About Relapsing Multiple Sclerosis

ALWAYS GET THE FACTS. There's a lot of good information here, so explore!-JuJuan M.

Know thy enemy. Get the facts on relapsing multiple sclerosis (MS)

Odds are, if you're visiting this website and are considering GILENYA® treatment, then you probably already know a thing or two about relapsing multiple sclerosis. But for those of you who may be recently diagnosed (or those just looking for a refresher), this page will give you the basics.

What is relapsing multiple sclerosis?

Relapsing multiple sclerosis is thought to be a chronic autoimmune disease—a type of condition in which your immune system mistakenly attacks healthy body tissue. With MS, the tissues that come under attack are in the body's central nervous system (CNS), which is made up of the brain, spinal cord, and nerve fibers to the eyes.

However, the cause of this attack is unknown. In MS, some white blood cells, called lymphocytes, gain access to the brain. Along with macrophages (another type of white blood cell) and other immune cells, they are believed to mistakenly cause damage to nerve fibers. When the covering of these nerve fibers (called myelin) is damaged or destroyed, nerve impulses from the brain to the rest of the body can get interrupted. This is thought to be the underlying cause of many relapsing MS symptoms.

According to the National Multiple Sclerosis Society (NMSS), relapsing-remitting MS—the most common disease course—is characterized by clearly defined attacks of worsening neurologic function. These attacks (also called relapses, flare-ups, or exacerbations) are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely and there is no apparent progression of disease.

Symptoms of relapsing multiple sclerosis

Everyone experiences relapsing multiple sclerosis symptoms differently and in different combinations. One person may experience numbness or vision problems, while another may feel pain or have difficulty walking.

MS symptoms can also change over time, so what a person experiences in the early stages of the disease may differ from late-stage symptoms. Some symptoms can sometimes disappear, while others may become permanent.

Here's a list of some of the more common symptoms of relapsing MS. Because the condition is so variable, it's not a complete list. So be sure to speak up and tell your health care professional if you notice anything different or unusual.

  • Feeling dizzy or losing your balance
  • Problems with vision
  • Numbness, tingling, or pain
  • Muscle weakness or tremors
  • Trouble walking
  • Bladder issues
  • Depression
  • Feeling tired or fatigued
  • Finding it hard to concentrate or remember things

Who gets multiple sclerosis?

It's hard to believe, but in this day and age, we still don't know the exact cause of multiple sclerosis. However, decades of clinical research have given us a lot of really good leads. Scientists now believe that several underlying risk factors may be associated with MS, including gender, genetics, ethnicity, exposure to certain viruses, and the environment. Here's what we know:

  • Gender: MS is at least 2 to 3 times more common in women than in men
  • Genetics: If you have a family member (eg, a parent, sibling, or child) who has MS, your risk for developing the disease increases. Generally speaking, the risk of developing MS for most people is 1 out of 750. However, if you have a family member with MS, your risk increases to 1 out of 40. The risk may increase more if you have multiple family members with MS, or if you have an identical twin with MS
  • Ethnicity: MS occurs in most ethnic groups, including Caucasians, African-Americans, Asians, and Hispanics/Latinos. While it is most commonly seen in Caucasians of northern European ancestry, new research shows that African-American women may be especially at risk. Findings such as these suggest that ethnicity may be one of several contributing factors
  • Viruses: Some scientists think that certain viruses may trigger MS
  • Environment: MS is less common in areas closer to the equator. These areas receive more sunlight, and because sunlight helps the body produce vitamin D, researchers have looked into the role that vitamin D plays in MS

What can you do to treat relapsing multiple sclerosis?

Plenty! While there is no cure for relapsing MS, we certainly are able to treat it. Spend some time with us on gilenya.com and learn about GILENYA—a once-a-day pill that's proven to treat relapsing MS in ways that matter. You can also hear from real people with relapsing MS who refuse to let their condition push them around.

*Most prescribed 2010 to July 2019.

GILENYA can result in a slow heart rate when first taken. You will be observed by a health care professional for at least 6 hours after you take your first dose. You may need to repeat this monitoring if you miss a dose or are a child who is moving to 0.5 mg from the 0.25 mg dose.

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Dr. David Rintell on life after diagnosis

INDICATION

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

IMPORTANT SAFETY INFORMATION

You should not take GILENYA if in the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure. Do not take GILENYA if you have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm. Do not take GILENYA if you are allergic to fingolimod or any of the other ingredients.

GILENYA may cause serious side effects such as:

  • Slow heart rate, especially after first dose. Adults and children will be monitored by a health care professional for at least 6 hours after the first dose or after a child takes the first dose of 0.5mg of GILENYA when switching from 0.25mg daily dose. Your pulse and blood pressure will be checked hourly. You'll get an ECG before and 6 hours after your first dose. If any heart problems arise or your heart rate is still low, you'll continue to be monitored. If you have any serious side effects, especially those that require treatment with other medicines, or if you have certain types of heart problems, or if you're taking medicines that can affect your heart, you'll be watched overnight. If you experience slow heart rate, it will usually return to normal within 1 month. Call your doctor, or seek immediate medical attention if you have any symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain. Symptoms can happen up to 24 hours after the first dose. Call your doctor if you miss 1 or more doses of GILENYA—you may need to repeat the 6-hour monitoring.
  • Increased risk of serious infections, some of which could be life threatening and cause death. You should not receive live vaccines during treatment with GILENYA and for 2 months after you stop taking GILENYA. Vaccines may not work as well when given during treatment with GILENYA. GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping GILENYA. Your doctor may do a blood test to check your white blood cells before you start GILENYA. Call your doctor right away if, while taking GILENYA or for 2 months after your last dose, you have fever, tiredness, body aches, chills, nausea, vomiting, or headache accompanied by fever, neck stiffness, sensitivity to light, nausea, and/or confusion. These may be symptoms of meningitis.
  • Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads 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. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including changes in your thinking or memory, changes in your vision, decreased strength, problems with balance, weakness on 1 side of your body, loss of coordination in your arms and legs, confusion, or changes in your personality.
  • Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack (optic neuritis), or no symptoms. If it happens, macular edema usually starts in the first 3 to 4 months after starting GILENYA. Your doctor should test your vision before you start GILENYA, 3 to 4 months after you start GILENYA, and any time you notice vision changes. Vision problems may continue after macular edema has gone away. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye (uveitis). Call your doctor right away if you have blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; or unusually colored vision.
  • Swelling and narrowing of the blood vessels in your brain. A condition called PRES (posterior reversible encephalopathy syndrome) has happened rarely in adults taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated, it may lead to a stroke. Call your doctor right away if you experience any symptoms, such as sudden severe headache, sudden confusion, seizures, or sudden loss of vision.
  • Liver damage. Your doctor should do blood tests to check your liver before you start GILENYA and periodically during treatment. Call your doctor right away if you have nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or if your skin or the whites of your eyes turn yellow.
  • Breathing problems. Some patients have shortness of breath. Call your doctor right away if you have trouble breathing.
  • Severe worsening of MS after stopping GILENYA. Many people who have worsening of MS symptoms after stopping GILENYA do not return to the level of function that they had before or during treatment with GILENYA. This can also occur in women stopping due to pregnancy or planning a pregnancy. This worsening happens most often within 12 weeks after stopping GILENYA, but can happen later. Do not stop taking GILENYA without talking with your doctor. Tell your doctor if you have worsening symptoms of MS after stopping GILENYA.
  • Increases in blood pressure (BP). BP should be monitored during treatment.
  • Cancers including basal and Merkel cell carcinoma and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, new darkened area in your skin, a sore that does not heal, or growths on your skin such as a bump that may be shiny, pearly white, skin colored, or pink. While taking GILENYA, limit the amount of time you spend in sunlight and ultraviolet (UV) light as well as use sunscreen with a high sun protection factor and wear protective clothing. Lymphoma has also occurred in patients receiving GILENYA.

GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant. Women who can become pregnant should use effective birth control while on GILENYA, and for at least 2 months after stopping. If you become pregnant while taking GILENYA, or within 2 months after stopping, tell your doctor right away. It is not known if GILENYA passes into breast milk. Talk to your doctor about the best way to feed your baby if you take GILENYA. A pregnancy registry is available for women who become pregnant during GILENYA treatment. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by e-mailing gpr@quintiles.com, or by going to www.gilenyapregnancyregistry.com.

Tell your doctor about all your medical conditions, including if you had or now have an irregular or abnormal heartbeat; stroke or mini-stroke; heart problems; a history of repeated fainting; a fever or infection, or if you are unable to fight infections due to a disease or are taking medicines that lower your immune system, including corticosteroids, or have taken them in the past; eye problems; diabetes; breathing or liver problems; or uncontrolled high blood pressure. Also tell your doctor if you have had chicken pox or have received the chicken pox vaccine. Your doctor may test for the chicken pox virus, and you may need to get the full course of the chicken pox vaccine and wait 1 month before starting GILENYA. Children 10 years and older should complete their vaccination schedule before starting GILENYA.

If you take too much GILENYA, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects with GILENYA were headache, abnormal liver tests, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in arms or legs.

In the pediatric study:

  • The safety in children 10 years and older receiving GILENYA was similar to that seen in adults.
  • The rate of seizures was higher in GILENYA-treated patients compared to that of a leading injectable.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 
Novartis

Speak up and share your message. Tell multiple sclerosis (MS) how you really feel by posting your message on our "HEY MS" message board.

Make sure your voice is heard. We love that you want to say "Take This!" to relapsing MS, but there are still some words even we can't use—words that might not be appropriate. They're defined in the Community Guidelines below. But have no fear; we'll give you a heads up if you use any problematic words by highlighting them after you hit submit. So, go for it, and tell relapsing MS how you really feel!

  • Do not include medical advice or any non-approved use of GILENYA

  • No profane, indecent, or inappropriate language in your message or image, please (a no-no)

  • Avoid using your full name and/or e-mail address in your message, so this personal information remains private and protected

  • Do not include spam, such as links to or URLs for other websites or social networks in your message

  • Refrain from sharing any treatment and/or dosage information, as well as names of specific medicines (brand name or generic) and product manufacturers

  • We take drug product safety seriously. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
    1-800-FDA-1088

Please note that in order to comply with our Community Guidelines as well as the FDA's Prescription Drug Advertising Guidelines, your statement may be subject to modification, while maintaining the spirit of your message. Your photo and statement may be used in other GILENYA marketing materials

 
 

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