You should not use Mayzent if you have a serious heart condition such as "AV block," sick sinus syndrome and no pacemaker, or if you've recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.
Mayzent can slow your heart rate when you start taking it. You will receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may also need to restart Mayzent under medical observation.
You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, increased sensitivity to light, or problems with coordination, thought, vision, or muscle movement.
Before taking this medicine
You should not use Mayzent if you are allergic to siponimod, or if you have certain serious heart conditions, especially:
"AV block" (2nd or 3rd degree);
sick sinus syndrome (unless you have a pacemaker);
recent (within the past 6 months) heart failure, heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.
Mayzent is not approved for use by anyone younger than 18 years old.
Some heart rhythm medications can cause unwanted or dangerous effects when used with siponimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.
Before you take Mayzent, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking Mayzent.
To make sure Mayzent is safe for you, tell your doctor if you have ever had:
weak immune system (caused by disease or by using certain medicine);
an active or chronic infection;
a very slow heart rate;
high blood pressure;
heart problems, a heart attack, a stroke, or chest pain;
asthma, sleep apnea, or other breathing disorder;
diabetes;
liver disease; or
an eye condition called uveitis.
Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.
Siponimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 10 days after your last dose. Tell your doctor if you become pregnant during this time.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of siponimod on the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I take Mayzent?
Take Mayzent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Your doctor will check your heart function before you start taking Mayzent.
Your dose will be increased gradually during the first 5 to 6 days of taking Mayzent.
Siponimod can slow your heart rate when you start taking it. You will receive your first dose in a medical setting. Your blood pressure and heart rate may be constantly monitored for at least 6 hours after your first dose of Mayzent.
You may take Mayzent with or without food.
Siponimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last 3 to 4 weeks after you stop taking this medicine.
Always ask your doctor before you stop taking Mayzent for any reason. When you stop taking this medicine, your MS symptoms may return. In rare cases, some people who stopped taking Mayzent had MS symptoms that were worse than before or during treatment with this medicine.
If you stop taking this medicine, do not start taking it again without asking your doctor. You will need to be under medical observation when you restart this medication.
Store unopened Mayzent in the refrigerator, do not freeze.
After opening, store the medicine in the original package at room temperature away from moisture and heat.
You may keep the blister (Starter) pack at room temperature for up to 1 week after removing the first tablet.
You may keep the bottle of tablets at room temperature for up to 1 month after opening.
If you stop taking Mayzent, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.
