LOKELMA

LOKELMA is an inorganic, insoluble compound that is not subject to enzymatic metabolism. In a clinical study in patients with hyperkalemia in which zirconium concentrations were measured in the urine and blood, zirconium concentrations were similar in treated and untreated patients (i.e., either undetectable or around the lower limit of quantification of the assay). An in vivo mass balance study in rats showed that LOKELMA was recovered in the feces with no evidence of systemic absorption. Drug ...

14.1

Study 1The effectiveness of LOKELMA in lowering serum potassium was demonstrated in a two-part, double-blind, randomized, placebo-controlled clinical trial (NCT01737697) in patients with hyperkalemia (5 to 6.5 mEq/L, mean potassium 5.3 mEq/L), Study 1. In the first phase of the trial (the acute phase), 753 patients were randomized to receive one of four doses of LOKELMA (1.25, 2.5, 5 or 10 g) or placebo, administered three times daily for the initial 48 hours with meals. The mean age of patients was 66 years, 59% of patients were men, and 86% were Caucasian. Approximately 60% of patients...

The following adverse reactions are discussed in greater detail elsewhere in the label:

• Edema [see Warnings and Precautions (5.2) ] . Most common adverse reactions with LOKELMA: mild to moderate edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies o...

None. None. ( 4 )

• Gastrointestinal Adverse Events in Patients with Motility Disorders. ( 5.1 )
• Edema. ( 5.2 )
• Hypokalemia in patients on hemodialysis. ( 5.3 )
• LOKELMA has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.4 ) 5.1 Gastrointestinal Adverse Events in Patients with Motility Disorders Avoid use of LOKELMA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel m...

7 DRUG INTERACTIONS 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...