Can people with end stage renal disease take Mayzent?

Key Points

• The effects of end stage renal (kidney) disease or hemodialysis with the use of Mayzent (siponimod) has not been studied.
• However, due to high protein binding of Mayzent (> than 99.9%), hemodialysis is not expected to alter the blood levels of Mayzent.
• No dose adjustments of Mayzent in hemodialysis are anticipated based on protein-binding considerations. Highly protein bound drugs have less clearance through dialysis.

End stage renal disease and Mayzent

The effects of end stage renal disease or hemodialysis on the pharmacokinetics of Mayzent (siponimod) has not been studied by the manufacturer.

However, due to the high plasma protein binding of siponimod (greater than 99.9%), hemodialysis is not expected to alter the total and unbound siponimod concentration and no dose adjustments are anticipated based on these considerations.

In general, your physician should always make the final determination of your Mayzent dose based on your medical history and other medications.

Mayzent, from Novartis, is approved by the FDA for relapsing forms of multiple sclerosis, which include clinically isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS with relapses). Mayzent is classified as a sphingosine-1-phosphate (S1P) receptor modulator. Mayzent is not a cure for MS, but helps to decrease the frequency of relapse symptoms. Mayzent is used only if you have a specific genotype (CYP2C9 genetic type). Your doctor will test you for this genetic type of MS.

What is end stage renal disease?

Your kidneys are important to help clear toxins from your blood, regulate water and minerals in your body, and make urine. During end stage renal disease (often abbreviated ESRD), both of your kidneys have failed and no longer function properly to perform these functions.

End stage renal disease is the last stage of kidney disease and can lead to death. In someone with end stage kidney disease, a dialysis machine can help perform the functions of the kidney and be life-saving.

Receiving a kidney from a transplant operation is another option. End stage kidney disease is a lifelong condition unless a person can receive a kidney transplant; however, you can live with only one kidney. One healthy kidney from a donor is all that is needed to replace two diseased kidneys.

What causes end stage renal disease?

Diabetes is the top cause of end-stage renal (kidney) disease. This can occur with either type 1 or 2 diabetes, and is worsened by poor blood sugar control.

Other common causes of end-stage renal disease include:

• high blood pressure
• a build-up of cholesterol in the arteries, heart disease
• autoimmune diseases like systemic lupus erythematosus (lupus)
• genetic disorders, such as polycystic kidney disease
• exposure to certain drugs, such as:
  • certain antibiotics
  • chemotherapy
  • contrast dyes
  • pain medications

What is hemodialysis?

To treat end stage renal disease, many patients receive hemodialysis at a center specifically for this purpose. Treatments are done 3 or 4 times per week, and last around 3 to 4 hours per session.

During dialysis your blood is filtered through a filter in a hemodialysis machine to remove the waste products that your kidneys can no longer remove. Hemodialysis is a life-saving procedure.

What is kidney disease in general?

Long-term kidney disease may develop over many years and lead to end-stage kidney (or renal) disease (ESRD). There are different levels of kidney disease.

To determine your level (or stage) of kidney disease, your doctor will order various blood or urine tests from the lab, including a Glomerular Filtration Rate (GFR) and a urinalysis to check the amount of protein in your urine.

• Estimated Glomerular Filtration Rate (eGFR): the rate at which the kidneys filter wastes and extra fluid from the blood; measured in milliliters per minute. GFR is usually estimated from the person's serum creatinine, using their age, sex, and race. This number declines as kidney function worsens.
• Proteinuria: a condition in which the urine contains excessive amounts of a protein called albumin. Your doctor might order a test such as a urine albumin test to check for proteinuria.

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Stages of Chronic Kidney Disease

Can patients with kidney disease take Mayzent?

Kidney disease is usually diagnosed by your doctor using urine and blood tests. These tests measure levels of waste products known as creatinine and urea nitrogen found in urine and blood. Additional tests may be necessary to determine why the kidneys have stopped working.

No dose adjustments of Mayzent are needed in patients with renal (kidney) impairment. The concentrations of the drug (mean half-life and Cmax, total and unbound) were comparable between subjects with severe kidney impairment and healthy patients in studies done by the manufacturer looking at levels of the drug in the blood.

Unbound areas under the curves (AUCs) of Mayzent were only slightly increased by 33% when compared to healthy subjects, and it is not expected to be clinically significant.

The effects of end stage renal (kidney) disease or hemodialysis with the use of Mayzent has not been studied, but because Mayzent is very highly bound to proteins in the blood, dose adjustments of Mayzent in hemodialysis are not anticipated.

Can the elderly with kidney disease take Mayzent?

Studies of Mayzent did not include enough people over the age of 65 to determine if they will respond differently to a younger population with kidney disease. However, the elderly, due to their age, may have reduced kidney function. Other illnesses or medications can also affect kidney function.

In general, caution should be used when selecting a Mayzent dose selection for an older patient for many reasons. Be sure to tell your doctor:

• if you have kidney, liver or heart disease
• your current and past medical history
• all of the medications you take, including prescription, over-the-counter (OTC), herbal or dietary supplements. Drug interactions may affect levels of the drug in your blood.

Bottom Line

• Research is lacking on the use of Mayzent in patients with end stage renal (kidney) disease or during hemodialysis.
• During hemodialysis your blood is filtered to remove the waste products that your kidneys can no longer remove.
• However, Mayzent is a drug that is highly protein bound in the blood and hemodialysis is not expected to alter concentrations of Mayzent. Highly protein bound drugs have less clearance through dialysis.