Recommended dosing for initial treatment and maintenance therapy1

LOKELMA Initial Hyperkalemia Treatment LOKELMA Initial Hyperkalemia Treatment LOKELMA Maintenance Hyperkalemia Management LOKELMA Maintenance Hyperkalemia Management

  • Monitor serum K+ and adjust the dose of LOKELMA based on the serum K+ level and desired target range
  • For maintenance treatment, the recommended dosage is 10 g once daily
  • During maintenance treatment, the dose may be up-titrated based on the serum K+ level at intervals of 1 week or longer and in increments of 5 g
  • The dose of LOKELMA should be decreased or discontinued if serum K+ is below the desired target range
  • Recommended maintenance dosage range is 5 g every other day to 15 g daily

LOKELMA is tasteless and odorless2

LOKELMA Hyperkalemia Medication is TastelessLOKELMA Hyperkalemia Medication is Tasteless

  • LOKELMA is available as 5 g or 10 g white powder in a foil-lined packet for oral suspension1
  • Administer LOKELMA orally as a suspension in water1
  • Empty the entire contents of the packet(s) into a drinking glass containing approximately 3 tablespoons of water or more if desired1
  • Stir well and drink immediately1
  • If powder remains in the glass, add water, stir, and drink immediately. Repeat until no powder remains1

In general, other oral medications should be administered at least 2 hours before or 2 hours after taking LOKELMA1

  • Store LOKELMA between 59°F and 86°F1
  • LOKELMA does not need to be refrigerated1
  • No changes in potassium-lowering diet are required with LOKELMA. Advise your patients to adjust their dietary sodium, if appropriate1-3
  • LOKELMA can be taken with or without food1

39 drugs were tested to determine potential interactions with LOKELMA1

  • 16 drugs did not show an in vitro interaction with LOKELMA: allopurinol, apixaban, aspirin, captopril, cyclosporine, digoxin, ethinyl estradiol, lisinopril, magnesium, metformin, phenytoin, prednisone, propranolol, quinapril, spironolactone, ticagrelor
  • 9 of 23 drugs that showed an in vitro interaction were tested in vivo in healthy volunteers
    • Losartan, glipizide, and levothyroxine did not show any changes in exposure when co-administered with LOKELMA
    • There was an increase in systemic exposure to weak acids such as furosemide and atorvastatin when co-administered with LOKELMA
    • There was a decrease in systemic exposure to weak bases such as dabigatran when co-administered 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

Effects of LOKELMA on Pharmacokinetic ExposuresEffects of LOKELMA on Pharmacokinetic Exposures

CI=confidence interval.

IMPORTANT SAFETY INFORMATION FOR LOKELMA® (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

WARNINGS AND PRECAUTIONS:

  • Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid LOKELMA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders. LOKELMA has not been studied in patients with these conditions and it may be ineffective and may worsen gastrointestinal conditions
  • Edema: Each 5 g dose of LOKELMA contains approximately 400 mg of sodium. In clinical trials of LOKELMA, 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 the dose of diuretics as needed

ADVERSE REACTIONS: The most common adverse reaction with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of patients treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively vs 2.4% of patients receiving placebo.

DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.

INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Please see full Prescribing Information for LOKELMA.

IMPORTANT SAFETY INFORMATION FOR LOKELMA® (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

WARNINGS AND PRECAUTIONS:

  • Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid LOKELMA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders. LOKELMA has not been studied in patients with these conditions and it may be ineffective and may worsen gastrointestinal conditions
  • Edema: Each 5 g dose of LOKELMA contains approximately 400 mg of sodium. In clinical trials of LOKELMA, 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 the dose of diuretics as needed

ADVERSE REACTIONS: The most common adverse reaction with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of patients treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively vs 2.4% of patients receiving placebo.

DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.

INDICATION AND LIMITATION OF USE

LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Please see full Prescribing Information for LOKELMA.