Sodium Zirconium Cyclosilicate (Lokelma)


Indications

Hyperkalemia (see Hyperkalemia)

Clinical Efficacy

  • Multicenter, Double-Blind, Phase 3 Trial of Sodium Zirconium Cyclosilicate in the Treatment of Hyperkalemia (NEJM, 2015) [MEDLINE]
    • As Compared to Hyperkalemic Patients Who Received Placebo, Patients Who Received Sodium Zirconium Cyclosilicate Had a Significant Reduction in Serum Potassium levels at 48 hrs, with Normokalemia Maintained During 12 Days of Maintenance Therapy
  • Phase II, Randomized, Double-Blind, Placebo-Controlled Study (ENERGIZE) (Acad Emerg Med, 2020) [MEDLINE]
    • Sodium Zirconium Cyclosilicate with Insulin and Glucose May Provide an Incremental Benefit in the Emergency Treatment of Hyperkalemia Over Insulin and Glucose Alone

Contraindications


Pharmacology

Potassium Binder Which Preferentially Exchanges Potassium for Hydrogen and Sodium, Decreasing the Potassium Concentration in the Gastrointestinal Lumen

  • Decreases Serum Potassium Levels
  • Onset of Action: 1 hr

Sodium Content

  • Each 5 g Dose Contains Approximately 400 mg of Sodium

Metabolism

  • None Known

Excretion

  • Excreted in Stool

Cost

  • Cost is Approximately $28.33 Per Each 5 g Pack

Administration

Oral (PO)

  • Start: 10 g TID for up to 48 hrs
  • Adjustment: adjust dose by 5 g qday at 1 week intervals (based on serum potassium values)
  • Maintenance: 5-15 g qday

Dose Adjustment

  • Hepatic: no specific dosage adjustment per the manufacturer’s labeling
  • Renal
    • Mild-Severe Renal Impairment: no specific dosage adjustment per the manufacturer’s labeling
    • Intermittent Hemodialysis (3x Per Week)
      • Initial: 5g qday on non-dialysis days (maximum dose: 10 g qday may be considered in patients with serum potassium >6.5 mEq/L)
      • Adjustment: adjust dose at 1 week intervals (based on predialysis serum potassium measured after the long interdialytic interval and the desired target range)
      • Maintenance: 5-15g daily on non-dialysis days

Use in Pregnancy (see Pregnancy)

  • Sodium Zirconium Cyclosilicate is Not Systemically Absorbed (and Exposure to the Fetus Would Not Be Expected

Use During Lactation

  • Sodium Zirconium Cyclosilicate is Not Systemically Absorbed (and Distribution into Breast Mild Would Not Be Expected

Drug Interactions

  • Clopidogrel (Plavix) (see Clopidogrel): sodium zirconium cyclosilicate may decrease serum concentrations of the active metabolites of clopidogrel
  • Coumadin (see Coumadin): sodium zirconium cyclosilicate may increase the serum concentration of coumadin
  • Dabigatran Etexilate (Pradaxa) (see Dabigatran): sodium zirconium cyclosilicate may decrease the serum concentration of dabigatran etexilate

Adverse Effects

Gastrointestinal Adverse Effects

Renal Adverse Effects

  • Hypokalemia (see Hypokalemia)
    • Epidemiology
      • Occurs in 3-4% of Cases

Rheumatologic/Orthopedic Adverse Effects

  • Peripheral Edema (see Peripheral Edema)
    • Epidemiology
      • Occurs in 4-16% of Cases
      • Peripheral Edema is More Common in Patients Who are Not on Dialysis or in Those Treated with Higher Doses

References