Lokelma v2

APRIL 2022

Modern Potassium Binder Shown to Treat Hyperkalemia in Patients Who Have Chronic Kidney Disease

In 2014, an estimated 3.7 million adults in the U.S. were diagnosed with hyperkalemia (HK), which is when the blood has higher than normal potassium levels (over 5.0 mmol/L). HK can be associated with health conditions such as diabetes, high blood pressure, heart failure or chronic kidney disease (CKD), or certain medications used to treat these conditions. CKD is a serious and progressive condition defined by decreased kidney function. In later stages of CKD, when the kidneys fail, dialysis can help perform kidneys' functions to remove waste, excess fluids and potassium from the blood. HK can affect patients with CKD regardless of whether or not they are on dialysis. After years of dealing with CKD and a failed kidney transplant, Christina Atwell’s* doctors recommended she go on dialysis in 2006. The process helped Atwell, but some of the medications prescribed to treat other conditions were affecting her lab values— including an abnormally high level of potassium in her blood.

Atwell was diagnosed with HK. Patients with CKD, like Atwell, who are on dialysis as well as those who are on medications that treat certain health conditions are at increased risk for HK. While dialysis sessions can also help lower high potassium, potassium levels can increase in the time between dialysis sessions resulting in pre-dialysis HK (high potassium levels, when checked prior to the start of a dialysis session). HK has often been managed with a low potassium diet or by reducing or discontinuing certain medications. These medications are often used to manage patients who have CKD, diabetes, or high blood pressure, and are recommended by guidelines to be prescribed at the highest tolerated dose. However, some of these medications can cause HK. Reducing or discontinuing these medications may not adequately control HK and could lead to suboptimal treatment of the conditions they are prescribed for. “Hyperkalemia oftentimes does not present itself with any symptoms, but when it does, it can present with muscle weakness, tingling, nausea, heart palpitations or arrythmia, or paralysis,” says Dr. Jessica Coleman, MD*, a Nephrologist at Beaufort Memorial Hospital in South Carolina.

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Which Treatment Is Right For You?

Which type of home treatment is right for you may depend on your daily schedule, travel preferences, work commitments, and lifestyle, but both offer distinct benefits, including:

The flexibility to schedule treatments around your personal and professional schedule Fewer dietary restrictions Fewer medications Fewer trips to the dialysis center The ability to administer your treatment without assistance The ability to maintain the social and work life you love

LOKELMA is a tasteless and odorless powder for oral use, which made it a desirable option for Atwell. Atwell’s doctor indicated she would need to empty the LOKELMA packet into a cup with at least 3 tablespoons of water, stir, and drink immediately, repeating steps if powder remains in the glass. It doesn’t have to be taken with food. In general, other oral medications should be taken at least 2 hours before or 2 hours after taking LOKELMA. For patients on hemodialysis like Atwell, LOKELMA should only be taken on non-dialysis days. Doctors may monitor potassium levels and adjust the dose as needed. LOKELMA should be taken exactly as prescribed for as long as prescribed. In a clinical trial for patients on dialysis, a greater portion of patients were responders (defined as maintained a pre-dialysis serum potassium between 4.0- 5.0 mEq/L on at least 3 out of 4 dialysis treatments after the long inter-dialytic interval with no rescue therapy) in the LOKELMA arm as compared to placebo and LOKELMA achieved and sustained lower pre-dialysis potassium levels vs placebo with continued treatment. The safety of LOKELMA was comparable to placebo. The most common side effects from this clinical trial were gastrointestinal disorders (19.8% in the LOKELMA group vs. 17.2% of patients receiving placebo). Pre-dialysis hypokalemia or low potassium (serum potassium value of <3.5 mmol/L) was reported in 5% of patients of both the LOKELMA and the placebo groups.

While Totten uses PD, deciding the type of home treatment that is right for you may depend on your daily schedule, travel preferences, work commitments, your doctor’s recommendations, and lifestyle. Both offer distinct benefits, including:

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Dr. Coleman encouraged patients with hyperkalemia, especially those who have CKD, to speak with doctors about their treatment options. "I participated in a clinical trial that compared LOKELMA to placebo. As it turned out, I received the active drug, and it helped lower my potassium. My doctor prescribed it for me after the trial, and I have been taking it ever since. For me, I think it’s great,” says Atwell. Please continue reading for LOKELMA Important Safety Information. If you think you have symptoms of hyperkalemia, talk to your doctor today. Learn more at www.lokelma.com. *This article is sponsored by AstraZeneca. Christina Atwell and Dr. Jessica Coleman were compensated by AstraZeneca to share their personal experiences with LOKELMA as a patient and provider, respectively. Kidney Disease Improving Global Outcomes (KDIGO) 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease and KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease

IMPORTANT SAFETY INFORMATION FOR LOKELMA (sodium zirconium cyclosilicate) 5g and 10g for oral suspension What is the most important thing I should know about LOKELMA? LOKELMA can cause swelling (edema) caused by fluid retention in your body (such as hands, ankles, feet). • LOKELMA contains 400 mg of sodium in each 5 g dose. Watch 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 are not on dialysis, your doctor may also tell you to increase the dose of your diuretic If you are a hemodialysis patient: • Do not take LOKELMA on dialysis days • Tell your doctor if you suddenly feel sick such as decreased oral intake of food or fluids or diarrhea, as you may be at risk of developing low levels of potassium in your blood while on LOKELMA; therefore, your dose of LOKELMA may need to be adjusted Tell your doctor(s) you are taking LOKELMA before having an abdominal X-ray as it may appear on the X-ray. What should I tell my doctor before taking LOKELMA? Before taking LOKELMA, tell your doctor about all your medical conditions, including • problems 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) • problems with your bowels after surgery What are the most common side effects with LOKELMA? The most common side effect of LOKELMA is swelling in your body caused by fluid retention. Tell your doctor if you have any side effects that bother you or do not go away Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. LOKELMA may affect how some oral medicines work. Ask your doctor or pharmacist if you need to take LOKELMA 2 hours before or after other oral medicines APPROVED USE LOKELMA is a prescription medication for the treatment of high levels of potassium in the blood (hyperkalemia) in adults Please see the full Prescribing Information for LOKELMA. You may report side effects related to AstraZeneca products by clicking here.

The increases in Atwell’s potassium levels were frequent, and at one point reached 6.7 mmol/L. Atwell’s doctor prescribed a medication to treat her recurrent HK, but she found it difficult to take. During a follow up visit, her doctor told her about a clinical trial for a K binder, LOKELMA (sodium zirconium cyclosilicate), for adult patients with HK who are on hemodialysis. LOKELMA (sodium zirconium cyclosilicate) is a prescription medication for the treatment of hyperkalemia in adults and is the only FDA-approved potassium binder with efficacy and safety results in the label for adult patients with HK on dialysis. LOKELMA selectively binds to potassium in the gut and removes it from the body. However, LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

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