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Overview: Mayzent is commonly used to treat multiple sclerosis. It targets a type of lymphocyte (a type of white blood cell) to reduce the frequency of multiple sclerosis relapses. Common side effects include headache, high blood pressure, and changes in liver function tests.

Uses

What is Mayzent used for?

Mayzent (siponimod) is commonly used to treat multiple sclerosis (MS). MS is a chronic condition where the immune system attacks and damages the protective coating around nerve cells, making it harder for the brain and body to work together. This can cause symptoms like trouble walking, fatigue, muscle weakness, numbness, and vision and memory problems. Mayzent can treat the following relapsing forms of MS. 

  • Clinically isolated syndrome (CIS)
  • Relapsing-remitting MS (RRMS)
  • Active secondary progressive MS (SPMS)

Mayzent may also be used for other conditions as determined by your health care provider.

How does Mayzent work (mechanism of action)?

Mayzent works by targeting immune cells called lymphocytes. These cells play a key role in the inflammatory process in the central nervous system. Mayzent helps reduce the frequency of multiple sclerosis relapses. 

How is Mayzent supplied (dosage forms)?

Brands and other names

  • Mayzent

Dosage forms and strengths

  • 0.25 mg, 1 mg, 2 mg oral tablets

How should I store Mayzent?

Unopened Bottle. Mayzent should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. It can be stored this way for up to three months. If you need to store your unopened bottle for more than three months, keep it in a refrigerator between 36 F and 46 F (2 to 8 C) until you need to use it.

Opened Bottle. Mayzent should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. It can be stored this way for up to three months. Do not put the medicine in the refrigerator after you open the bottle.

Starter Pack/Blister Card. Mayzent should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not refrigerate after opening. Store Mayzent in the original container provided.

Side Effects

What are the most common side effects of Mayzent?

The most common side effects of Mayzent are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Increased blood pressure (see below)
  • Liver damage (see below)

There may be other side effects of Mayzent that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Mayzent?

While less common, the most serious side effects of Mayzent are described below, along with what to do if they happen.

Severe Allergic Reactions. Mayzent may cause allergic reactions, which can be serious. Stop taking Mayzent and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Mayzent can increase the risk of infection, including serious infections that can be life-threatening. This risk can last up to four weeks after you stop taking Mayzent. Your health care provider will check your white blood cell levels before and during treatment. Call your health care provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Headache and a stiff neck, with fever, light sensitivity, nausea, or confusion (may be symptoms of an infection of the lining around your brain and spine)

Heart Rate Changes. When you start taking Mayzent, especially after the first dose, your heart rate may be slower than normal (bradycardia). You will have an electrocardiogram (EKG or ECG) before starting therapy. This is a common test to monitor the rate and rhythm of your heart. Call your health care provider right away if you have any of the following symptoms of bradycardia.

  • Feeling lightheaded, dizziness, or fainting
  • Confusion
  • Feeling weak or easily tired
  • Chest pain
  • Shortness of breath
  • Feeling your heart beat slower or skipping a beat

Progressive Multifocal Leukoencephalopathy (PML). People taking Mayzent may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop taking Mayzent and call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness, loss of coordination, or balance problems
  • Decreased strength
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Confusion
  • Weakness on one side of your body that gets worse
  • Seizures

Vision Problems. Mayzent may increase your risk of macular edema. Macular edema happens when fluid builds up in the back of your eye. People with eye inflammation (uveitis) or diabetes may have a higher risk of macular edema while taking Mayzent. Keep any scheduled eye exams before starting or while taking Mayzent. Call your health care provider right away if you have any of the following symptoms of macular edema.

  • Blurriness or shadows 
  • Sensitivity to light
  • Worsening vision
  • A blind spot in the middle of your vision
  • Dull or unusually colored or tinted vision

Increased Blood Pressure (Hypertension). Mayzent may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Mayzent. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Breathing Problems. Mayzent may cause shortness of breath (dyspnea), which can be serious. Call your health care provider right away if you have new or worsening breathing problems.

Posterior Reversible Encephalopathy Syndrome (PRES). Mayzent may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision 
  • Sudden severe headache
  • Seizures

Severe Worsening of Multiple Sclerosis Symptoms After Stopping Treatment. When stopping Mayzent, symptoms of multiple sclerosis (MS) may return. These symptoms may be worse than they were before or during treatment with Mayzent. Do not stop taking Mayzent unless directed by your health care provider. Call your health care provider if your MS symptoms worsen after you stop taking Mayzent. 

Skin Cancer. Mayzent may increase your risk of skin cancer, such as basal cell carcinoma, melanoma, and squamous cell carcinoma. Limit the amount of time you spend in the sun while taking Mayzent. Wear protective clothing and use sunscreen with a high sun protection factor. Keep any appointments to have your skin checked while taking Mayzent. Tell your health care provider if you notice any of the following symptoms of skin cancer.

  • Changes in a mole on your skin
  • A new darkened area on your skin
  • A sore that does not heal
  • Growths on your skin, such as a bump

Warnings & Precautions

Who should not use Mayzent?

Allergies to Ingredients. People who are allergic to any of the following should not take Mayzent.

  • Mayzent
  • Siponimod
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Mayzent.

Heart Problems. You should not take Mayzent if you have certain heart rhythm problems unless you have a working pacemaker. You should not take Mayzent if you have had any of the following heart problems in the last six months.

Genetics. You should not take Mayzent if you have a specific gene variation called CYP2C9*3/*3. This gene helps the body process the medicine, and if you have this gene variation, your body may process Mayzent too slowly, which could lead to serious side effects. Your health care provider will test you for this variation before you take Mayzent.

What should I know about Mayzent before using it?

Do not take Mayzent unless it has been prescribed to you by a health care provider. Take it as prescribed. Your treatment will begin with a four- or five-day titration. You will gradually increase the dose over this time until you get to your maintenance dose.

Do not share Mayzent with other people, even if they have the same condition as you. It may harm them.

Keep Mayzent out of the reach of children.

Swallow the tablet whole. Do not chew, crush, or split the tablet. If you have trouble swallowing this medicine, call your health care provider.

Before you start taking Mayzent, your health care provider will check your heart rate. If you have a slow heart rate or certain heart conditions, you may need to be observed in a hospital or clinic for about six hours after you take your first dose. Tell your health care provider about any heart conditions you have.

Your health care provider will order blood tests before and during treatment with Mayzent. Keep all appointments for follow up and blood tests.

Do not stop taking Mayzent without talking to your health care provider. When Mayzent is stopped, your multiple sclerosis symptoms may return and be worse than before starting treatment. If your symptoms become worse, talk with your health care provider.

What should I tell my health care provider before using Mayzent?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Mayzent is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Irregular or abnormal heartbeat
  • Slow heart rate
  • History of stroke or other blood vessel conditions
  • Fever, infection, or a weak immune system
  • Breathing problems, including during sleep (sleep apnea)
  • Chickenpox infection or have received the chickenpox vaccine
  • Liver problems
  • Diabetes
  • Eye problems, such as inflammation of the eye (uveitis)
  • High blood pressure
  • Skin cancer, including basal cell carcinoma, melanoma, or squamous cell carcinoma

Other Medicines and Supplements. Mayzent may interact with other medicines and supplements. Before taking Mayzent, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before, while taking Mayzent, and for four weeks after stopping treatment. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. Mayzent may harm your fetus. Tell your health care provider if you are or plan to become pregnant, or if you become pregnant while taking Mayzent or within 10 days of your last dose. You should use effective birth control while taking Mayzent and for at least 10 days after the last dose. You can talk to your health care provider about the best type of birth control for you. If you get pregnant while taking Mayzent, you can sign up for the MotherToBaby Pregnancy Study in Multiple Sclerosis by calling 877-311-8972 or by visiting www.mothertobaby.org/join-study. This registry collects safety information about taking Mayzent during pregnancy.

Breastfeeding. It is not known if Mayzent passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take Mayzent while breastfeeding.

How can I get more information about Mayzent?

For more information about Mayzent, you can visit the drugmaker’s website at www.mayzent.com or call them at 888-669-6682.

Interactions

Does Mayzent interact with foods or drinks?

There are no known interactions between Mayzent and foods or drinks.

It is unknown if drinking alcohol will affect Mayzent, but both Mayzent and alcohol can cause liver damage. It is likely best to limit the amount of alcohol you drink while taking Mayzent.

Does Mayzent interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Mayzent.

  • Alemtuzumab (Campath, Lemtrada), which is a medicine used to treat multiple sclerosis or a certain type of cancer
  • Any cancer medicines
  • Any medicines that affect the immune system, such as beta interferon (Betaseron and others) or glatiramer acetate (Copaxone, Glatopa) 
  • A medicine used for an irregular heart rhythm, such as amiodarone (Pacerone and others), procainamide, quinidine, or sotalol (Betapace)
  • A calcium channel blocker, such as diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
  • A beta-blocker, such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL, and others), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to lower blood pressure
  • Ivabradine (Corlanor), which is a medicine used for heart failure
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Fluconazole (Diflucan), which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Modafinil (Provigil), which is a medicine used for excessive sleepiness due to narcolepsy or other conditions
  • Efavirenz, which is a medicine used for HIV

Some other medicines may alter the blood levels of Mayzent. Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Mayzent. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Mayzent?

If you or someone else has used too much Mayzent, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Mayzent?

If you miss a dose of Mayzent during the initial updosing period, you will need to restart the medicine. After the initial updosing period, if you miss a dose, take it as soon as you remember. If you miss a dose for four days in a row, you will need to restart the medicine with the titration. Call your health care provider if you miss a dose of Mayzent.

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