Lokelma

Hyperkalemia
Treatment
4 Active Studies for Lokelma

What is Lokelma

Sodium zirconium cyclosilicateThe Generic name of this drug
Treatment SummaryLokelma is a medication used to reduce potassium levels in the blood. It is a powder that is mixed with water and taken orally, and has no taste or smell. Studies have shown that it starts working within 1 hour and usually gets potassium levels back to normal within 2.2 hours, with 92% of patients reaching normal levels within 48 hours. The effects can last for up to 12 months.
Lokelmais the brand name
image of different drug pills on a surface
Lokelma Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Lokelma
Sodium zirconium cyclosilicate
2018
2

Effectiveness

How Lokelma Affects PatientsSodium zirconium cyclosilicate is a drug that helps lower potassium levels in the blood. It usually takes 1-2 days for the drug to take effect. It does not affect calcium, magnesium, or sodium levels. Taking the drug causes less potassium to be released in urine and more to be released in feces. It also increases the amount of bicarbonate and reduces the amount of aldosterone in the body. There have also been changes in blood urea nitrogen levels, but no changes in blood pressure.
How Lokelma works in the bodyHyperkalemia is a condition where there are too many potassium ions in the blood. It is common in people with kidney or heart failure. Sodium zirconium cyclosilicate works by trapping potassium ions in the stomach and intestines and then releasing them in the feces. This decreases the amount of free potassium in the body and helps lower high potassium levels in the blood.

When to interrupt dosage

The recommended dosage of Lokelma is contingent upon the identified affliction. The measure will differ as per the administration approach featured in the table beneath.
Condition
Dosage
Administration
Hyperkalemia
1.0 mg/mg, 5.0 mg/mg, , 10000.0 mg, 5000.0 mg
Powder, for suspension - Oral, Powder, for suspension, , Oral

Warnings

There are 20 known major drug interactions with Lokelma.
Common Lokelma Drug Interactions
Drug Name
Risk Level
Description
Atazanavir
Major
Sodium zirconium cyclosilicate can cause a decrease in the absorption of Atazanavir resulting in a reduced serum concentration and potentially a decrease in efficacy.
Infigratinib
Major
The serum concentration of Infigratinib can be decreased when it is combined with Sodium zirconium cyclosilicate.
Methenamine
Major
The therapeutic efficacy of Methenamine can be decreased when used in combination with Sodium zirconium cyclosilicate.
Bisacodyl
Minor
The therapeutic efficacy of Bisacodyl can be decreased when used in combination with Sodium zirconium cyclosilicate.
Dabigatran etexilate
Minor
Sodium zirconium cyclosilicate can cause a decrease in the absorption of Dabigatran etexilate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Lokelma Toxicity & Overdose RiskToo much sodium zirconium cyclosilicate could result in low potassium levels in the blood.
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Lokelma Novel Uses: Which Conditions Have a Clinical Trial Featuring Lokelma?

At present, there are 7 active trials evaluating the potential of Lokelma to manage Hyperkalemia.
Condition
Clinical Trials
Trial Phases
Hyperkalemia
4 Actively Recruiting
Phase 3, Not Applicable, Phase 2, Phase 1

Lokelma Reviews: What are patients saying about Lokelma?

4Patient Review
2/15/2020
Lokelma for High Amount of Potassium in the Blood
This powder mixes well with water and is very effective at relieving constipation. However, the copay is quite high.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about lokelma

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Lokelma lower potassium?

"LOKELMA works by binding potassium in the gastrointestinal tract, which reduces the amount of free potassium in the gut and helps to lower serum potassium levels."

Answered by AI

How fast does Lokelma lower potassium?

"LOKELMA begins lowering your potassium level within one hour of taking it. The extent of the decrease depends on your starting potassium level. Most patients have normal potassium levels within 24 to 48 hours of treatment."

Answered by AI

Is Lokelma the same as Kayexalate?

"The FDA approved oral sodium zirconium cyclosilicate (ZS-9), to be marketed as Lokelma, for the treatment of hyperkalemia. The drug reduces serum potassium levels within an hour and restoring normal levels after about 2 hours in most patients, which is better than sodium polystyrene sulfonate (Kayexalate)."

Answered by AI

What is the medication Lokelma used for?

"This medication is used to treat high levels of potassium in the blood. It works by binding to potassium in the gut and preventing it from being absorbed into the blood. This medication does not work immediately, and should not be used to treat potentially life-threatening high levels of potassium."

Answered by AI

Clinical Trials for Lokelma

Image of Seven Oaks General Hospital Chronic Disease Innovation Centre in Winnipeg, Canada.

Dietary Potassium Liberalization for Chronic Kidney Disease

18+
All Sexes
Winnipeg, Canada
The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.
Recruiting
Has No Placebo
Seven Oaks General Hospital Chronic Disease Innovation Centre (+1 Sites)Dylan Mackay, PhD
Image of Research Site in Birmingham, United States.

SZC for Hyperkalemia

No minimum age - 18
All Sexes
Birmingham, AL
Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \<18 years of age. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Enrolment will start in 2 cohorts, ages 6 to \< 12 years and 12 to \< 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to \< 6 years cohort and later in the ages 0 to \< 2 years cohort. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \< 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to \< 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP
Phase 3
Recruiting
Research Site (+9 Sites)AstraZeneca
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