LOKELMA

Antidotes, Adsorbents
Mineral Binding Agents

In general, administer other oral medications at least 2 hours before or 2 hours after sodium zirconium cyclosilicate. Transient increases in gastric pH around the time of sodium zirconium cyclosilicate administration may alter the absorption of medications that exhibit pH-dependent solubility. Altering the absorption of medications that are simultaneously coadministered with sodium zirconium cyclosilicate may reduce their efficacy or increase the risk for adverse effects.

Powder for oral suspension
Empty the entire contents of the packet(s) into a drinking glass containing about 3 tablespoons of water or more, if desired.
Stir well and drink immediately.
If powder remains in the drinking glass, add water, stir, and drink immediately. Repeat until no powder remains to ensure the entire dose is taken.

edema / Delayed / 4.4-16.1
hypokalemia / Delayed / 3.0-5.0
peripheral edema / Delayed / Incidence not known

LOKELMA

Rx

Oral potassium binder
Used for treatment of hyperkalemia in adults, including patients with end-stage renal disease receiving chronic hemodialysis
Dose separation from other oral drugs necessary

10 g PO 3 times daily for up to 48 hours, initially, then 10 g PO once daily. Monitor serum potassium and adjust the dosage based on desired target range. Increase the dosage in increments of 5 g at intervals of 1 week or longer to achieve desired target, and decrease the dosage or discontinue therapy if serum potassium is below the desired target. The recommended maintenance dosage range is 5 g every other day to 15 g once daily.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Chronic hemodialysis
The recommended initial dose is 5 g PO once daily on non-dialysis days; consider a starting dose of 10 g PO once daily on non-dialysis days in patients with serum potassium more than 6.5 mEq/L. Monitor serum potassium and adjust the dose of sodium zirconium cyclosilicate based on the pre-dialysis serum potassium concentration after the long inter-dialytic interval and desired target range. During initiation and after a dose adjustment, assess serum potassium after 1 week. The recommended maintenance dose is 5 to 15 g PO once daily on non-dialysis days. Discontinue or decrease the dose if serum potassium falls below the desired target range or the patient develops clinically significant hypokalemia.[63166]

In general, administer oral medications at least 2 hours before or 2 hours after sodium zirconium cyclosilicate. Transient increases in gastric pH at the time of administration may alter medication absorption and reduce efficacy or increase toxicity.

LOKELMA/Sodium zirconium cyclosilicate Oral Pwd F/Recon: 5g, 10g

30 g/day PO.

30 g/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Sodium zirconium cyclosilicate is a potassium binder with a high affinity for potassium ions. It is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium, even in the presence of other cations such as calcium or magnesium. Sodium zirconium cyclosilicate increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen resulting in lower serum potassium concentrations.

Sodium zirconium cyclosilicate is administered orally. Sodium zirconium cyclosilicate is insoluble and does not undergo enzymatic metabolism. It is recovered in the feces with no evidence of systemic absorption.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

In healthy subjects, sodium zirconium cyclosilicate 5 or 10 g once daily for 4 days caused a dose-dependent increase in fecal potassium excretion and corresponding dose-dependent decreases in urinary potassium excretion and serum potassium concentrations. In hyperkalemic patients treated with sodium zirconium cyclosilicate 10 g PO 3 times daily for 48 hours, reductions in serum potassium were observed 1 hour after initiation of therapy and continued to decline over 48 hours. Patients with higher starting serum potassium concentrations or receiving a higher dose experienced greater reductions in serum potassium. In patients not continuing sodium zirconium cyclosilicate, potassium concentrations increased. Zirconium concentrations in urine and blood were similar (i.e., either undetectable or around the lower limit of quantification) in treated and untreated patients.

Sodium zirconium cyclosilicate is not systemically absorbed after oral administration, and maternal use during pregnancy is not expected to result in fetal exposure to the drug.

Sodium zirconium cyclosilicate is not systemically absorbed after oral administration, and breast-feeding is not expected to result in exposure of the child to the drug.