Sodium zirconium cyclosilicate

What is Sodium zirconium cyclosilicate?

Sodium zirconium cyclosilicate (LOKELMA) is a potassium binder indicated for the treatment of hyperkalemia.

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What are the uses of this medicine?

• This medicine is used for the treatment of hyperkalemia in adults.

How does this medicine work?

• LOKELMA (sodium zirconium cyclosilicate) is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium.
• In vitro, LOKELMA has a high affinity for potassium ions, even in the presence of other cations such as calcium and magnesium.
• LOKELMA increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.
• Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, thereby lowering serum potassium levels.

Who Should Not Use this medicine ?

Limitation of Useː

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

What drug interactions can this medicine cause?

• In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA.
• LOKELMA can transiently increase gastric pH.
• As a result, LOKELMA can change the absorption of co-administered drugs.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosageː

• For initial treatment of hyperkalemia, the recommended dose of LOKELMA is 10 g administered three times a day for up to 48 hours.
• 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.

Patients on Chronic Hemodialysisː

• 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.

Administration

• In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA.
• Administer LOKELMA orally as a suspension in water.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As oral suspension: 5 g per packet
• As oral suspension: 10 g per packet

This medicine is available in fallowing brand namesː

• LOKELMA

What side effects can this medication cause?

The most common side effects of this medicine include:

• mild to moderate edema

What special precautions should I follow?

• Avoid use of LOKELMA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders.
• 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.
• Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed.
• Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia on LOKELMA (e.g., illnesses associated with decreased oral intake, diarrhea). Consider adjusting Lokelma dose based on potassium levels in these settings.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• LOKELMA is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• SODIUM ZIRCONIUM CYCLOSILICATE

Who manufactures and distributes this medicine?

• Manufactured by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

What should I know about storage and disposal of this medication?

• Store LOKELMA at 15°C-30°C (59°F-86°F).

• Dailymed label info on Sodium zirconium cyclosilicate
• FDA Sodium zirconium cyclosilicate

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