Have questions? Here are some answers
Ahhh, questions. You probably have a few (that's why you're here, right?). Here are some of the main questions we hear from people thinking about starting on GILENYA®. We hope these help.
If you don't see what you're looking for, we encourage you to check out our Facebook page. There, you'll find a place to submit your questions, get some answers, and connect with others like you. And stay tuned: we're going to keep adding answers here as we hear more from people just like you.
YOU SAY GILENYA IS EFFECTIVE. WHERE'S THE PROOF?
GILENYA was tested in two key clinical trials, with thousands of people. Here's a bit more info:
Only GILENYA combines proven efficacy to cut multiple sclerosis (MS) relapses in half vs Avonex®, in the first once-daily* pill. GILENYA reduced the frequency of relapses by 52% in a 1-year study vs Avonex, and by 54% in a 2-year study vs placebo.
GILENYA was approved in the United States on September 21, 2010 to treat relapsing forms of MS.
Still curious? We thought you might be. So we put together more information for you. Click here.
BESIDES THE FACT THAT IT'S THE FIRST ONCE-DAILY* PILL FOR RELAPSING FORMS OF MS, WHAT MAKES GILENYA WORTH TAKING?
GILENYA has shown results. Here are a few:
- It's been proven to cut MS relapses in half. GILENYA reduced the frequency of relapses by 52% in a 1-year study vs Avonex, and by 54% in a 2-year study vs placebo
- It's been shown to help slow down disability progression. After 2 years, people taking GILENYA were 30% less likely to have physical disability progression (18% of people taking GILENYA had disability scores that got worse vs 24% on placebo). In a separate 1-year study, there was no significant difference in disability progression between GILENYA and Avonex
- It kept many people relapse-free. At the 1-year mark in a clinical trial, 83% of people on GILENYA were relapse-free. Of those people taking Avonex instead, 70% were relapse-free at year's end. In a separate study, 70% of people on GILENYA were relapse-free for the entire 2 years. For the people taking placebo during that time, 46% of them stayed relapse-free.
- It's been shown to decrease the number of lesions on MRI. GILENYA also reduced the average number of new or newly enlarged T2 lesions, and reduced the average number of T1 Gd+ lesions. Here are the details:
- In a 1-year study, the average number of new or newly enlarged T2† lesions was 1.6 with GILENYA vs 2.6 with Avonex; and in a 2-year study, 2.5 with GILENYA vs 9.8 with placebo
- Now, let's talk Gd+ T1† lesions. In a 1-year study, the average number of Gd+ T1† lesions was 0.2 with GILENYA vs 0.5 with Avonex; and in a 2-year study, 0.2 with GILENYA vs 1.1 with placebo
Thousands of people have already done their research and discussed GILENYA with their doctor and health care team.
I'M CURIOUS ABOUT GILENYA. ANY TIPS ON HOW TO ASK ABOUT IT?
As a matter of fact, we've got more than tips—we've got a little something to help you get the ball rolling. Complete this list of questions, and bring them with you to your next appointment. They're a good starting point when it comes to talking to your doctor, and include things to think about, like why you're interested in GILENYA. Be honest—how many relapses have you had? Are you having problems injecting yourself? Are you tired of painful injection site reactions? That's another thing worth discussing.
Obviously, you and your health care team want a therapy that helps you manage your relapsing MS. GILENYA might be just right for you. Then again, it might not. But it's always worth asking. Advocate for yourself. Ask questions and follow-up questions.
For a few other ideas, tips, and tricks, listen to people like you who are taking a stance against their relapsing MS.
IF GILENYA IS TESTED AND PROVEN, WHY DO I NEED TO BE MONITORED FOR 6 HOURS?
Safety's no trivial matter. That's why everyone takes their first dose where they can be monitored by a health care team. The first time you take GILENYA, your pulse and blood pressure will be checked every hour over a 6-hour period. That's because heart rates usually reach the lowest levels within this time. This decrease is expected and usually doesn't last a long time. In fact, for most people, heart rates begin to return to normal within 6 hours, and usually fully return to normal within 1 month.
Want to know more about what to expect on your first day? Get the scoop here.
I'VE HEARD GILENYA MIGHT CAUSE POSSIBLE HEART PROBLEMS. IS THIS TRUE?
Good question. Here's the deal:
Some people may experience symptoms due to slow heart rate. That's why your doctor and health care team will watch you in a medical facility for at least 6 hours when you take your first dose, and you will have a test to check the electrical activity of your heart (ECG). It's the best way to make sure you're starting off with no major issues.
If your heart rate slows down too much, you may have symptoms such as dizziness, tiredness, or feeling like your heart is beating slowly or skipping beats. If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of GILENYA. Symptoms can happen up to 24 hours after you take your first GILENYA dose.
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 these 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 choice for you.
Still curious? We thought you might be. So we put together more information for you right here.
SOMEONE TOLD ME GILENYA MIGHT CAUSE A VISION PROBLEM. WHAT DO YOU SAY ABOUT THAT?
Another smart question (we like people who take charge and get all the answers first). Here are the facts:
Some people may experience a vision problem called macular edema. Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms with macular edema. Macular edema usually starts in the first 3 to 4 months after you start taking GILENYA.
Your doctor should test your vision before you start on GILENYA, and 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.
Call your doctor 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
If you want to know more, click here.
IF I GET THE GREEN LIGHT FROM MY DOCTOR AND I START GILENYA, WHAT HAPPENS ON DAY TWO?
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.
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 you submit the form to get started on 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.