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Mayzent (Siponimod) - Oral

What Is Mayzent? Mayzent (siponimod) is an immune modulator used to treat people with relapsing forms of multiple sclerosis (MS).Mayzent binds to sphingosine-1-phosphate (S1P) receptors and blocks the release of lymphocytes from lymph nodes,

  • Posted on 10th May, 2022 11:15 AM
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Mayzent (Siponimod) - Oral Image

What Is Mayzent?

Mayzent (siponimod) is an immune modulator used to treat people with relapsing forms of multiple sclerosis (MS).

Mayzent binds to sphingosine-1-phosphate (S1P) receptors and blocks the release of lymphocytes from lymph nodes, thereby reducing the number of lymphocytes circulating in the blood. It is available by prescription as an oral tablet.

Drug Facts

Generic Name: Siponimod

Brand Name(s): Mayzent

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Immune modulator

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Siponimod

Dosage Form(s): Tablet

What Is Mayzent Used For?

The Food and Drug Administration (FDA) approved Mayzent to treat relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

How to Take Mayzent

Take Mayzent as prescribed, with or without food. Your healthcare provider will instruct you on how often you should take your medication (usually daily). When taking the tablets, do not split, crush, or chew them. Swallow the tablets whole.

Storage

Store unopened containers of Mayzent tablets in a refrigerator between 36 and 46 degrees Fahrenheit (F) until you are ready to use them. You can store the unopened containers of tablets at room temperature for up to three months.

Once opened, starter packs or blister packs can be stored at room temperature (68 F to 77 F) for three months. Opened bottles can be stored at room temperature for three months and should not be refrigerated after opening.

How Long Does Mayzent Take to Work?

In a clinical trial comparing Mayzent to a placebo, Mayzent showed benefit in decreasing disability progression after taking the drug daily for about three months and continuing throughout the 37-month study.

What Are the Side Effects of Mayzent?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects of Mayzent include:

Severe Side Effects

Call your healthcare provider 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 the following:

  • Bradyarrhythmia (abnormally slow heartbeat) or atrioventricular block
  • Skin cancer
  • Lymphocytopenia (low white blood cells)
  • Infections, such as herpes virus and Cryptococcal meningitis
  • Progressive multifocal leukoencephalopathy (PML)
  • Macular edema
  • Breathing problems and shortness of breath
  • Liver problems 

Long-Term Side Effects

After stopping Mayzent, the drug remains in the bloodstream for 10 days. Lymphocyte counts return to normal in most people within 10 days of stopping the medication but may persist for four weeks after the last dose.

Some people experience a severe increase in disability after stopping S1P receptors, resulting from severe exacerbation of disease or disease rebound. Therefore, you should talk to your healthcare provider before stopping your treatment.

Report Side Effects

Mayzent may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

(800) 332-1088

Dosage: How Much Mayzent Should I Take?

Drug Content Provided and Reviewed byIBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For relapsing forms of multiple sclerosis:
      • Adults—Dose is based on your genotype and must be determined by your doctor.
        • For genotypes *1/*1, *1/*2, or *2/*2—At first, you will need to take this medicine with a 5-day titration schedule with your 12-tablet starter pack. 0.25 milligram (mg) once a day for Days 1 and 2, 0.5 mg (two 0.25 mg tablet) once on Day 3, 0.75 mg (three 0.25 mg tablet) once on Day 4, and 1.25 mg (five 0.25 mg tablet) once on Day 5. Then, a maintenance dose of 2 mg once a day starting on Day 6.
        • For genotypes *1/*3 or *2/*3—At first, you will need to take this medicine with a 4-day titration schedule with your 7-tablet starter pack. 0.25 milligram (mg) once a day for Days 1 and 2, 0.5 mg (two 0.25 mg tablet) once on Day 3, and 0.75 mg (three 0.25 mg tablet) once on Day 4. Then, a maintenance dose of 1 mg once a day starting on Day 5.
      • Children—Use and dose must be determined by your doctor.

Modifications

Safe use of Mayzent in pregnancy has not been established, and there is evidence of potential fetal harm based on animal studies. Use effective contraception while taking Mayzent and 10 days after stopping the medication.  

It is unknown if Mayzent is excreted in human breast milk, and there are no published reports of siponimod use during breastfeeding. However, the expert opinion recommends avoiding this drug during breastfeeding as it is potentially toxic to breastfed infants, especially while nursing a preterm or newborn infant.

Clinical trials of Mayzent did not include enough older adults (aged 65 years and older) to determine if there is a difference in safety or efficacy in this age group. In general, use caution in older adults who may have decreased liver or kidney function.

Missed Dose

If you miss your initial dose of Mayzent or if you miss four or more days in a row during maintenance treatment, you will need to restart the process again from day one. If you miss one dose after the initial dose, take it as soon as you remember.

Overdose: What Happens If I Take Too Much Mayzent?

Overdoses of Mayzent should be treated based on your specific symptoms. Slow heart rate (bradycardia) may occur if you overdose. Your healthcare provider may monitor your symptoms by measuring your pulse and blood pressure and performing electrocardiograms. Although there is no specific treatment for a Mayzent overdose, you may receive atropine or isoprenaline to reverse your bradycardia.

What Happens if I Overdose on Mayzent?

If you think you or someone else may have overdosed on Mayzent, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or stops breathing after taking Mayzent, call 911 immediately.

911

Precautions

Drug Content Provided and Reviewed byIBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 10 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may increase your risk of developing infections, including a herpes infection or a serious brain infection called meningitis or progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma, squamous cell carcinoma). Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

While you are being treated with siponimod, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Do not use this medicine 1 week before and for 4 weeks after receiving a vaccine. Siponimod may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Mayzent?

Do not take Mayzent if you have:

  • A CYP2C9*3/*3 genotype
  • Had a myocardial infarction (heart attack), unstable angina, stroke, transient ischemic attack (TIA), heart failure requiring hospitalization, or Class III/IV heart failure in the last six months
  • Presence of Mobitz Type II second-degree or third-degree atrioventricular (heart) block or sick sinus syndrome without a functioning pacemaker

What Other Medications Interact With Mayzent?

Other medications may interact with Mayzent when taken together. Let your healthcare provider know what medications you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements.

Drugs that may interact with Mayzent include:

  • Antineoplastic (chemotherapy) drugs, such as Campath (alemtuzumab)
  • Immunosuppressants, such as corticosteroids and biologics
  • Other immune-modulating therapies
  • Anti-arrhythmic drugs (e.g., amiodarone, quinidine) and QT-prolonging drugs (e.g., chlorpromazine, haloperidol)
  • Beta-blockers, such as Toprol XL or Lopressor (metoprolol), Tenormin (atenolol), and Hemangeol (propranolol)
  • CYP2C9 and CYP3A4 inhibitors, such as Sporanox (itraconazole), ketoconazole, and grapefruit juice
  • CYP2C9 and CYP3A4 inducers, such as Rimactane (rifampin) and phenobarbital

Antineoplastic, Immunosuppressant, or Immune-modulating Therapies

These drugs may increase the risk of infection when taken with Mayzent due to their additive immunosuppressive effects.

Anti-arrhythmic and QT-prolonging Drugs

Mayzent has not been studied in people taking QT-prolonging drugs. Class IA (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmics can lead to life-threatening arrhythmias in people with bradycardia.

Beta-Blockers

Caution must be used when taking beta-blockers with Mayzent due to additive heart rate lowering effects. As a result, you may need to temporarily stop beta-blockers before starting Mayzent.

CYP2C9 and CYP3A4 Inhibitors

Combining one or more drugs that cause moderate CYP2C9 inhibition and moderate/strong CYP3A4 inhibition increases the exposure to blood levels of siponimod and is not recommended.

CYP2C9 and CYP3A4 Inducers

Combining one or more drugs that cause moderate CYP2C9 induction and strong CYP3A4 induction is not recommended due to a significant decrease in siponimod blood levels and likely loss of therapeutic effect.

People taking Mayzent may also have a reduced immune response to vaccinations. As a result, vaccines may be less effective while taking Mayzent, so pause Mayzent for one week prior and four weeks after vaccination. Likewise, avoid live vaccines while taking Mayzent and for four weeks after stopping Mayzent due to the risk of infection. Live vaccines include:

  • Intranasal flu vaccine
  • Measles, mumps, rubella (MMR) vaccine
  • Rotavirus vaccine

What Medications are Similar?

Mayzent is a sphingosine 1-phosphate (S1P) receptor modulator used for relapsing forms of MS. Other S1P receptor modulators include:

People should only take one S1P receptor modulator at a time.

Frequently Asked Questions

  • How does Mayzent work?

    Mayzent is an S1P receptor modulator that blocks lymphocytes from emerging from lymph nodes, thereby reducing the number of lymphocytes in peripheral circulation. It’s not clear how this drug exerts a therapeutic effect in MS, but it may be related to decreasing lymphocyte migration into the central nervous system.

  • What side effects can I expect while taking Mayzent?

    The most common side effects of Mayzent are headache, high blood pressure, and elevated liver enzymes.

  • How long does it take Mayzent to work?

    In clinical trials, a decrease in disability progression emerged after taking Mayzent for three months. With long-term use, Mayzent also decreases the frequency of relapse compared to placebo.

How Can I Stay Healthy While Taking Mayzent?

Starting a new treatment can be overwhelming, so it is important to talk to your healthcare provider about any questions or concerns you have.

Before starting treatment with Mayzent, your healthcare provider should determine your CYP2C9 genotype by a blood test, as your dose will be based on this. Take Mayzent exactly as prescribed; don't stop your treatment regimen without first discussing it with your healthcare provider.

Mayzent can increase the risk of infections, some of which could be life-threatening. Contact your healthcare provider if you develop symptoms of infection. Keep in mind that the immunosuppressive activity of Mayzent persists for about four weeks after stopping the medication. Other symptoms for which you should seek immediate evaluation by a healthcare provider include:

  • Progressive weakness on one side of the body or clumsiness of limbs
  • Visual disturbances
  • Changes in thinking, memory, or personality
  • Severe headache
  • Unexplained nausea and vomiting
  • Jaundice
  • New or worsening breathing problems

If you are a person of childbearing potential, discuss contraception options with your healthcare provider. Taking Mayzent while pregnant may harm the fetus.

Be sure that your healthcare provider knows all of the medications you are taking. Mayzent has several clinically significant drug interactions that your pharmacist can detect as long as they know your complete medication list. Keep a list to review with your healthcare team when you start a new medication.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). As indicated on the page, IBM Watson Micromedex provides some of the drug content.


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