HERE'S WHAT YOU NEED TO KNOW ABOUT THE SAFETY
OF MAYZENT
Before starting any new medication, it’s important to consider possible side effects. Keep in mind that everyone reacts to medications differently. The only way to determine if MAYZENT is right for you is by talking with your doctor. Here are some serious side effects and the most common side effects that occurred in the core MAYZENT clinical study. Additionally, the safety of MAYZENT was studied and shown to be consistent for up to 5 years in an ongoing, open-label* extension study.
*A type of study where participants are aware of the type of treatment they're being given. Interpreting results from open-label studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.
SELECT SERIOUS SIDE EFFECTS OF MAYZENT
SLOW HEART RATE
(bradycardia or
bradyarrhythmia)
MAYZENT may 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.
INFECTIONS
MAYZENT lowers the number of white blood cells (lymphocytes)
in your blood, which may increase
your
risk of serious infections that can be life-threatening or
cause death. This will usually go back to
normal within 3 to 4 weeks of
stopping treatment. Your health care provider should review a
recent
blood test of your white
blood cells before you start treatment.
Progressive multifocal leukoencephalopathy (PML)
MAYZENT may increase your risk for PML, which is a rare brain
infection that may lead to death
or severe disability. If PML
happens, it usually happens in people with weakened immune
systems
but has happened in people who do not have weakened
immune systems. Symptoms of PML get
worse over days to
weeks.
MACULAR EDEMA
MAYZENT may cause macular edema, a buildup of fluid in the eyes that can occur with or without
visual symptoms. If macular edema happens, it usually starts within the first 1 to 4 months after
you begin treatment. Your health care provider should test your vision before you start MAYZENT
and any time you notice vision changes during treatment. Your risk of macular edema is higher if
you have diabetes or have had an inflammation of your eye called uveitis.
THE MOST COMMON SIDE EFFECTS OF MAYZENT
MAYZENT
Placebo
Headache
15%
14%
High blood
pressure
13%
9%
Abnormal
liver test
11%
3%
Other common side effects included falls, limb swelling, nausea, dizziness, diarrhea, slowed heart rate, and limb pain.
These are not all of the possible side effects of MAYZENT. To see more information about safety, including all possible side effects of MAYZENT, please see the full Prescribing Information, including Medication Guide.
INFORMATION ABOUT TAKING MAYZENT AND COVID-19
Your safety is our highest priority, which is why we are committed to keeping our MS community updated with the latest information. Please see our COVID FAQ section for more information.
SAFETY ASSESSED IN AN ONGOING EXTENSION STUDY
After the initial 3-year clinical study, people taking MAYZENT had the opportunity to continue
on MAYZENT, while people taking a placebo could choose to switch to MAYZENT. Everyone
who continued taking MAYZENT beyond 3 years were counted in an ongoing, open-label†
extension study for up to five years. The safety profile for these people remained
consistent with the original study, as defined by the incidence of side effects.
†A type of study where participants are aware of the type of treatment they’re being given. Interpreting results from open-label
studies can be uncertain. They are not considered representative results, since participants chose whether to stay in the trial.
“After discussing the side effects, my physician and I decided that
MAYZENT
would be a good option for me, and so that's why we
went with MAYZENT.”
JAMYE P.,
MAYZENT Patient
Individual results may vary.
MS, multiple sclerosis; RMS, relapsing MS.
PROVEN TO SLOW PROGRESSION
Learn how MAYZENT can help people with RMS delay disability progression.
TAKING ONCE-DAILY MAYZENT
See the 2 steps you need to take in order to get started on MAYZENT.