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Prescribing Information LOKELMA® (sodium zirconium cyclosilicate)
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LOKELMA® (sodium zirconium cyclosilicate) is indicated for the treatment of hyperkalaemia in adult patients.

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  • Dosing and administration | LOKELMA (sodium zirconium cyclosilicate) | AstraZeneca UK
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Dosing and administration | LOKELMA (sodium zirconium cyclosilicate) | AstraZeneca UK

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LOKELMA®

(sodium zirconium cyclosilicate):

Dosing and administration

  • Dosing
  • Administration

LOKELMA® (sodium zirconium cyclosilicate) dosing and administration for hyperkalaemia

LOKELMA is a powder for oral suspension, available in 5g or 10g doses. The dosing of LOKELMA varies for hyperkalaemia patients depending on their dialysis status. LOKELMA’s dosing regimen has been established based on findings from relevant clinical trials.

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How is LOKELMA administered?

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LOKELMA is administered orally after resuspending in water the contents of the sachet and it is tasteless.
Administration of LOKELMA  should be at least 2 hours before or 2 hours after tacrolimus or oral medications with clinically meaningful pH-dependent bioavailability.† LOKELMA can be taken without spacing of dosing times with oral medications that do not exhibit pH-dependent bioavailability.1,2


LOKELMA has no special conditions for storage.1

†This includes azole antifungals (ketoconazole, itraconazole and posaconazole), anti-HIV drugs (atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir and rilpivirine), tyrosine kinase inhibitors (erlotinib, dasatinib and nilotinib) and immunosuppressants (tacrolimus).

LOKELMA mixing instructions

The LOKELMA dose should be mixed with around 3 tablespoons or 45 mL of water.
Patients should adhere to the following steps:1

 

  • Stir the contents well
  • Drink the suspension straight away while still cloudy
  • Re-stir if the powder settles
  • Drink all of the contents

Can LOKELMA be taken with food

LOKELMA may be taken with or without food.1,2

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LOKELMA correction phase

The recommended starting dose of LOKELMA is 10g, taken three times a day orally as a suspension in water until normokalaemia is achieved.1,2

 

If normokalaemia is not attained within 48 hours of initiating treatment, the same regimen can be extended for an additional 24 hours. If normokalaemia is not achieved after 72 hours of treatment, alternative treatment approaches should be considered.1,2

LOKELMA maintenance dose

Once normokalemia has been achieved, it is important to determine the minimal effective dose of LOKELMA to prevent the recurrence of hyperkalaemia. The following maintenance regimen is recommended:1,2

 

  • A LOKELMA starting dose of 5g once daily
  • The dose may be titrated up to 10g once daily, or down to 5g every other day
  • No more than 10g once daily should be used for maintenance therapy

LOKELMA dosing guidance based on dosing schedule for maintenance therapy from ZS-005*3

Adapted from Spinowitz et al. 2019.


This guidance is not prescriptive or intended to replace clinical judgement.  In an emergency situation, standard of care should be used in line with local or national hyperkalaemia management guidelines.

table table

Adapted from Spinowitz et al. 2019. 


* Study ZS-005 was a 12-month, multicentre, open-label, single-arm, phase 3 trial evaluating the long-term safety and efficacy of LOKELMA in patients with hyperkalaemia. In the correction phase, adult patients (n=751) with serum potassium levels of ⪰ 5 mmol/L received LOKELMA 10g three times daily for 24-72 hours until normokalaemic (3.5-5.0 mmol/L). Patients (n=746) who achieved normokalaemia entered the subsequent 12-month maintenance phase and received 5g of LOKELMA once daily titrated to maintain normokalaemia without dietary or medication restrictions. Prespecified primary end points were restoration of normal serum potassium values (3.5-5.0 mmol/L) during the correction phase and maintenance of serum potassium ⪰5.1 mmol/L during maintenance phase. Adverse events were assessed throughout.3

Patients who miss a dose of LOKELMA should be instructed to take the next usual dose at their normal time.1,2

LOKELMA safety information

Monitoring potassium levels during the administration of LOKELMA

Serum potassium levels should be monitored regularly during hyperkalaemia treatment, and monitoring frequency can depend on several factors, including:1,2

  • Other medications
  • Progression of CKD
  • Dietary potassium intake

 

In the event of severe hypokalaemia, LOKELMA administration should be discontinued and the patient should be re-evaluated.1,2

LOKELMA dosing should exclusively occur on non-dialysis days.1,2

 

The recommended LOKELMA starting dose is 5g once daily. To establish normokalaemia (4.0–5.0 mmol/L), this dose may be titrated up or down weekly based on the pre-dialysis serum potassium value after the long interdialytic interval.1,2

 

Dose adjustments should be done at intervals of 1 week in increments of 5g up to 15g once daily on non-dialysis days.1,2

Monitoring potassium levels during the administration of LOKELMA for patients on haemodialysis

It is recommended to monitor serum potassium weekly while the LOKELMA dosage is adjusted. Once normokalaemia is established, potassium should be monitored regularly (e.g. monthly, or more frequently based on clinical judgement including changes in dietary potassium or medication affecting serum potassium).1,2

If a dose of LOKELMA is missed, advise patients to resume their regular dosing schedule with the next dose.


An overdose of LOKELMA (sodium zirconium cyclosilicate) may result in hypokalaemia. Serum potassium levels should be monitored and potassium supplemented as needed.1,2

Special populations and LOKELMA dosing

There are no data from the use of LOKELMA in pregnant women. Therefore, as a precautionary measure, it is advisable to avoid the use of LOKELMA during pregnancy.1,2


In a postnatal study in rats, maternal exposure to LOKELMA had no effect on postnatal development. Due to its physicochemical properties, LOKELMA is not systemically absorbed and is not expected to be excreted in breast milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to LOKELMA is negligible. LOKELMA can be used during breast-feeding.1,2


There are no specific dosage or administration guidelines recommended for the elderly population.1,2


The safety and efficacy of LOKELMA in children and adolescents under 18 years of age have not been established.1,2

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All Resources

 

Explore informative videos and guides to help you understand more about LOKELMA and support your patients

 

 

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LOKELMA dosing and administration card

 

This resource clarifies the dosing and administration information for LOKELMA

 

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Patient resource: Guide to LOKELMA for hyperkalaemia

A quick guide that introduces your patients to LOKELMA and helps them to better understand hyperkalaemia

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AD, alternate days; CKD, chronic kidney disease; OD, once daily.

 

  1. LOKELMA (sodium zirconium cyclosilicate) Summary of Product Characteristics.
  2. Spinowitz BS, et al, Clin J Am Soc Nephrol. 2019 Jun 7;14(6):798-809

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