LOKELMA

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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 [see Clinical Pharmacology (12.2) and Clinical Studies (14) ] . LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. ( 1 ) Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • Recommended starting dose is 10 g administered three times a day for up to 48 hours. ( 2.1 ) • For maintenance treatment, recommended dose is 10 g once daily. Adjust dose at one-week intervals as needed (by 5 g daily) to obtain desired serum potassium target range. ( 2.1 ) Patients on Chronic Hemodialysis • Recommended starting dose is 5 g once daily on non-dialysis days. ( 2.2 ) See full Prescribing Information for additional dosing instructions, as well as reconstitution and administration instructions for the oral suspension. 2.1 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 [see Dosage and Administration (2.3) ] . 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. 2.2 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. Monitor serum potassium and adjust the dose of LOKELMA based on the pre-dialysis serum potassium value after the long inter-dialytic interval and desired target range. During initiation and after a dose adjustment, assess serum potassium after one week. The recommended maintenance dose range is from 5 g to 15 g once daily, on non-dialysis days. Discontinue or decrease the dose of LOKELMA if: • serum potassium falls below the desired target range based on the pre-dialysis value after the long interdialytic interval, or; • the patient develops clinically significant hypokalemia 2.3 Reconstitution and Administration In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA [see Drug Interactions (7) ] . 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Gastrointestinal Adverse Events in Patients with Motility Disorders. ( 5.1 ) • Edema. ( 5.2 ) • Hypokalemia in patients on hemodialysis. ( 5.3 ) • LOKELMA has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.4 ) 5.1 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. 5.2 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 [see Adverse Reactions (6) ] . 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. 5.3 Hypokalemia in