sodium zirconium cyclosilicate (Rx)

Brand and Other Names:Lokelma
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for oral suspension

  • 5g/packet
  • 10g/packet

Hyperkalemia

Indicated for hyperkalemia

Initial: 10 g PO TID for up to 48 hr

Maintenance

  • 10 g PO qDay
  • May titrate based on serum potassium level and desired target range at intervals of 1 week or longer and in increments of 5 g
  • Dosing may range from 5 g every other day to 15 g qDay); not to exceed 15 g/day

Dosing Considerations

Not to be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action

Monitor serum potassium and adjust dose based on the serum potassium level and desired target range

The dose should be decreased or discontinued if serum potassium is below desired target range

Safety and efficacy not been established

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Adverse Effects

>10%

Edema (4.4-16.1%)

1-10%

Hypokalemia (4.1%)

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Warnings

Contraindications

None

Cautions

Avoid with severe constipation or bowel obstruction or impaction, including abnormal postoperative bowel motility disorders; safety and efficacy not studied in these patients and may be ineffective and may worsen GI conditions

Each 5-g dose of sodium zirconium cyclosilicate contains ~400 mg of sodium; in clinical trials, mild-to-moderate edema was more commonly seen in patients treated with 15 g qDay; monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure, renal disease); increase diuretic dose as needed

Edema

  • Each 5 g dose contains approximately 400 mg of sodium; in clinical trials, edema was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily
  • Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure or renal disease)
  • Advise patients to adjust dietary sodium, if appropriate; increase dose of diuretics as needed

Drug interactions overview

  • Transient changes of gastric pH
    • Sodium zirconium cyclosilicate transiently increases gastric pH, which can change the absorption of coadministered drugs that exhibit pH-dependent solubility, potentially leading to altered efficacy or safety of these drugs when coadministered
    • In general, other oral medications whose solubility is pH-dependent should be administered at least 2 hr before or after sodium zirconium cyclosilicate
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Pregnancy

Pregnancy

Not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug

Lactation

Not absorbed systemically following oral administration, and breastfeeding is not expected to result in exposure to the child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Potassium binder; nonabsorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium

It increases fecal potassium excretion through binding of potassium in the lumen of the GI tract; binding of potassium reduces the free potassium concentration in the GI lumen, thereby lowering serum potassium level

Absorption

In a clinical study in patients with hyperkalemia in which zirconium concentrations were measured in the urine and blood, zirconium concentrations were similar in treated and untreated patients

Excretion

A vivo mass balance study in rats showed the drug was recovered in the feces with no evidence of systemic absorption

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Administration

Oral Administration

Empty the entire contents of the packet(s) into a drinking glass containing ~3 tablespoons of water or more if desired

Stir well and drink immediately

If powder still remains in the drinking glass, add water, stir, and drink immediately; repeat until no powder remains to ensure the entire dose is taken

Storage

Packets: Store at 15-30°C (59-86°F)

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.