Lokelma Drug Information
Generic name: SODIUM ZIRCONIUM CYCLOSILICATE
Uses of Lokelma
LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Dosage & Administration of Lokelma
Recommended Dosage
For initial treatment of hyperkalemia, the recommended dose of LOKELMA is 10 g administered three times a day for up to 48 hours. Administer LOKELMA orally as a suspension in water. For continued treatment, the recommended dose is 10 g once daily.
Monitor serum potassium and adjust the dose of LOKELMA based on the serum potassium level and desired target range. During maintenance treatment, up-titrate based on the serum potassium level at intervals of 1-week or longer and in increments of 5 g. Decrease the dose of LOKELMA or discontinue if the serum potassium is below the desired target range.
The recommended maintenance dose range is from 5 g every other day to 15 g daily.
Dosage Adjustment for Patients on Chronic Hemodialysis
For patients on chronic hemodialysis, administer LOKELMA only on non-dialysis days. The recommended starting dose is 5 g once daily on non-dialysis days. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L.
During initiation and after a dose adjustment, assess serum potassium after one week.
Reconstitution and Administration
In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA. Instruct patients to empty the entire contents of the packet(s) into a drinking glass containing approximately 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.
Side Effects of Lokelma
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The total exposure to LOKELMA in the safety and efficacy clinical trials of patients not on dialysis with hyperkalemia was 1,760 patients with 652 patients exposed to LOKELMA for at least 6 months and 507 patients exposed for at least one year. The population (n=1,009) in the placebo-controlled trials included patients aged 22 to 96 years, females (n=454), Caucasians (n=859) and Blacks (n=130).
Patients had hyperkalemia in association with comorbid diseases such as chronic kidney disease, heart failure, and diabetes mellitus. In longer-term uncontrolled trials in which most patients were maintained on doses <15 g once daily, adverse reactions of edema (edema, generalized edema and peripheral edema) were reported in 8% to 11% of patients. Laboratory Abnormalities In clinical trials in patients who were not on dialysis, 4.1% of LOKELMA-treated patients developed hypokalemia with a serum potassium value less than 3.5 mEq/L, which resolved with dosage reduction or discontinuation of LOKELMA.
In a clinical trial of LOKELMA in patients on chronic hemodialysis, 5% of patients developed pre-dialysis hypokalemia (serum potassium <3.5 mEq/L) in both the LOKELMA and placebo groups; 3% and 1% of patients developed a serum potassium < 3.0 mEq/L in the LOKELMA and placebo groups, respectively.
Warnings & Cautions for Lokelma
Gastrointestinal Adverse Events in Patients with Motility Disorders Avoid use of Lokelma in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Lokelma has not been studied in patients with these conditions and may be ineffective and may worsen gastrointestinal conditions.
Edema Each 5 g dose of Lokelma contains approximately 400 mg of sodium, but the extent of absorption by the patient is unknown. In clinical trials of Lokelma in patients who were not on dialysis, edema was observed and 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 (e.g., heart failure or renal disease).
Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed. In a clinical trial of Lokelma in patients on chronic hemodialysis in which most patients were treated with doses of 5 to 10 g once daily on non-dialysis days, there was no difference in the mean change from baseline in interdialytic weight gain (a measure of fluid retention) between the Lokelma and placebo groups.
Hypokalemia in Patients on Hemodialysis Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia on Lokelma (e.g., illnesses associated with decreased oral intake, diarrhea). Consider adjusting Lokelma dose based on potassium levels in these settings.
Diagnostic Tests Lokelma has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures.
Drug Interactions with Lokelma
LOKELMA can transiently increase gastric pH. As a result, LOKELMA can change the absorption of co-administered drugs that exhibit pH-dependent solubility, potentially leading to altered efficacy or safety of these drugs when taken close to the time LOKELMA is administered. In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA.
LOKELMA is not expected to impact systemic exposure of drugs that do not exhibit pH-dependent solubility and so spacing is not needed if it has been determined that the concomitant medication does not exhibit pH-dependent solubility.
Pregnancy Safety for Lokelma
Pregnancy Risk Summary LOKELMA is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.
Pediatric Use of Lokelma
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Clinical Studies of Lokelma
Eleven-Month Extension Study Patients who completed the 28-day randomized withdrawal phase had the option to continue treatment with LOKELMA, taken just before breakfast, in an open-label extension phase for up to 11 months (n=123; NCT02107092). Figure 4 shows that the treatment effect on serum potassium was maintained during continued therapy. The mean baseline potassium level in this study was 5.6 mEq/L.
For maintenance treatment, the initial dosage of LOKELMA was 5 g once daily and was adjusted to a minimum of 5 g every other day up to maximum of 15 g once daily, based on serum potassium level.
Study 4
The effectiveness of LOKELMA in lowering serum potassium was studied in a double-blind, placebo-controlled trial of 196 chronic hemodialysis patients (mean age 58 years, range 20 to 86 years) with persistent pre-dialysis hyperkalemia (mean baseline potassium 5.8 mEq/L) who were randomized to receive LOKELMA 5 g or placebo once daily on non-dialysis days (NCT03303521). During the dose adjustment period (initial 4 weeks), the dose was adjusted weekly in 5 g increments up to 15 g once daily based on pre-dialysis serum potassium measurement after the long inter-dialytic interval to achieve a pre-dialysis serum potassium level between 4.0-5.0 mEq/L. The dose reached at the end of the dose-adjustment period was maintained throughout the subsequent 4-week evaluation period.
The primary endpoint in the trial was the proportion of responders, defined as patients who maintained a pre-dialysis serum potassium between 4.0 and 5.0 mEq/L on at least 3 out of 4 dialysis treatments after the long inter-dialytic interval and who did not receive rescue therapy during the evaluation period. A greater proportion of patients were responders in the LOKELMA arm as compared to placebo (41% vs 1%, respectively; p<0.001). The treatment effect on mean pre-dialysis serum potassium levels was maintained during continued treatment.
Mean pre-dialysis serum potassium levels during the study are presented in Figure 5. Figure 5: Mean Pre-Dialysis Serum Potassium Levels Over Time in Patients on Chronic Hemodialysis F/U - follow-up period The displayed error bars correspond to 95% confidence intervals. n = Number of patients with non-missing potassium measurements at a particular visit. figure_5
| Mean Serum Potassium Change mEq/L (95% Confidence Intervals) Sample Size | Placebo | 1.25 g TID | 2.5 g TID | 5 g TID | 10 g TID |
|---|---|---|---|---|---|
| All Patients | -0.2 (-0.3, -0.2) n=158 | -0.3 (-0.4, -0.2) n=150 | -0.5 (-0.5, -0.4) n=137 | -0.5 (-0.6, -0.5) n=152 | -0.7 (-0.8, -0.7) n=140 |
| Baseline Serum Potassium >5.5 mEq/L | -0.4 (-0.6, -0.3) n=40 | -0.3 (-0.5, -0.2) n=40 | -0.6 (-0.7, -0.4) n=37 | -0.9 (-1.0, -0.7) n=29 | -1.1 (-1.3, -0.9) n=22 |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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