Mayzent

Approved Uses

Mayzent is used to treat adults with relapsing forms of multiple sclerosis (MS). This includes several specific types of the condition:

• Clinically isolated syndrome (CIS): This is a first episode of neurological symptoms that lasts at least 24 hours and may be the first sign of MS.
• Relapsing-remitting disease (RRMS): This is a form of MS where patients have clear attacks (relapses) followed by periods of partial or complete recovery (remissions).
• Active secondary progressive disease (SPMS): This is a stage of MS that follows relapsing-remitting MS, where the disease steadily worsens but the patient still experiences active relapses or new activity on imaging tests.

The medication is intended to help decrease the frequency of relapses and may help delay the worsening of physical disability associated with the disease. It is not a cure for MS, but it is used as a long-term treatment to manage the condition and its progression.

How Mayzent Works

Mayzent is a type of medication known as a sphingosine 1-phosphate (S1P) receptor modulator. It works by interacting with specific receptors on the surface of lymphocytes, which are white blood cells that play a key role in the immune system.

Regulating Immune Cell Movement

In multiple sclerosis (MS), the immune system mistakenly attacks the protective covering of nerves (myelin) in the brain and spinal cord. Lymphocytes are the primary cells responsible for this attack. Mayzent binds to S1P receptors on these cells, which prevents them from leaving the lymph nodes and entering the bloodstream.

Protecting the Central Nervous System

By keeping these inflammatory cells trapped in the lymph nodes, Mayzent reduces the number of lymphocytes that can reach the central nervous system. This process helps to:

• Lower inflammation: Reducing the number of immune cells in the brain and spinal cord helps decrease the inflammation that leads to MS symptoms and relapses.
• Prevent nerve damage: With fewer immune cells attacking the myelin, the medication helps slow down the progression of physical disability and the formation of new brain lesions.

Common Side Effects

The most frequently reported side effects of Mayzent include:

• Headache
• High blood pressure (hypertension)
• Nausea or diarrhea
• Dizziness
• Pain in the arms or legs
• Changes in liver function test results

Serious Side Effects

Mayzent can cause serious side effects that require immediate medical attention. These include:

• Infections: Because Mayzent lowers white blood cell counts, it increases the risk of serious or life-threatening infections.
• Vision Problems: Swelling in the back of the eye (macular edema) can cause blurred vision or a blind spot in the center of your vision.
• Heart Rhythm Changes: A slow heart rate (bradycardia) or irregular heartbeat may occur, particularly when starting the medication.
• Liver Injury: Symptoms may include yellowing of the skin or eyes, dark urine, or nausea and vomiting.
• Breathing Issues: Some patients may experience new or worsening shortness of breath.
• Skin Cancer: An increased risk of certain skin cancers, such as basal cell carcinoma or melanoma, has been reported.
• Brain Conditions: A rare but serious condition called posterior reversible encephalopathy syndrome (PRES) can cause sudden severe headache, confusion, or seizures.

Infection Risk

Mayzent affects the immune system by lowering white blood cell counts, which can increase the risk of serious or life-threatening infections. Healthcare providers typically check for active infections before treatment begins. There have been reports of progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, in patients taking medications in this class.

Heart Conditions

This medication can cause the heart rate to slow down, particularly when treatment starts. It is generally not used by individuals who have had a recent heart attack, unstable angina, stroke, or certain types of heart failure within the last six months. It is also avoided in those with specific heart rhythm disorders unless a pacemaker is present.

Genetic Testing Requirements

A blood test to check the CYP2C9 genotype is required before the first dose. This test determines how the body metabolizes the drug. Certain genetic patterns may prevent the use of Mayzent or require a specific dosage adjustment.

Vision Changes

Some individuals may develop macular edema, a condition involving fluid buildup in the center of the retina. Eye examinations are often recommended before starting treatment and if vision changes occur. The risk is higher for those with diabetes or a history of eye inflammation (uveitis).

Additional Precautions

• Liver Function: Mayzent can cause elevated liver enzymes. Monitoring through blood tests is usually necessary to check for liver injury.
• Blood Pressure: Increases in blood pressure have been observed during treatment and should be monitored.
• Skin Cancer: There is a potential risk for skin cancers, including basal cell carcinoma and melanoma. Periodic skin examinations and protection from sunlight are advised.
• Respiratory Effects: The medication may lead to a decrease in lung function in some patients.
• Pregnancy and Contraception: Mayzent may cause harm to a developing fetus. Effective birth control should be used during treatment and for at least 10 days after stopping the medication.

Pregnancy

Mayzent can cause harm to a developing fetus if taken during pregnancy. Before starting this medication, a pregnancy test is typically required to ensure the patient is not pregnant. Individuals who can become pregnant should use effective contraception during treatment and for at least 10 days after their last dose of Mayzent.

If you become pregnant while taking this medication, you should contact your healthcare provider immediately. There is a pregnancy registry available to monitor the health of individuals and their babies who were exposed to Mayzent during pregnancy.

Breastfeeding

It is currently unknown whether Mayzent passes into human breast milk or how it might affect a nursing infant. Because of the potential for serious side effects in a baby, breastfeeding is generally not recommended while taking this medication. Patients should discuss the risks and benefits of breastfeeding with their healthcare provider to determine the best course of action.

Dosage Forms

Mayzent is available in the following form:

• Oral Tablet: This medication is produced as film-coated tablets that are taken by mouth.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Mayzent in March 2019. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, which includes:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease

Regulatory Requirements and Testing

Before starting treatment, the FDA requires specific testing to ensure the medication is safe for the individual patient:

• Genetic Testing: Patients must undergo a blood test to determine their CYP2C9 genotype. This test identifies how the body breaks down the medication. Mayzent is contraindicated in patients with a CYP2C9*3/*3 genotype.
• Cardiac Evaluation: Because the medication can affect heart rate, healthcare providers must review the patient's cardiac history. It is not approved for use in patients who have experienced certain heart conditions within the last six months, such as heart attack, unstable angina, stroke, or certain types of heart failure.
• Liver Function: Baseline liver function tests are typically required before initiation.

Insurance and Prior Authorization

Most insurance plans cover Mayzent, but they often require prior authorization. This is a process where your healthcare provider must get approval from your insurance company before the medication will be covered. Your specific out-of-pocket costs, such as copays or coinsurance, will be determined by your individual insurance plan and whether you have met your deductible.

Financial Assistance Programs

The manufacturer of Mayzent may offer support programs to help reduce the cost of the medication. These can include copay cards for people with commercial insurance or patient assistance programs for those who are uninsured or underinsured. Additionally, some non-profit organizations provide financial aid or grants to help cover the costs of multiple sclerosis treatments.

Generic Availability

Mayzent is currently only available as a brand-name drug. There is no generic version available at this time. Generic drugs usually cost significantly less than brand-name drugs, but they cannot be produced until the patent for the original medication expires.

Pharmacy Selection

Mayzent is often dispensed through specialty pharmacies rather than standard retail pharmacies. Your insurance company may require you to use a specific specialty pharmacy to receive coverage for the drug. Prices can vary between these providers, so it is important to verify coverage with your insurance carrier.