LOKELMA was shown to be safe and generally well tolerated1

In Studies 1-3,

LOKELMA was shown to have a strong safety profile for patients not on dialysis1

Evaluation over the clinical trials
Evaluation over the clinical trials

Safety was evaluated in clinical trials with more than 1700 patients not on dialysis with hyperkalemia and comorbidities including CKD, DM, and CHF, with 507 patients treated for at least 1 year1

 

GI side effects
GI side effects

There are no GI side effects listed in the LOKELMA Prescribing Information; however, there were GI adverse events observed in the clinical studies1-5

 

94.1% of Patients
94.1% of Patients

on the 10 g qd recommended maintenance dose did not develop edema*1

 

95.9% of Patients
95.9% of Patients

did not develop hypokalemia1

Adverse events in patients not on dialysis

Edema

  • In clinical trials of LOKELMA, edema was generally mild to moderate in severity1
  • In placebo-controlled trials in which patients were treated with once-daily doses of LOKELMA for up to 28 days1:
Adverse Events in Non-Dialysis Patients
Adverse Events in Non-Dialysis Patients
  • 0.2% of patients (1/479) discontinued LOKELMA due to edema*6
  • In longer-term, uncontrolled trials, in which most patients were maintained on doses <15 g qd, edema (including edema, generalized edema, and peripheral edema) was reported in 8% to 11% of patients1

Hypokalemia

  • 4.1% of LOKELMA-treated patients developed hypokalemia with a serum K+ value of <3.5 mEq/L, which resolved with dose reduction or discontinuation of LOKELMA1

*During the maintenance phase, 1 patient who received 15 g LOKELMA qd was withdrawn due to general edema. There were no patient discontinuations due to edema for the initial phases of the trials.6

CHF=congestive heart failure; CKD=chronic kidney disease; DM=diabetes mellitus; GI=gastrointestinal; qd=once daily.

IN STUDY 4,

The safety of LOKELMA was comparable to placebo for patients on dialysis7

Overall, 40 patients in the LOKELMA group (41.7%) reported adverse events, compared to 46 patients in the placebo group (46.5%)1,7

Safety table
Safety table
  • In Study 4, in which most patients were treated with doses of 5 g 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 groups1

Hypokalemia

  • 5% of patients developed pre-dialysis hypokalemia (serum K+ <3.5 mEq/L) in both the LOKELMA and placebo groups; 3% and 1% of patients developed a serum K+ <3.0 mEq/L in the LOKELMA and placebo groups, respectively1

Other Adverse Events

  • The most common SAEs were angina pectoris (2.1%) in the LOKELMA group and hyperkalemia requiring rescue therapy (3%)* and fluid overload (2%) in the placebo group7

    – None of the SAEs were related to the study drug7

*Use of rescue therapy included but was not limited to insulin/glucose, sodium bicarbonate, β-adrenergic agonists, K+ binders (sodium polystyrene sulfonate, calcium polystyrene sulfonate, patiromer) and any other form of renal replacement therapy including additional dialysis or reduction in dialysate K+ concentration.7

GI=gastrointestinal; SAEs=serious adverse events.

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