LOKELMA Powder for oral suspension (2020)

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AstraZeneca Pharmaceuticals LP

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1. Indications and Usage

LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use: LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed ...

2. Dosage and Administration

2.1 Recommended Dosage For initial treatment of hyperkalemia, the recommended dose of LOKELMA is 10 g administered three times a day for up to 48 hours. Administer LOKELMA orally as a suspension in water ...

3. Dosage Forms and Strengths

For oral suspension: 5 g or 10 g of white to grey powder in a foil-lined packet.

4. Contraindications

None.

5. Warnings and Precautions

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 ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail elsewhere in the label: Edema [see Warnings and Precautions (5.2)].

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

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 ...

8.1. Pregnancy

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

8.2. Lactation

Risk Summary LOKELMA is not absorbed systemically following oral administration, and breastfeeding is not expected to result in exposure of the child to LOKELMA.

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Of the total number of subjects in clinical studies of LOKELMA, 58% were age 65 and over, while 25% were 75 and over. No overall differences in safety or effectiveness were observed between these patients ...

11. Description

LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that ...

12.1. Mechanism of Action

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 ...

12.2. Pharmacodynamics

In a study in healthy adult subjects, LOKELMA administered as 5 g or 10 g once daily for four days caused a dose-dependent increase in fecal potassium excretion. Corresponding dose-dependent decreases ...

12.3. Pharmacokinetics

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 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

The following tests for mutagenic potential of sodium zirconium cyclosilicate were negative: (1) the Ames (S. typhimurium and E. coli) test; (2) chromosomal aberration assay in Chinese ...

14. Clinical Studies

14.1 Study 1 The 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 ...

16.1. How Supplied

LOKELMA (sodium zirconium cyclosilicate) for oral suspension is supplied as a white to grey powder in foil-lined packets as follows: LOKELMA (grams) Single Packet Box of 11 Packets Box of 30 Packets ...

16.2. Storage and Handling

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

17. Patient Counseling Information

Dosing Instruct the patient how to reconstitute LOKELMA for administration. Inform the patient that it is necessary to drink the full dose [see Dosage and Administration (2.3)]. Instruct dialysis ...