Mayzent (siponimod)

What is Mayzent?

Mayzent is a brand-name prescription medication that’s FDA-approved to treat certain types of multiple sclerosis (MS) in adults. MS is a disease in which your immune system (your body’s defense against infection) mistakenly attacks your brain and spinal cord.

Mayzent is used to treat the following conditions*:

• clinically isolated syndrome (CIS)
• relapsing-remitting MS (RRMS)
• active secondary progressive MS

*For detailed information on these conditions, see the “Mayzent for MS” section below.

Mayzent is a type of drug called a spingosine-1-phosphate receptor modulator. Mayzent is believed to help ease MS symptoms by decreasing the number of white blood cells that attack your brain and spinal cord.

Mayzent comes as a tablet that you swallow. It’s available in two strengths: 0.25 mg and 2 mg. You’ll take Mayzent once a day.

FDA approval

The Food and Drug Administration (FDA) approved Mayzent in March 2019.

Effectiveness

For information about the effectiveness of Mayzent in treating MS, see the “Mayzent for MS” section below.

Mayzent generic

Mayzent is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Mayzent contains the active drug siponimod.

Mayzent side effects

Mayzent can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Mayzent. These lists don’t include all possible side effects.

For more information on the possible side effects of Mayzent, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Mayzent, you can do so through MedWatch.

Mild side effects

Mild side effects of Mayzent can include*:

• headache
• swelling or pain in the arms or legs
• nausea
• diarrhea
• feeling dizzy

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Mayzent. To learn about other mild side effects, talk with your doctor or pharmacist or visit Mayzent’s Medication Guide.

Serious side effects

Serious side effects from Mayzent aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Decreased lung function. Symptoms can include:
  • trouble breathing
  • chest pain
  • wheezing
  • feeling tired
• Increased blood pressure. Symptoms can include:
  • headache
  • chest pain
  • trouble breathing
• Posterior reversible encephalopathy syndrome (a condition caused by swelling in your brain). Symptoms can include:
  • blindness
  • confusion
  • feeling tired or lacking energy
  • headache
  • seizures
• Severe increase in disability (new or worsening multiple sclerosis symptoms) when stopping Mayzent treatment. Symptoms can include:
  • changes in vision
  • tingling
  • numbness
  • dizziness

Other serious side effects, explained in more detail below in “Side effect details,” include:

• allergic reaction
• infections such as sinus infections or bronchitis
• eye problems such as macular edema (swelling in the eye)
• decreased heart rate
• liver problems, including increased levels of liver enzymes (special proteins made in the liver)

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Mayzent. However, it’s not known how many people had allergic reactions to Mayzent in clinical trials.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Mayzent. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Infections

Mayzent use may increase the risk of developing an infection. In a clinical trial, 49% of people who took Mayzent developed an infection. The trial also showed that 49.1% of people who took a placebo (treatment with no active drug) developed an infection.

About 2.9% of people who took Mayzent had a serious infection, compared with 2.5% of people who took a placebo.

Mayzent weakens your immune system (your body’s defense against infection), which can cause you to get an infection more easily than usual. Sometimes, these infections can be serious or even fatal.

Infections that were most common in people who took Mayzent included:

• infections caused by the herpes virus, such as shingles
• bronchitis
• upper respiratory infections (common cold)
• sinus infections
• fungal infections

Symptoms of an infection can include shortness of breath, stuffy nose, rash, fever, or cough. If you develop any of these symptoms while taking Mayzent, tell your doctor as soon as possible. Getting treatment for the infection right away may help prevent it from becoming serious.

Eye problems

Eye problems may occur with Mayzent. Specifically, the drug may increase the risk of developing a type of eye swelling called macular edema. It occurs when you have too much fluid in the center of your eye.

In clinical trials, 1.8% of people who took Mayzent developed macular edema. In comparison, only 0.2% of people who took a placebo developed macular edema. Most people who had macular edema developed symptoms within their first 4 months of treatment.

Symptoms of macular edema can include:

• blurry vision
• changes in vision
• changes in the way you see colors (they may look more faded, for example)

Before you start taking Mayzent, your doctor may have you get an eye exam. This will help your doctor and eye doctor see if your vision becomes worse during your treatment.

If you notice any changes in your vision while taking Mayzent, tell your doctor right away. They may have you stop taking Mayzent, depending on your symptoms. Then they may recommend a different multiple sclerosis (MS) treatment.

Slow heart rate

Mayzent may slow down your heart rate. In a clinical trial, a slow heart rate occurred in 4.4% of people who took Mayzent, compared with only 2.9% of people who took a placebo.

Because the drug may cause your heart rate to slow, you’ll start taking Mayzent at a low dose and slowly increase the dose over 5 to 6 days or so. The biggest change in heart rate usually occurs after the first dose, when the average decrease was about 5 to 6 beats a minute.

Although a decrease in heart rate may occur after you start taking Mayzent, after about day 6, your heart rate should start increasing again. After taking the drug for 10 days, your heart rate should be about the same as it was before you started taking Mayzent.

If you develop symptoms of a slow heart rate, such as feeling dizzy or tired, or have trouble catching your breath, tell your doctor.

They may monitor your heart rate to help make sure it doesn’t get too low. A decreased heart rate could lead to serious conditions such as heart block (a type of abnormal electrical activity in your heart).

Liver problems

Liver problems such as increased levels of liver enzymes can occur with Mayzent. (Liver enzymes are special proteins made in the liver.) High levels may be a sign of liver injury.

In a clinical study, increased liver enzyme levels occurred in 10.1% of people who took Mayzent compared with 3.7% of people who took a placebo.

For most people who had a rise in their liver enzyme levels, the changes occurred within the first 6 months of Mayzent treatment.

Your doctor will probably first observe any rise in your levels by looking at the results of your blood tests. But there are symptoms of liver injury that you may notice yourself. These can include:

• belly pain
• yellowing of your skin or the white of your eyes
• nausea or vomiting

If you develop any of these symptoms, tell your doctor right away. If your levels become too high, your doctor may switch you to a different medication to treat your MS.

Alternatives to Mayzent

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Mayzent, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for MS

Other drugs may be used to treat relapsing forms of multiple sclerosis (MS), in addition to clinically isolated syndrome (CIS). Technically, CIS isn’t MS. But sometimes CIS may be grouped with relapsing forms of MS.

Examples of these drugs include:

• fingolimod (Gilenya)
• dimethyl fumarate (Tecfidera)
• teriflunomide (Aubagio)
• alemtuzumab (Lemtrada)
• natalizumab (Tysabri)
• interferon beta-1a (Avonex)
• interferon beta-1b (Betaseron)
• glatiramer acetate (Copaxone)
• peginterferon beta-1a (Plegridy)
• ocrelizumab (Ocrevus)
• cladribine (Mavenclad)

Mayzent vs. Gilenya

You may wonder how Mayzent compares with other medications that are prescribed for similar uses. Here we look at how Mayzent and Gilenya are alike and different.

Ingredients

The active drug ingredient in Mayzent is siponimod. The active drug ingredient in Gilenya is fingolimod.

Uses

The Food and Drug Administration (FDA) has approved Mayzent and Gilenya to treat certain types of multiple sclerosis (MS). MS is a disease in which your immune system (your body’s defense against infection) mistakenly attacks your brain and spinal cord.

Mayzent and Gilenya are used to treat the following conditions*:

• clinically isolated syndrome (CIS)
• relapsing-remitting MS (RRMS)
• active secondary progressive MS

*For detailed information on these conditions, see the “Mayzent for MS” section below.

Mayzent is approved to treat only adults with MS. However, Gilenya is approved to treat adults and children ages 10 years and older with MS.

Drug forms and administration

Mayzent comes as a tablet that you swallow. You’ll take the drug once a day.

Gilenya comes as a capsule that you swallow. You’ll take the medication once a day.

Side effects and risks

Mayzent and Gilenya both contain drugs that are used to treat certain forms of MS, as well as CIS. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug or with both Mayzent and Gilenya (when taken individually).

• Can occur with Mayzent:
  • feeling dizzy
  • swelling of the arms or legs
• Can occur with Gilenya:
  • cough
  • back pain
  • belly pain
• Can occur with both Mayzent and Gilenya:
  • headache
  • nausea
  • diarrhea
  • pain in the arms or legs

Serious side effects

These lists contain examples of serious side effects that can occur with Mayzent, with Gilenya, or with both drugs (when taken individually).

• Can occur with Mayzent:
  • no unique serious side effects
• Can occur with Gilenya:
  • a rare but serious infection in your brain called progressive multifocal leukoencephalopathy (PML)
  • tumefactive MS (a type of MS in which there’s a mass in your brain)
  • increased risk of skin cancers such as basal cell carcinoma or melanoma
• Can occur with both Mayzent and Gilenya:
  • infections such as sinus infections or bronchitis
  • eye problems such as macular edema (swelling in the eye)
  • liver problems, including increased levels of liver enzymes (special proteins made in the liver)
  • allergic reaction
  • decreased lung function
  • increased blood pressure
  • decreased heart rate
  • severe increase in disability (new or worsening MS symptoms) when stopping treatment
  • posterior reversible encephalopathy syndrome (a condition caused by swelling in your brain)

Effectiveness

The only conditions both Mayzent and Gilenya are used to treat are certain types of MS, as well as CIS.

These drugs haven’t been directly compared in clinical studies, but studies have found both Mayzent and Gilenya to be effective for treating certain types of MS, as well as CIS.

Costs

Mayzent and Gilenya are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Mayzent generally costs less than Gilenya. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Mayzent vs. Ocrevus

Like Gilenya (above), the drug Ocrevus has uses similar to those of Mayzent. Here’s a comparison of how Mayzent and Ocrevus are alike and different.

Ingredients

The active drug ingredient in Mayzent is siponimod. The active drug ingredient in Ocrevus is ocrelizumab.

Uses

The Food and Drug Administration (FDA) has approved Mayzent and Ocrevus to treat certain types of multiple sclerosis (MS) in adults. MS is a disease in which your immune system (your body’s defense against infection) mistakenly attacks your brain and spinal cord.

Mayzent and Ocrevus are used to treat the following conditions*:

• clinically isolated syndrome (CIS)
• relapsing-remitting MS (RRMS)
• active secondary progressive MS

*For detailed information on these conditions, see the “Mayzent for MS” section below.

Ocrevus is also approved to treat primary progressive MS (PPMS). It’s currently the only drug that’s approved to treat PPMS.

Drug forms and administration

Mayzent comes as a tablet that you swallow. You’ll take it once a day.

Ocrevus comes in a vial and is given as an infusion. This is an injection into your vein that’s given over a period of time. You’ll receive two infusions of Ocrevus in the first 3 weeks, and then it’s given every 6 months afterward. The infusions take a few hours to complete.

Side effects and risks

Mayzent and Ocrevus both contain drugs that are used to treat certain forms of MS, as well as CIS. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug or with both Mayzent and Ocrevus (when taken individually).

• Can occur with Mayzent:
  • headache
  • swelling in the arms or legs
  • nausea
  • feeling dizzy
• Can occur with Ocrevus:
  • reaction at the site of the infusion, such as rash or redness
• Can occur with both Mayzent and Ocrevus:
  • diarrhea
  • pain in the arms or legs

Serious side effects

These lists contain examples of serious side effects that can occur with Mayzent, with Ocrevus, or with both drugs (when taken individually).

• Can occur with Mayzent:
  • eye problems such as macular edema (swelling in the eye)
  • liver problems, including increased levels of liver enzymes (special proteins made in the liver)
  • decreased heart rate
  • decreased lung function
  • increased blood pressure
  • severe increase in disability (new or worsening MS symptoms) when stopping treatment
  • posterior reversible encephalopathy syndrome (a condition caused by swelling in your brain)
• Can occur with Ocrevus:
  • serious infusion reactions such as trouble breathing or increased heart rate
  • increased risk of cancer such as breast cancer
• Can occur with both Mayzent and Ocrevus:
  • infections such as sinus infections or bronchitis
  • allergic reaction

Effectiveness

Mayzent and Ocrevus have different FDA-approved uses, but they’re both used to treat certain forms of MS, as well as CIS.

These drugs haven’t been directly compared in clinical studies, but studies have found both Mayzent and Ocrevus to be effective for treating certain forms of MS, as well as CIS.

Costs

Mayzent and Ocrevus are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Mayzent costs significantly more than Ocrevus. This is because you’d take Mayzent every day, but you’d receive Ocrevus only a few times a year. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Mayzent for MS

The Food and Drug Administration (FDA) approves prescription drugs such as Mayzent to treat certain conditions.

Mayzent is used to treat certain forms of multiple sclerosis (MS). MS is a disease where your immune system (your body’s defense against infection) mistakenly attacks the coating of your brain and spinal cord.

This coating is called the myelin sheath, and it’s what helps your brain and spinal cord communicate with the rest of your body.

With MS, the communication between your brain and spinal cord and the rest of your body is interrupted. Symptoms of MS may include muscle weakness, trouble walking, or numbness and tingling.

With relapsing forms of MS, your disease symptoms worsen (relapses). But sometimes, the MS symptoms may stop getting worse for a period of time (remission). For example, MS symptoms such as numbness or tingling may become more severe or frequent and then stop getting worse for a while.

The conditions that Mayzent is approved to treat are:

• Clinically isolated syndrome*. The first symptoms of MS are known as clinically isolated syndrome (CIS), and they last at least for 24 hours. However, not everyone who has CIS will develop MS.
• Relapsing-remitting MS. With relapsing-remitting MS (RRMS), your MS symptoms go through cycles of relapse and remission.
• Active secondary progressive MS. This form of MS starts out as RRMS. However, at some point, you may stop having times of remission, and your symptoms keep getting worse. This is when RRMS becomes secondary progressive MS (SPMS). “Active” means that an MRI scan shows that the MS is more active or your symptoms flare up and get worse.

* Technically, CIS isn’t MS. But sometimes CIS may be grouped with relapsing forms of MS.

Effectiveness

Mayzent has shown to be an effective medication to treat relapsing forms of MS, as well as CIS.

In a clinical trial of people with active SPMS, the drug reduced the rates of relapses by 55% more than in people who took a placebo (treatment with no active drug).

• People who took Mayzent had an average of 0.071 relapses a year. In comparison, people who took a placebo had an average of 0.16 relapses a year.
• Researchers also found that about 26% of people who took Mayzent reported that their MS symptoms worsened over the course of the study. In comparison, 32% of people who took a placebo reported that their MS symptoms got worse over the same time frame.

The effectiveness rates of Mayzent in treating CIS and RRMS aren’t known.

Mayzent dosage

The Mayzent dosage your doctor prescribes will depend on several factors. These include:

• other medical conditions you may have
• genetic testing

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Mayzent comes as a tablet that you swallow. It’s available in two strengths: 0.25 mg and 2 mg.

Dosage for MS

The Mayzent dosage to treat multiple sclerosis (MS) depends on the results of genetic testing that you’ll have before you start taking the medication.

The testing helps make sure that Mayzent is safe for you and determines what dose is best for you. For more about Mayzent safety, see the “Mayzent precautions” section below.

The genetic testing will look at your CYP2C9 genotype. (CYP2C9 is a specific protein, and a genotype is the genetic makeup of the protein.) The results show your doctor how fast your body will get rid of Mayzent after each dose. If your body gets rid of the drug too quickly, you may need a higher dose.

Depending on your CYP2C9 genotype, you may take 1 mg or 2 mg of Mayzent a day. (The 1-mg or 2-mg dose is known as a maintenance dose.) But when you first start taking the drug, you’ll take a lower dose. Then your doctor will slowly increase your dose over the course of 5 or 6 days.

1-mg maintenance dose

Here’s the dosage schedule for the 1-mg maintenance dose of Mayzent:

• day 1: one 0.25-mg tablet
• day 2: one 0.25-mg tablet
• day 3: two 0.25-mg tablets
• day 4: three 0.25-mg tablets
• day 5 and beyond: four 0.25-mg tablets a day

2-mg maintenance dose

Here’s the dosage schedule for the 2-mg maintenance dose of Mayzent:

• day 1: one 0.25-mg tablet
• day 2: one 0.25-mg tablet
• day 3: two 0.25-mg tablets
• day 4: three 0.25-mg tablets
• day 5: five 0.25-mg tablets
• day 6 and beyond: one 2-mg tablet a day

What if I miss a dose?

If you miss any doses in the first few days of taking Mayzent, when your dose is still increasing, you’ll need to restart the dosing from day 1. If you have any questions about your proper dose, talk with your doctor or pharmacist.

If you’re taking a maintenance dose of either 1 mg or 2 mg of Mayzent a day and you miss your dose, take it as soon as you remember. However, if you miss taking your medication for more than 4 days in a row, you’ll have to restart the dosing from day 1.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Mayzent is meant to be used as a long-term treatment. If you and your doctor determine that Mayzent is safe and effective for you, you’ll likely take it long term.

Mayzent and alcohol

There are no known interactions between alcohol and Mayzent. However, Mayzent may cause liver problems such as increased levels of liver enzymes (special proteins made in the liver).

Because alcohol can also cause liver problems, taking Mayzent and drinking alcohol may further increase your risk of developing liver problems.

If you drink alcohol, talk with your doctor about what’s a safe amount to drink while you’re taking Mayzent.

Mayzent interactions

Mayzent can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Mayzent and other medications

Below is a list of medications that can interact with Mayzent. This list doesn’t contain all drugs that may interact with Mayzent.

Before taking Mayzent, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Mayzent and drugs that can weaken your immune system

Mayzent may weaken your immune system (your body’s defense against infection). Taking this medication along with other medications that may weaken your immune system may cause you to get infections more easily than usual. This can be dangerous.

Examples of drugs that may weaken your immune system include:

• cancer drugs such as:
  • alemtuzumab (Campath)
  • rituximab (Rituxan)
• other drugs such as:
  • adalimumab (Humira)
  • etanercept (Enbrel)

Before using Mayzent, be sure to talk with your doctor about any other medications that you’re taking or have taken recently. They can tell you if the drugs weaken your immune system.

Some medications that are used to treat multiple sclerosis (MS) can stay in your body for weeks or months. So you may have to wait until the medication is out of your body before starting treatment with Mayzent.

Mayzent and drugs that can decrease or affect heart rate

Mayzent may decrease your heart rate, especially when you first start taking it. Antiarrhythmic medications, which are used to treat an abnormal heart rhythm, can also decrease your heart rate.

So taking these medications along with Mayzent may cause your heart rate to become too low. This can be dangerous.

Examples of medications that can decrease your heart rate include:

• beta-blocker medications such as:
  • carvedilol (Coreg)
  • metoprolol (Toprol XL, Lopressor)
  • nebivolol (Bystolic)
  • sotalol (Betapace)
• other drugs such as:
  • quinidine
  • procainamide
  • amiodarone (Pacerone)
  • digoxin (Lanoxin)
  • ivabradine (Corlanor)
  • verapamil (Verelan)
  • diltiazem (Cardizem)

Before starting Mayzent treatment, tell your doctor about any medications that you’re taking. They can tell you if you’re using any drugs that can decrease your heart rate. If you are, your doctor may monitor you more often to help make sure that your heart rate doesn’t become too low.

Mayzent and CYP2C9 and CYP3A4 inhibitors

Mayzent is broken down in your body by enzymes in your liver called CYP2C9 and CYP3A4. (Enzymes are proteins that aid chemical changes.)

Taking other medications that block these enzymes from working can cause too much Mayzent to build up in your body. So you shouldn’t take Mayzent along with drugs that inhibit (block) CYP2C9 and CYP3A4.

An example of a drug that blocks both the CYP2C9 and CYP3A4 enzymes is fluconazole (Diflucan).

Before you start using Mayzent, tell your doctor about any medications that you’re taking. They can tell you if any of the drugs are CYP2C9 and CYP3A4 inhibitors. If they are, your doctor may recommend other medications.

Mayzent and CYP2C9 and CYP3A4 inducers

Mayzent is broken down in your body by enzymes in your liver called CYP2C9 and CYP3A4. Some drugs can make these enzymes work faster than usual. These drugs are called CYP2C9 and CYP3A4 inducers.

Taking these medications along with Mayzent may cause your body to break down Mayzent too quickly. As a result, your body may not absorb enough of the drug, and Mayzent won’t work as well to treat your MS.

Examples of medications that are CYP2C9 and CYP3A4 inducers include:

• rifampin (Rimactane)
• carbamazepine (Tegretol)

Be sure to go over a list of your medications with your doctor before you start taking Mayzent. They’ll be able to tell you if any of the drugs are CYP2C9 and CYP3A4 inducers. If they are, your doctor may monitor you more frequently or switch you to different medications.

Mayzent and vaccines

Before you start taking Mayzent, it’s important to keep in mind this information about vaccines.

Live vaccines

You shouldn’t get any live vaccines while you’re taking Mayzent and for least 4 weeks after your last dose.

Live vaccines have a weak form of bacteria or a virus in them. They usually don’t cause infections in healthy people.

But because Mayzent may weaken your immune system, your body may not be able to fight the bacteria or virus. So getting live vaccines while taking Mayzent may cause you to get the disease you’re trying to prevent.

Examples of live vaccines include:

• measles, mumps, rubella (MMR)
• nasal spray version of the flu shot
• smallpox
• chickenpox
• rotavirus
• yellow fever
• typhoid

Inactive vaccines

In some cases, you may need to get an inactive (not live) vaccine while using Mayzent. Your doctor will likely have you stop taking Mayzent for 1 week before getting the vaccine.

They’ll also likely have you wait at least 4 weeks after being vaccinated before you restart your Mayzent treatment. This is because inactive vaccines may not work as well to protect you from a disease if you have Mayzent in your system.

Examples of inactive vaccines include:

• flu shot
• tetanus, diphtheria, acellular pertussis (TDaP)
• hepatitis A and hepatitis B
• human papillomavirus (HPV)
• pneumonia
• meningitis
• shingles

Before you start taking Mayzent, talk to your doctor about any vaccines you need. You may be able to catch up on your vaccines before you start Mayzent treatment.

Mayzent and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Mayzent. However, you should still check with your doctor or pharmacist before using any of these products while taking Mayzent.

Mayzent and foods

There aren’t any foods that have been specifically reported to interact with Mayzent. If you have any questions about eating certain foods with Mayzent, talk with your doctor.

Mayzent cost

As with all medications, the cost of Mayzent can vary. The actual price you’ll pay will depend on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Mayzent at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Your insurance plan may require you to get prior authorization before they approve coverage for Mayzent. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Mayzent, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Mayzent, or if you need help understanding your insurance coverage, help is available.

Novartis Pharmaceuticals Corporation, the manufacturer of Mayzent, offers a program called Alongside MS. For more information and to find out if you’re eligible for support, call 877-MAYZENT (877-629-9368) or visit the program website.

How to take Mayzent

You should take Mayzent according to your doctor or healthcare provider’s instructions.

Mayzent comes as a tablet that you swallow.

When to take

You’ll take Mayzent once a day. Try to take your dose at about the same time each day. This way, you’ll always have a consistent amount of medication in your body.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Mayzent with food

You can take your dose of Mayzent with or without food.

Can Mayzent be crushed, split, or chewed?

It’s not known if Mayzent is safe and effective when it’s crushed, split, or chewed.

If you’re having trouble swallowing Mayzent tablets whole, talk with your doctor or pharmacist. They may be able to recommend easier ways of taking your medication or other drugs to treat your multiple sclerosis (MS).

How Mayzent works

Here’s some information on what multiple sclerosis (MS) is and how Mayzent works in your body.

What is MS?

MS is a disease that affects the communication between your brain and spinal cord, and the rest of your body.

People with MS have an overactive immune system (your body’s defense against infection). The immune system mistakenly attacks the coating on your nerves called the myelin sheath. The myelin sheath is what helps your brain and spinal cord communicate with the rest of your body.

Relapsing forms of MS are types of MS where your symptoms may come in waves. When you relapse, your symptoms get worse. When you’re in remission, your symptoms stay the same and stop getting worse.

What is Mayzent approved to treat?

Mayzent is approved to treat the following conditions:

• Clinically isolated syndrome*. The first symptoms of MS are known as clinically isolated syndrome (CIS), and they last at least for 24 hours. However, not everyone who has CIS will develop MS.
• Relapsing-remitting MS. With relapsing-remitting MS (RRMS), your MS symptoms go through cycles of relapse and remission.
• Active secondary progressive MS. This form of MS starts out as RRMS. However, at some point, you may stop having times of remission, and your symptoms keep getting worse. This is when RRMS becomes secondary progressive MS (SPMS). “Active” means that an MRI scan shows that the MS is more active or your symptoms flare up and get worse.

* Technically, CIS isn’t MS. But sometimes CIS may be grouped with relapsing forms of MS.

What does Mayzent do?

The exact way that Mayzent works in your body to treat MS isn’t known. However, the drug is believed to decrease the number of lymphocytes in your central nervous system (brain and spinal cord).

A lymphocyte is a type of white blood cell that’s a part of your immune system and may contribute to MS symptoms. By decreasing the number of lymphocytes in your brain and spinal cord, Mayzent may help ease symptoms of MS.

How long does it take to work?

Mayzent will begin working after you take your first dose. It may take a few doses before you notice a change in your MS symptoms.

Mayzent and pregnancy

It’s not known if Mayzent is safe for pregnant women to take. Animal studies show that this medication can be harmful to a developing baby, increasing the risk of miscarriage and birth defects. However, animal studies don’t always predict what happens in humans.

If you’re pregnant or are planning to become pregnant, talk with your doctor before taking Mayzent. They can help you review your treatment options for multiple sclerosis (MS).

Mayzent and birth control

It’s not known if Mayzent is safe to take during pregnancy.

Women should use birth control while taking Mayzent and for 10 days after their last dose. This is because after you stop taking Mayzent, it takes about 10 days until the drug is out of your body.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Mayzent.

For more information about Mayzent use and pregnancy, see the “Mayzent and pregnancy” section above.

Mayzent and breastfeeding

It’s not known if Mayzent is safe to take while breastfeeding. In animal studies, the drug was found in the breast milk of mothers who were given the drug while pregnant.

If you’re breastfeeding or are planning to breastfeed, talk with your doctor before taking Mayzent. They can review the best ways for you to feed your baby and possible treatment options for multiple sclerosis (MS).

Common questions about Mayzent

Here are answers to some frequently asked questions about Mayzent.

Why do I need a genetic test before using Mayzent?

You need to have a genetic test to determine your CYP2C9 genotype. CYP2C9 is a specific protein, and a genotype is the genetic makeup of the protein.

The test results show your doctor how fast your body will get rid of Mayzent. If your body gets rid of the drug too quickly, you may need a higher dose. (For more about doses of Mayzent, see the “Mayzent dosage” section above.)

In some cases, the genetic test may determine that Mayzent isn’t a good choice for you. If your body has trouble getting rid of Mayzent, your doctor may recommend a different medication to treat your multiple sclerosis (MS).

If you have questions about this genetic testing or Mayzent, talk with your doctor.

What other tests do I need before starting Mayzent treatment?

Besides the genetic test (mentioned above), you’ll also need some other tests to make sure that Mayzent is a good choice for you. Before you start your treatment, your doctor may perform some or all of these tests:

• Complete blood count. A complete blood count (basic blood work) shows your blood levels. By having this test before you take Mayzent, your doctor will be able to determine if any changes occur during your treatment.
• Eye exam. Mayzent may cause macular edema, which is a condition that affects fluid in the eye and can cause swelling. Having an eye exam before you start taking Mayzent will help your doctor determine if any changes occur in your eyes during your treatment.
• Electrocardiogram (ECG). An electrocardiogram (ECG) measures your heart’s electrical activity. The test is done to help make sure that you don’t have any heart problems before you start taking Mayzent. If you do have a heart condition, your doctor may monitor your heart more often or check with a cardiologist (heart doctor) before you start to take Mayzent.
• Liver function tests. Mayzent may affect your liver, so your doctor will order liver function tests within 6 months before you start your Mayzent treatment. These blood tests are help determine if there are any changes in your liver function while you’re taking Mayzent.

If you have any questions about testing that you may need before starting to take Mayzent, talk with your doctor.

Will my doctor have to monitor me for my first dose of Mayzent?

Possibly. You may need to be monitored after your first dose of Mayzent if:

• your heart rate is less than 55 beats a minute
• you have a history of first- or second-degree heart block (a type of abnormal electrical activity in your heart)
• you have a history of heart attack or heart failure

Mayzent may decrease your heart rate. So if you have any of the above heart problems and take the medication, your heart rate could drop further. Your doctor may monitor you to treat your heart rate if it becomes too low after your first dose.

You’ll be monitored for 6 hours after your dose, and your heart rate and blood pressure should be checked each hour. If your heart rate or blood pressure isn’t normal after the 6 hours, your doctor will keep monitoring you until they become normal again.

At the end of the day, your doctor will also give you an ECG. (See the above FAQ for more information on ECGs.)

If you have any questions about monitoring after your first dose of Mayzent, talk with your doctor.

What happens if I miss a dose of Mayzent when I begin taking it?

If you miss a dose within the first few days of taking Mayzent, when your dose is still increasing, you’ll need to restart the dosing from day 1. (For dosing specifics, see the “Mayzent dosage” section above.)

Mayzent may decrease your heart rate, which can be serious. To allow your body to adjust to the medication, your doctor will slowly increase the dose when you first start your Mayzent treatment. This way, you’re not taking a large dose all at once, which may cause your heart rate to drop to unsafe levels.

If you miss a dose while the dose amount is still increasing, you can confuse your body. This can cause the next dose to lower your heart rate too quickly.

However, if you miss a dose after you’ve already reached your maintenance dosage (1-mg or 2-mg tablet a day), you should just take your medication as soon as you remember. And if you miss four or more doses in a row, you’ll need to restart the dosing from day 1.

If you have any questions about when to take your next dose of Mayzent or how much you should take, talk with your doctor.

Should I avoid getting certain vaccines during Mayzent treatment?

Yes, you should avoid getting live vaccines while you’re taking Mayzent and for least 4 weeks after your last dose.

If your doctor recommends that you take a non-live vaccine, they’ll likely have you stop taking Mayzent 1 week before getting the vaccine. Then they’ll have you restart your Mayzent treatment 4 weeks after getting the vaccine. This is because vaccines may not be as effective while you’re taking Mayzent.

For more information, see the “Mayzent and vaccines” section above.

Mayzent precautions

This drug comes with several precautions. Before taking Mayzent, talk with your doctor about your health history. Mayzent may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Current infections

You shouldn’t take Mayzent if you have a current infection. This is because Mayzent can weaken your immune system (your body’s defense against infection). As a result, your body may not fight the infection as well as it normally would, and the infection could get worse.

Your doctor will treat you for any current infections before you start taking Mayzent.

Cardiovascular problems

If you have certain cardiovascular (heart and blood vessel) problems, your doctor may recommend extra monitoring or a drug other than Mayzent. These heart problems include:

• Slow heart rate. Mayzent may decrease your heart rate, especially when you first start taking the drug. So if you already have a slow heart rate (also called bradycardia), Mayzent may make it worse. Your doctor may check with your cardiologist (heart doctor) before you start taking Mayzent. You’ll likely need a heart exam to determine if the medication is safe for you to take.
• Heart block. If you have heart problems such as heart block (a type of abnormal electrical activity in your heart), you may need more monitoring before taking Mayzent. Heart block and Mayzent can decrease your heart rate, so taking the drug when you have the condition may be dangerous. Your cardiologist may check your heart more often if you take Mayzent. Or they may have you try a different medication instead.
  • Second- or third-degree heart block. If you have second- or third-degree heart block, you should not take Mayzent, unless you also have a pacemaker. (For information on heart block, see the “Heart block” section right above.) Ask your doctor what treatment is right for you.
• Other cardiovascular problems. Within the last 6 months, if you’ve had a heart attack, unstable angina, stroke, or serious heart failure, you shouldn’t take Mayzent. You also shouldn’t take Mayzent if you have sick sinus syndrome and don’t have a pacemaker. Talk with your doctor about a different medication that you can take to treat your MS.

CYP2C9*3/*3 genotype

You’ll have genetic testing before you start taking Mayzent. This is done to make sure that your body will be able to get rid of Mayzent after you take your doses.

The test also helps determine the proper dose for you to take. If you have the CYP2C9*3/*3 genotype, you shouldn’t take Mayzent. (CYP2C9*3/*3 is a specific protein, and a genotype is the protein’s genetic makeup.)

Having the CYP2C9*3/*3 genotype means that your body won’t be able to break down Mayzent as it should. As a result, too much of the drug may build up in your body. Ask your doctor what treatments other than Mayzent are better for you.

Lung problems such as asthma

Mayzent may cause a decrease in your breathing function.

If you already have a lung condition, such as asthma, you may already have trouble breathing. So taking Mayzent may make it even harder to breathe. Talk with your doctor about any lung conditions that you have before starting Mayzent treatment.

Liver problems such as hepatitis

Mayzent may cause liver problems such as increased levels of liver enzymes (special proteins made in the liver).

If you already have liver problems, such as hepatitis, Mayzent may make your liver problems worse. Talk with your doctor about any liver problems that you have before you start taking Mayzent. They can review the right treatments for you.

Pregnancy and breastfeeding

It’s not known if Mayzent is safe to take during pregnancy or while breastfeeding. For more information, please see the “Mayzent and pregnancy” and “Mayzent and breastfeeding” sections above.

Note: For more information about the potential negative effects of Mayzent, see the “Mayzent side effects” section above.

Mayzent overdose

Using more than the recommended dosage of Mayzent can lead to serious side effects.

Don’t use more Mayzent than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include a decreased heart rate. If you take too much Mayzent, your doctor may monitor you overnight to make sure that your pulse and blood pressure don’t get too low.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Mayzent expiration, storage, and disposal

When you get Mayzent from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication. The expiration date helps guarantee that the medication is effective during this time.

The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store unopened bottles of Mayzent in the refrigerator, between 35°F to 46°F (2°C and 8°C). Once opened, keep bottles of Mayzent at room temperature, between 68°F and 77°F (20°C and 25°C) for a maximum of 1 month. After that, you should dispose of the medication.

Mayzent also comes in a blister pack that you’ll likely use for your first few days of treatment, when your dose is increasing each day. You should store unopened blister packs in the refrigerator, between 35°F to 46°F (2°C and 8°C). Keep Mayzent tablets in the original blister pack until you’re ready to take them.

Once you open a blister pack, store it at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 1 week. After that, you should dispose of the medication.

Avoid storing the opened medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Mayzent and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.