Have questions about GILENYA? You've come to the right place
Ahhh, questions. You probably have a few (that's why you're here, right?). These are some of the top questions we hear from people who are thinking about starting on GILENYA®. We hope these answers help.
If you don't see what you're looking for, we encourage you to visit the Let's Talk tab on the GILENYA Facebook page. There, you'll find a place to submit your questions, get some answers, and connect with other people living with relapsing multiple sclerosis (MS).
In the 4 years since it was first approved by the FDA, GILENYA has become the most prescribed once-a-day* pill for relapsing MS. It has also been proven effective in people with relapsing MS in 2 key clinical trials.
Let's look at the results. GILENYA was proven in clinical trials to cut relapses in half. People taking GILENYA had 52% fewer MS relapses in a 1-year study vs Avonex®. And in a 2-year study, GILENYA cut relapses by 54% vs placebo.
Still curious? We thought you might be. So we put together more information about the benefits of GILENYA.
Besides the fact that it's the first once-daily* MS pill for relapsing MS, why else might GILENYA be right for me?
- GILENYA was proven in clinical trials to cut MS relapses in half. People taking GILENYA had 52% fewer MS relapses than people taking Avonex in a 1-year study. In the same study, GILENYA also kept 83% of people relapse-free at 1 year compared to 70% of people taking Avonex. Similar results were seen in a 2-year study that compared GILENYA to a placebo, or sugar pill. GILENYA cut relapses by 54% compared to placebo. And 70% of people on GILENYA were relapse-free for 2 years, vs 46% who took placebo
- GILENYA was proven to slow down the physical problems that MS causes. In a 2-year study vs placebo, more than 8 out of 10 people taking GILENYA showed no disability progression.† In other words, 18% of people on GILENYA experienced some form of disability progression, as measured by the EDSS scale. In the same study, 76% of people with relapsing MS taking placebo stayed the same, while 24% showed worsening disability
- In a separate 1-year study, there was no significant difference in disability progression between GILENYA and Avonex†
- GILENYA reduced lesions as seen on MRI. People on GILENYA had fewer lesions vs Avonex in a 1-year study and vs placebo in a 2-year study
- First, let's look at the results of the 1-year study. On average, people taking GILENYA had 38% fewer new or newly enlarging T2‡ lesions compared to people taking Avonex. In the same study, GILENYA cut the average number of Gd+ T1 lesions by 60%
- In the 2-year study, GILENYA reduced the average number of new or newly enlarging T2 lesions. On average, people taking GILENYA had 74% fewer new or newly enlarging T2 lesions compared to people taking placebo. In the same study, GILENYA cut the average number of Gd+ T1 lesions by 82%
I'm curious about GILENYA as a possible relapsing MS treatment. Any tips on how to ask my doctor about it?
As a matter of fact, we've got more than tipswe've got a little something to help you get the ball rolling. Complete this list of questions and bring it with you to your next appointment. It's a good starting point when it comes to talking to your doctor, and it includes things to think about, like why you're interested in GILENYA as a relapsing MS treatment.
Be honesthow many MS relapses have you had? Are you having problems injecting yourself?
Obviously, you and your health care team want the treatment that best helps you manage your relapsing MS. GILENYA might be right for you. Then again, it might not be. But it's always worth asking. Advocate for yourself. Ask questions.
For a few other ideas, tips, and tricks, connect with others living with relapsing MS who are speaking out against their condition.
If GILENYA is a tested and proven relapsing MS treatment, why do I need to be monitored for 6 hours?
GILENYA works differently from other MS treatments. One differenceyour heart rate is expected to slow down the first time you take GILENYA.
This slowdown is usually temporary. For most people, slow heart rate begins to return to normal after 6 hours and usually fully returns to normal within 1 month. Not only that, in clinical trials, less than 1% of people taking GILENYA experienced symptoms of slow heart rate. Whether you're part of this 1% or not, you will still be monitored during your first dose, so it's important for you to understand what's happening.
Why does GILENYA affect your heart? First, let's talk about MS. MS happens when your white blood cellsand other immune cellsmistakenly attack your nervous system.
How does GILENYA help? GILENYA is thought to help by activating certain sensors on your lymph nodes, which keeps some white blood cells in your lymph nodes. That way, these white blood cells aren't released into your bloodstream, where they can attack your nervous system.
GILENYA also activates certain sensors on your heart, which causes your heart rate to slow down. Unlike the sensors on your lymph nodes, the effect on the sensors on your heart is temporary and only happens when you start GILENYA. This slowdown in heart rate is expected, and it's the reason you're monitored during your first dose.
If you're one of the few people who experiences symptoms of slow heart rate (such as dizziness, tiredness, or feeling like your heart is beating slowly or skipping beats), the health care professional monitoring you can help you manage these symptoms.
Symptoms of slow heart rate usually happen within the first 6 hours of your first dose and can happen up to 24 hours after your first dose. To help you start off safely and confidently, we'll make sure your heart rate is monitored by a health care professional for at least these first 6 hours when you take your first dose.
When you take your first dose of GILENYA, it's expected that your heart rate will slow down temporarily. GILENYA has a plan in place to help monitor slow heart rate during your first day on GILENYA. See it in action.
In clinical trials, less than 1% of people taking GILENYA experienced symptoms from slow heart rate. These may include dizziness, tiredness, and feeling like your heart is beating slowly or skipping beats. Symptoms usually happen within the first 6 hours of your first dose and can happen up to 24 hours after your first dose of GILENYA, and are usually temporary.
If you have any serious side effects after your first dose of GILENYA, especially those that require treatment with other medicines, you will stay in the medical facility to be watched overnight. You will also be watched for any serious side effects for at least 6 hours after you take 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 of GILENYA. Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA. It's good to ask questions. It's the only way to weigh the pros and cons and to decide with your health care team if GILENYA is the right MS treatment for you.
This is a smart question (we like people who take charge and get all the answers first). Here are the facts:
Macular edema is a vision problem that can affect your vision and cause some of the same vision symptoms as an MS relapse (optic neuritis). In clinical studies, less than 1% of people taking GILENYA experienced macular edema. For those who did, macular edema usually improved or went away after stopping GILENYA. It's possible that you may not even notice any symptoms, but if macular edema occurs, it usually begins in the first 3 to 4 months after starting GILENYA, so make sure you schedule an eye exam 3 to 4 months after you start taking GILENYA.
Your doctor should test your vision before you start on GILENYA, 3 to 4 months into treatment, or any time you notice vision changes while taking GILENYA. Your risk of macular edema may be higher if you have diabetes or have had an inflammation of your eye called uveitis.
- 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
If you want to know more, check out what to know about GILENYA safety.
Once you've completed your first day, you can take GILENYA as directed by your doctor in the comfort of your own home. One pill, once a day,* taken with water. With or without food. And that's not just on day 2. That's every day, for as long as your doctor has you taking GILENYA.
Want to know what to expect during your first day on GILENYA? Get the scoop here.
- answer your questions about GILENYA
- get you set up for testing and your first dose
- help you figure out your insurance coverage
- and much, much more
I've heard that most eligible people paid a $0 prescription co-pay for GILENYA.|| How do I know if I'm eligible?
You've heard right! Most eligible people paid a $0 prescription co-pay for GILENYA.|| How to know if you're eligible? Once your doctor submits the form to start GILENYA, the GILENYA Care Team will check your existing insurance coverage and call you to explain how to get the most from your benefits. GILENYA has co-pay support programs that can help.
Want to know more? We thought you might. That's why we created an entire page about paying for GILENYA.
We certainly didn't mean to leave you hanging! If you're not finding the info you need online, there are a few different things you can do.
First, you can attend a GILENYA online meetup, which happen every Tuesday and Thursday evening. This is where a doctor and a real person taking GILENYA share their experiences and then open up the floor for questions. Whether you have a medical question or are simply wondering what it's like to be on GILENYA, these are the people to ask!
Second, you can get in touch with one of our Novartis GILENYA Nurses (once your doctor sends us the form to get started). They're experts on all things GILENYA, and are available to answer questions you may havefrom how GILENYA works to how to get started. Give them a call at 1-800-GILENYA (1-800-445-3692), 8:00 AM9:00 PM ET, MonFri.§
And third, you can ask your doctor. He or she knows you best and can help you find the answers you're looking for. Check out these suggestions to get the conversation started.