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What is Gilenya®?

Benefits of GILENYA

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Frequently Asked Questions

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 where we have even more interesting stuff about GILENYA. 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?

There's quite a lot, actually. GILENYA was tested in two key clinical trials, with thousands of people. Some facts for you:

Only GILENYA combines proven efficacy to cut multiple sclerosis (MS) relapses in half vs a leading injectable in the first once-daily* pill. GILENYA reduced the frequency of relapses by 52% in a 1-year study vs interferon beta-1a IM, and 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. Today, more than 28,000 people in the United States alone have been prescribed GILENYA.

Still curious? We thought you might be. So we put together more information for you. Click here.

I'VE HEARD GILENYA MIGHT CAUSE POSSIBLE HEART PROBLEMS. IS THIS TRUE?

Good question. Here's the deal:

It's fairly common for you to experience slow heart rate, especially after you take your first dose. 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 right.

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:

It isn't common, but some people experience a vision problem called macular edema. This can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms, but if macular edema occurs, it usually begins in the first 3 to 4 months after starting 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.

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 interferon beta-1a IM, and 54% in a 2-year study vs placebo
  • It's been shown to 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 between GILENYA and interferon beta-1a IM
  • It's been shown to decrease the relapse rate in relapsing forms of MS
  • 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

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?

It's pretty easy. Just speak to your doctor: talk about why you're interested in GILENYA and discuss your situation. 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 with GILENYA.

IF GILENYA IS TESTED AND PROVEN, WHY DO I NEED TO BE MONITORED FOR 6 HOURS?

As mentioned, you'll receive your first dose in a medical facility, and you'll be watched for at least 6 hours. The reason is simple: it's the best way to start right, and to make sure that if you experience symptoms due to slow heart rate, you are under the care of a professional who can help.

Remember: Most people do not experience symptoms due to slow heart rate. But because it is common to have a decrease in heart rate with the first dose, taking it in a medical facility makes sense.

OK, SO I START GILENYA. I START OFF RIGHT, WITH NO MAJOR ISSUES. WHAT HAPPENS ON DAY TWO?

Pretty easy. You can now just 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.

CAN I AFFORD GILENYA? WILL MY INSURANCE COVER THIS?

More good news: prescription and medical co-pay support is available if you are eligible. GILENYA has a $0 co-pay for most eligible people. In fact, the co-pay for GILENYA may be covered for up to $12,000 per year, with no monthly cap, regardless of income level or medical history.

How much support you receive is based on your co-pay amount. Not all patients will receive a $12,000 annual benefit. If you're covered by Medicare, Medicaid, or if you don't have insurance, the GILENYA® Go ProgramTM can still help you maximize your existing benefits, or research potential alternative sources of funding if you need them.

We can get more specific with you if you like. Click here for details or to speak with a GILENYA Navigator.

*GILENYA can result in a slow heart rate when first taken. Your first dose will be given in a medical facility where you will be watched for at least 6 hours. If you stop taking GILENYA for more than 14 days after your first month of treatment, you will need to repeat this observation.

In 2011, 98% of transactions for eligible patients in commercial plans had a $0 co-pay. People for whom GILENYA has been prescribed are required to report any benefits they receive through the GILENYA Prescription Co-Pay Support Program to their insurance company. This offer is not valid for prescriptions for which payment may be made in whole or in part under federal or state health programs, including but not limited to Medicare or Medicaid. This program is subject to termination or modification at any time.

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For relapsing forms of multiple sclerosis (MS)

 
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