GILENYA. Proven to significantly reduce the
GILENYA reduced the number of relapses
by 52% in a 1-year study versus interferon
beta-1a IM. In fact, 83% of people taking
GILENYA remained relapse-free versus 70%
taking interferon beta-1a IM.
GILENYA was also proven effective in a
separate 2-year study versus placebo.
Indication
GILENYA is a prescription medicine used to
treat relapsing forms of multiple sclerosis (MS)
in adults. GILENYA can decrease the number
of MS flare-ups (relapses). GILENYA does not
cure MS, but it can help slow down the physical
problems that MS causes.
Important Safety Information
You should not take GILENYA if in the last 6 months
you experienced heart attack, unstable angina,
stroke or warning stroke, or certain types of
heart failure. Do not take GILENYA if you have
certain types of an irregular or abnormal heartbeat
(arrhythmia), including a heart finding called
prolonged QT, as seen on a test to check the
electrical activity of your heart (ECG) before starting
GILENYA. You should not take GILENYA if you take
certain medicines that change your heart rhythm.
GILENYA may cause serious side effects such as:
• Slow heart rate, especially after your first dose.
An ECG will be performed before and 6 hours
after your first dose. Your pulse and blood
pressure should be checked every hour while
you stay in a medical facility during this time. If
your heart rate slows down too much, you might
feel dizzy or tired, or feel like your heart is beating
slowly or skipping beats. Symptoms can happen
up to 24 hours after your first dose. After 6 hours,
if your ECG shows any heart problems or if your
heart rate is still too low or continues to decrease,
you will continue to be watched by a health care
professional. If you have any serious side effects
after your first dose, especially those that require
treatment with other medicines, you will stay in a
medical facility to be watched overnight and for
at least 6 hours after your second dose of GILENYA
the next day. If you have certain types of heart
problems, or if you are taking certain types of
medicines that can affect your heart, you will be
watched overnight after you take your first dose.
If you experience slow heart rate, it will usually
return to normal within 1 month. Call your doctor
or go to the nearest emergency room right away
if you have any symptoms of a slow heart rate. If
you stop taking GILENYA for more than 14 days
after your first month of treatment, you will need
to repeat this observation.
