• Lokelma (sodium zirconium cyclosilicate) works by binding to potassium (K+) in the small and large intestines to help remove it from the blood. The potassium is then excreted by your body.
• Lokelma is given as an oral medicine to treat high potassium levels in the blood (hyperkalemia) in adults.
• Lokelma exchanges potassium for hydrogen and sodium. It is classified as a cation exchange resin and is not absorbed into the blood. These types of drugs are often called "potassium binders".
• Potassium is a nutrient that your body needs for your muscles, nerves, heart, digestion and bone health. The kidneys normally remove potassium from the blood to help maintain an even balance. If the kidneys lose this ability, the levels of your potassium can get dangerously high. If you receive hemodialysis, potassium can also rise to unwanted levels between dialysis treatments.
• Lokelma does not work right away so it should NOT be used as an emergency treatment for life-threatening high potassium levels.

• Lokelma is used to treat high potassium levels (hyperkalemia) in adults. Normal blood potassium levels are 3.5 to 5.0 millimoles per liter (mmol/L). High potassium in the blood is associated with medical conditions like kidney disease, high blood pressure, heart failure, diabetes, and side effects of some medications.
• Potassium levels start to decline within one hour after the administration of Lokelma. In studies, normal potassium levels were reached in a median of 2.2 hours. Over 90% of patients had normal potassium levels within 48 hours. In clinical studies, ongoing treatment helped keep potassium levels within a normal range.
• Lokelma can also be prescribed for people who are on dialysis treatment.
• Lokelma is taken by mouth as an oral suspension, but it has no taste or smell, and does not expand in your digestive tract. It works by binding and removing potassium in the digestive tract so that the potassium does not get into your bloodstream.
• Talk to your doctor to determine if you need to follow a low potassium or sodium diet.
• Lokelma is not absorbed into the bloodstream after you take it. Use by a woman during pregnancy or breastfeeding is not expected to result in an exposure to the drug to the unborn child or infant.
• No differences in safety or effectiveness have been observed between older patients (those 65 years of age and older) and younger patients.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Swelling (edema) in your body (such as hands, ankles, feet) due to fluid retention. Lokelma contains 400 mg of sodium (“salt”) in each 5 g dose, which can lead to fluid retention and swelling. Ask your doctor if you need to reduce the sodium in your diet or adjust your diuretic (“water pill”) dose, if you take one.
• If you take other oral medications in addition to Lokelma, you may need to take them 2 hours before or 2 hours after taking Lokelma, as directed by your healthcare provider.
• Tell your doctor before you start treatment if you have trouble with your bowel movements, for example: severe constipation, a blockage (obstruction) in your bowel, a dry, hard stool that will not pass out of your rectum (impaction), or problems with your bowels after surgery.
• If you receive dialysis, you may be prone to illnesses that increase your risk for losing potassium from your body (for example, illnesses associated with decreased flood or fluid intake, or diarrhea). If you feel sick, tell your doctor, as your dose of Lokelma may need to be adjusted.
• It is not known if this drug is safe or effective in children under 18 years of age.

This is not a complete list of side effects, precautions or warnings, and others may occur. Call your doctor for medical advice about side effects, precautions or warnings.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Always take Lokelma exactly as your doctor prescribes it. Let your healthcare provider know about all of your medical conditions and medicines that you take before treatment. Contact your doctor if your symptoms worsen or your condition changes. Do not stop any treatment unless your healthcare provider tells you to stop.
• High potassium in your blood can lead to weakness, nausea, a dangerous change in your heartbeat, and paralysis. If you experience any of these symptoms, call 911 or get immediate medical assistance.
• Lokelma is available as a powder for oral suspension. You will learn how to mix this suspension at home. It comes in foil packets of either 5 grams (g) or 10 g for reconstitution. It has no taste or smell. You will mix the powder with a small amount of water before you drink it. It does not expand in water, so it is not expected to swell within the digestive tract. Be sure to drink the entire amount unless otherwise directed by your doctor.
• Look for signs of swelling in your body especially if you limit sodium in your diet or are likely to have fluid retention in your body due to heart or kidney problems. Your doctor may tell you to reduce the sodium in your diet. If you take a diuretic (“fluid or water pill”) your doctor may direct you to increase your dose of the diuretic.
• If you are a dialysis patient, do not take Lokelma on dialysis days. Tell your doctor if you suddenly feel sick such as a decreased oral intake of food or fluids, or the occurrence of diarrhea. Your Lokelma dose may need to be adjusted.
• Ask your doctor if you need to adjust levels of sodium or potassium in your diet while taking Lokelma. Tell your healthcare provider if you are taking Lokelma before having an abdominal (stomach area) X-ray. This medicine may appear on the X-ray.
• Before you start treatment, tell your healthcare provider if you have problems with having a bowel movement, including severe constipation, a blockage (obstruction) in your bowel, or dry hard stool that will not pass out of your rectum (impaction). Let them know if you have had problems with your bowels after surgery.
• The manufacturer offers a Savings Card that may reduce your copays to $0 if you qualify. You can download your savings card online and no activation is required. They can also offer counseling services for your insurance coverage. In the U.S., call 1-844-LOKELMA (1-844-565-3562), Monday – Friday, 8 am to 8 pm ET.

• In clinical studies, patients received 10 grams of Lokelma three times per day for up to 48 hours. Reductions in serum potassium levels were observed within one hour, and potassium levels continued to decline over 48 hours. Normal potassium levels in the blood were reached in a median time of 2.2 hours. Most patients (92%) had normal potassium levels within 48 hours. In patients who did not continue therapy, potassium levels increased.
• Lokelma was effective in lowering potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking renin-angiotensin-aldosterone system (RAAS) inhibitors, for example lisinopril (an ACE inhibitor) or losartan (an ARB).
• In an 11-month extension study, Lokelma continued to lower potassium levels in patients who stayed on treatment.
• In a placebo-controlled trial of 196 chronic hemodialysis patients, more patients were responders in the Lokelma arm as compared to the placebo group (41% vs 1%, respectively; a statistically significant effect).

Medicines that interact with Lokelma may either decrease its effect, affect how long it works for, or increase side effects. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Lokelma can decrease the absorption of other oral medicines and reduce their effectiveness. If you are taking other oral medications, you may need to take them either 2 hours before or 2 hours after you take Lokelma. Ask your doctor or pharmacist for advice.

Lokelma interacts with over 18 medications, and most of these interactions are considered moderate in severity. Common medications that may interact with Lokelma include:

• atazanavir
• atorvastatin
• dabigatran
• dasatinib
• erlotinib
• furosemide
• indinavir
• itraconazole
• ketoconazole
• levoketoconazole
• nelfinavir
• nilotinib
• posaconazole
• raltegravir
• rilpivirine
• ritonavir
• saquinavir
• tacrolimus

It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Note that this list is not all-inclusive and includes only common medications that may interact with Lokelma. You should refer to the prescribing information for Lokelma for a complete list of interactions.