LOKELMA 10 g/10g
sodium zirconium cyclosilicate · POWDER, FOR SUSPENSION · AstraZeneca Pharmaceuticals LP
LOKELMA is a powder, for suspension containing sodium zirconium cyclosilicate at 10 g/10g, taken oral. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- LOKELMA
- Generic Name
- sodium zirconium cyclosilicate
- NDC Code (Product)
0310-1110- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 10 g/10g
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA207078
- Marketing Start
- 09/04/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14) ] . LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. ( 1 ) Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended starting dose is 10 g administered three times a day for up to 48 hours. ( 2.1 ) • 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. ( 2.1 ) Patients on Chronic Hemodialysis • Recommended starting dose is 5 g once daily on non-dialysis days. ( 2.2 ) See full Prescribing Information for additional dosing instructions, as well as reconstitution and administration instructions for the oral suspension. 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 [see Dosage and Administration (2.3) ] . For continued treatment, the recommended dose is 10 g once daily. Monitor serum potassium and adjust the dose of LOKELMA based on the serum potassium level and desired target range. During maintenance treatment, up-titrate based on the serum potassium level at intervals of 1-week or longer and in increments of 5 g. Decrease the dose of LOKELMA or discontinue if the serum potassium is bel…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
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 [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] . LOKELMA is not expected to impact systemic exposure of drugs that do not exhibit pH-dependent solubility and so spacing is not needed if it has been determined that the concomitant medication does not exhibit pH-dependent solubility. In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA. ( 2.3 , 7 , 12.3 )
Adverse Reactions
6 ADVERSE REACTIONS 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 of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The total exposure to LOKELMA in the safety and efficacy clinical trials of patients not on dialysis with hyperkalemia was 1,760 patients with 652 patients exposed to LOKELMA for at least 6 months and 507 patients exposed for at least one year. The population (n=1,009) in the placebo-controlled trials included patients aged 22 to 96 years, females (n=454), Caucasians (n=859) and Blacks (n=130). Patients had hyperkalemia in association with comorbid diseases such as chronic kidney disease, heart failure, and diabetes mellitus. In placebo…
Frequently Asked Questions
What is LOKELMA used for?
LOKELMA contains sodium zirconium cyclosilicate. It is a powder, for suspension taken oral. Consult your doctor for specific uses.
Is LOKELMA a controlled substance?
LOKELMA is not classified as a controlled substance by the DEA.
What is the generic name for LOKELMA?
The generic name for LOKELMA is sodium zirconium cyclosilicate. There are no other listed brand versions of sodium zirconium cyclosilicate.
What is the NDC code for LOKELMA 10 g/10g?
The NDC (National Drug Code) for LOKELMA 10 g/10g is 0310-1110, listed by AstraZeneca Pharmaceuticals LP.
Other LOKELMA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)