Medical Editor: John P. Cunha, DO, FACOEP
What Is Lokelma?
Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of high blood potassium (hyperkalemia) in adults.
What Are Side Effects of Lokelma?
Lokelma may cause serious side effects including:
- hives,
- difficulty breathing, and
- swelling of your face, lips, tongue, or throat
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Lokelma include:
- mild to moderate swelling (edema)
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Lokelma
The recommended starting dose of Lokelma is 10 g administered three times a day for up to 48 hours. For maintenance treatment, the recommended dose of Lokelma is 10 g once daily.
What Drugs, Substances, or Supplements Interact with Lokelma?
Lokelma may interact with other drugs. In general, other oral medications should be administered at least 2 hours before or 2 hours after Lokelma. Tell your doctor all medications and supplements you use.
Lokelma During Pregnancy and Breastfeeding
Because Lokelma is not absorbed systemically following oral administration, maternal use is not expected to result in fetal exposure to the drug during pregnancy, and breastfeeding is not expected to result in exposure of the child to Lokelma.
Additional Information
Our Lokelma (sodium zirconium cyclosilicate) for Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Anemia Symptoms and Signs, Types, Treatment and Causes See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medicine contains sodium and may cause swelling or rapid weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
What is hemophilia? See AnswerSIDE EFFECTS
The following adverse reactions are discussed in greater detail elsewhere in the label:
- Edema [see WARNINGS AND PRECAUTIONS].
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-controlled trials in which patients who were not on dialysis were treated with once daily doses of LOKELMA for up to 28 days, edema was reported in 4.4% of patients receiving 5 g, 5.9% of patients receiving 10 g and 16.1% of patients receiving 15 g LOKELMA compared to 2.4% of patients receiving placebo. In longer-term uncontrolled trials in which most patients were maintained on doses <15 g once daily, adverse reactions of edema (edema, generalized edema and peripheral edema) were reported in 8% to 11% of patients.
Laboratory Abnormalities
In clinical trials in patients who were not on dialysis, 4.1% of LOKELMA-treated patients developed hypokalemia with a serum potassium value less than 3.5 mEq/L, which resolved with dosage reduction or discontinuation of LOKELMA. In a clinical trial of LOKELMA in patients on chronic hemodialysis, 5% of patients developed pre-dialysis hypokalemia (serum potassium <3.5 mEq/L) in both the LOKELMA and placebo groups; 3% and 1% of patients developed a serum potassium < 3.0 mEq/L in the LOKELMA and placebo groups, respectively.
DRUG INTERACTIONS
LOKELMA can transiently increase gastric pH. As a result, LOKELMA can change the absorption of coadministered 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 and CLINICAL PHARMACOLOGY]. 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.
Read the entire FDA prescribing information for Lokelma (Sodium Zirconium Cyclosilicate)
© Lokelma Patient Information is supplied by Cerner Multum, Inc. and Lokelma Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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