Mayzent

Mayzent is a prescription medication used to treat multiple sclerosis (MS).

Mayzent belongs to a class of medications known as sphingosine 1-phosphate receptor modulators. This medication works by preventing white blood cells from leaving the lymphnodes and entering the bloodstream.

This medication comes in tablet form and is taken once a day.

Common side effects of Mayzent include headache, high blood pressure and increased liver function tests.

Mayzent is a prescription medication used to treat relapsing forms of multiple sclerosis (MS) in adults, to include: 

• clinically isolated syndrome 
• relapsing-remitting disease 
• active secondary progressive disease 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mayzent. See the "Mayzent Precautions" section.

Common side effects of Mayzent include the following:

• headache
• high blood pressure
• increased liver function tests

This is not a complete list of Mayzent side effects. Ask you doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell you doctor if you take:

• take medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heart beat (such as calcium channel blockers or beta-blockers)
• take medicines that affect your immune system, such as beta-interferon or glatiramer acetate, or any of these medicines that you took in the past
• have recently received a live vaccine. You should avoid receiving live vaccines during treatment with Mayzent. Mayzent should be stopped 1 week before and for 4 weeks after receiving a live vaccine. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with Mayzent.

This is not a complete list of Mayzent drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mayzent including the following:

• Slow heart rate (bradycardia or bradyarrhythmia) when you start taking Mayzent. Mayzent can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of Mayzent. During the initial updosing period (4 days for the 1 mg daily dose or 5 days for the 2 mg daily dose), if you miss 1 or more doses of Mayzent, you need to restart the updosing. Call your healthcare provider if you miss a dose of Mayzent.
• Infections. Mayzent can increase your risk of serious infections that can be life-threatening and cause death. Mayzent lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 to 4 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking Mayzent. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with Mayzent and for 3 to 4 weeks after your last dose of Mayzent:
  • fever
  • tiredness
  • body aches
  • chills
  • nausea
  • vomiting
  • headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)
• A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 1 to 4 months after your start taking Mayzent. Your healthcare provider should test your vision before you start taking Mayzent and any time you notice vision changes during treatment with Mayzent. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Call your healthcare provider right away if you have any of the following:
  • blurriness or shadows in the center of your vision
  • a blind spot in the center of your vision
  • sensitivity to light
  • unusually colored (tinted) vision
• Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with Mayzent.
• Liver problems. Mayzent may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking Mayzent. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • nausea
  • vomiting
  • stomach pain
  • tiredness
  • loss of appetite
  • your skin or the whites of your eyes turn yellow
  • dark urine
• Breathing problems. Some people who take Mayzent have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
• Swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened with drugs in the same class. Symptoms of PRES usually get better when you stop taking Mayzent. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms:
  • sudden severe headache
  • sudden confusion
  • sudden loss of vision or other changes in your vision
  • seizure

Do not take Mayzent if you:

• are pregnant or planning to become pregnant
• have certain results to genotyping (pre-medication genetic testing)
• experienced a heart attack, unstable angina, stroke, TIA ('mini-stroke'), or heart failure in the last 6 months
• have a history of second- or third-degree heart block, or sick sinus syndrome, unless you have a functioning pacemaker

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mayzent, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Mayzent, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have an irregular or abnormal heartbeat
• a history of stroke or other diseases related to blood vessels in the brain
• breathing problems, including during your sleep
• a fever or infection, or you are unable to fight infections due to a disease or taking medicines that lower your immune system. Tell your healthcare provider if you have had chicken pox or have received the vaccine for chicken pox. Your healthcare provider may do a blood test for chicken pox virus. You may need to get the full course of vaccine for chicken pox and then wait 1 month before you start taking Mayzent.
• have slow heart rate
• have liver problems
• have diabetes
• have eye problems, especially an inflammation of the eye called uveitis
• have high blood pressure
• are pregnant or plan to become pregnant. Mayzent may harm your unborn baby. Talk to your healthcare provider right away if you become pregnant while taking Mayzent or if you become pregnant within 10 days after you stop taking Mayzent.
  • If you are a woman who can become pregnant, you should use effective birth control during your treatment with Mayzent and for at least 10 days after you stop taking Mayzent.
• are breastfeeding or plan to breastfeed. It is not known if Mayzent passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mayzent.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

• Mayzent may harm your unborn baby. Talk to your healthcare provider right away if you become pregnant while taking Mayzent or if you become pregnant within 10 days after you stop taking Mayzent.
  • If you are a woman who can become pregnant, you should use effective birth control during your treatment with Mayzent and for at least 10 days after you stop taking Mayzent.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mayzent crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mayzent.

• Take Mayzent exactly as your healthcare provider tells you. Do not change your dose or stop taking Mayzent unless your healthcare provider tells you to.
• Take Mayzent 1 time each day.
• Take Mayzent with or without food.
• If you miss 1 or more doses of Mayzent during the initial dose titration, you need to restart the medication.
• If you miss a dose of Mayzent after the initial dose-titration, take it as soon as you remember.
• If Mayzent treatment is stopped for 4 days in a row, treatment has to be restarted with the titration.
• Do not stop taking Mayzent without talking with your healthcare provider first.

The daily maintenance dose of Mayzent is either 1 mg or 2 mg, depending on your CYP2C9 genotype. Ask your healthcare provider if you are not sure about your daily maintenance dose.
Start your treatment with Mayzent using the following titration (adjusting the dose) schedule:

For the 1 mg daily maintenance dose: 
  Day 1: 1 x 0.25 mg tablet
  Day 2: 1 x 0.25 mg tablet
  Day 3: 2 x 0.25 mg tablet
  Day 4: 3 x 0.25 mg tablet
  Day 5 and every day after: 4 x 0.25 mg tablet

For the 2 mg daily maintenance dose, use the starter pack: 
  Day 1: 1 x 0.25 mg tablet
  Day 2: 1 x 0.25 mg tablet
  Day 3: 2 x 0.25 mg tablet
  Day 4: 3 x 0.25 mg tablet
  Day 5: 5 x 0.25 mg tablet
  Day 6 and every day after: 1 x 2 mg tablet

If you take too much Mayzent, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Before opening:

• Mayzent 0.25 mg and 2 mg tablets should be stored in a refrigerator between 36°F to 46°F (2°C to 8°C).

After opening:

• Mayzent 0.25 mg tablets in the Starter Pack may be stored at room temperature, 68°F to 77°F (20°C to 25°C), for up to 1 week after opening.
• Mayzent 0.25 mg and 2 mg tablets in bottles may be stored at room temperature, 68°F to 77°F (20°C to 25°C), for up to 1 month after opening.

Keep Mayzent and all medicines out of the reach of children.