Lokelma

Lokelma

Brand Name - Lokelma

Generic Name

sodium zirconium cyclosilicate

Pregnancy

Manufacturer

AstraZeneca-

AstraZeneca is a global, science-led bio pharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

US FDA pregnancy category not assigned.This drug is not systemically absorbed following oral administration and therefore maternal use is not expected to result in fetal exposure.

Approval Date

May 18,2018

Warnings/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.Advise patients to adjust dietary sodium.

Drug Interactions

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.

Side Effects

The most common side effect of Lokelma is body swelling because of its sodium content.

Mechanism of action

Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly-selective potassium-removing agent. It is administered orally, is odorless, tasteless and stable at room temperature. It captures potassium in exchange for hydrogen and sodium. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract; this reduces the concentration of free potassium and lowers serum potassium levels.

Indications

Lokelma is a drug for the treatment of Hyperkalemia in adults. Hyperkalemia is a condition in which the amount of potassium in the blood is too high. Lokelma reduces high levels of potassium in the blood and maintains the potassium at a normal level. Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly.