groups in the DIALIZE trial 2
Hypokalemia Risk
- Low incidence: Few episodes of hypokalemia occurred in the DIALIZE trial 2
- Regular monitoring essential to avoid hypokalemia and guide dose adjustments 4
Drug Interactions
- Administer other oral medications at least 2 hours before or 2 hours after Lokelma, as it can bind medications throughout the GI tract and reduce their absorption 1
Important Caveats
Do not use Lokelma for life-threatening hyperkalemia due to delayed onset of action (begins at 1-2 hours); use insulin/glucose, beta-agonists, or dialysis first 4, 1. The standard acute dosing regimen (10 g three times daily for up to 48 hours) used in non-dialysis patients is not appropriate for ESRD patients on chronic hemodialysis 1.