Gilenya (fingolimod) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat the following relapsing forms of multiple sclerosis (MS):
- relapsing-remitting MS
- secondary progressive MS that’s active (causing constant or new symptoms)
With MS, your immune system attacks a protective layer that surrounds your nerves. This causes inflammation (swelling and damage) and leads to various symptoms, such as pain and muscle weakness.
Gilenya is also used to treat clinically isolated syndrome (CIS). This is a period of one or more MS-like symptoms, which can be the first sign of MS. In this article we use “MS” to refer to CIS as well as the types of MS that Gilenya is approved to treat.
Gilenya can be used in adults and children ages 10 years and older.
Here are the basics about Gilenya:
- Active ingredient: fingolimod
- Drug class: sphingosine 1-phosphate receptor modulator, which is a type of disease-modifying therapy
- Drug form: oral capsule
- Available as generic: no
Read on for more information about Gilenya and its use in treating MS. You can also refer to this in-depth article for other details about the drug.
Gilenya is approved to treat relapsing forms of multiple sclerosis (MS). It’s also used to treat clinically isolated syndrome (a period of one or more MS-like symptoms, which can be the first sign of MS).
The way Gilenya works
Gilenya works by binding (attaching) to sphingosine 1-phosphate (S1P) receptors* on lymphocytes. Lymphocytes are cells that become active in your lymph nodes (glands throughout your body that are part of your immune system).
Normally, lymphocytes work to protect your body against infections, such as from bacteria or viruses. But with MS, lymphocytes attack the myelin sheath (a protective layer that surrounds nerve cells). This causes inflammation (swelling and damage), which leads to many MS symptoms.
When Gilenya attaches to S1P receptors, it prevents lymphocytes from leaving your lymph nodes. This means that the lymphocytes can’t attack the myelin sheath. This can help reduce the severity of MS symptoms and slow down the progression (worsening) of the disease.
* Receptors are proteins on cells that can bind to other substances and receive chemical messages.
Gilenya and children
Gilenya can be used in children ages 10 years and older. It isn’t known if the drug is safe and effective in children under 10 years old.
Gilenya may cause side effects that are mild or serious. The lists below include some of the main side effects that have been reported with Gilenya use. For information about other potential side effects of the drug, talk with your doctor or pharmacist. You can also see our full article on Gilenya or refer to Gilenya’s medication guide.
Note: After the Food and Drug Administration (FDA) approves a medication, it tracks side effects of the drug. If you develop a side effect while taking Gilenya and would like to inform the FDA, visit MedWatch.
Mild side effects
Gilenya commonly causes mild side effects. These may be temporary, lasting a few days or weeks. But if the side effects last longer, or if they bother you or become severe, it’s important to talk with your doctor or pharmacist.
Mild side effects that are more common with Gilenya include:
- infections, such as sinus infections or the flu
- back pain
- abdominal (belly) pain
- arm or leg pain
- increased liver enzymes
Serious side effects
Gilenya can cause serious side effects in some people. Call your doctor right away if you develop serious side effects while taking Gilenya. If the side effects seem life threatening or you think you’re having a medical emergency, call 911 or your local emergency number immediately.
Less common but serious side effects of Gilenya can include:
- serious heart rhythm problems, such as:
- bradycardia (slow heart rate)
- atrioventricular block (blocked electrical activity in the heart)
- serious infections, such as:
- varicella zoster (also called shingles)
- macular edema (swelling in your retina, which is the back part of your eye)
- progressive multifocal leukoencephalopathy (a viral infection that affects your brain)
- posterior reversible encephalopathy syndrome (a serious condition involving swelling in your brain)
- hypertension (high blood pressure)
- liver damage
- certain types of skin cancer, such as:
- trouble breathing
- tumefactive MS (a rare form of MS that involves a mass in the brain)*
- allergic reaction*
* This wasn’t reported in clinical trials of Gilenya, but it has been reported in people who took the drug since it became available.
† An allergic reaction is possible after taking Gilenya. However, it’s not clear whether this side effect occurred in clinical studies.
Get answers to some frequently asked questions about Gilenya for multiple sclerosis (MS) treatment.
Can Gilenya be used to treat secondary progressive MS?
Yes. Gilenya is approved to treat secondary progressive multiple sclerosis (SPMS) that’s active (causing constant or new symptoms). It’s also approved to treat relapsing-remitting MS and clinically isolated syndrome.
Gilenya is typically taken long term. If you’ve been taking Gilenya for relapsing-remitting MS, you’ll likely continue to take it for SPMS. But it’s up to you and your doctor to determine whether Gilenya treatment is safe and effective for you.
Can I take Gilenya at home?
Yes, but you must take the first dose of Gilenya in the presence of a healthcare professional. This is because the drug has a risk of serious heart-related side effects, including:
- bradycardia (slow heart rate)
- atrioventricular block (blocked electrical activity in the heart)
As a precaution, you’ll have an electrocardiogram (ECG) to check the electrical activity in your heart before your first dose of Gilenya. And your pulse and blood pressure will be checked hourly for at least 6 hours after your first dose. Some people may require 6-hour monitoring again after their second dose of Gilenya. And sometimes, monitoring in a hospital might be necessary.
Talk with your doctor about the possibility of taking Gilenya at home. Novartis Pharmaceuticals, the manufacturer of Gilenya, has a program called Gilenya@Home. With this program, healthcare professionals can come to you.
Gilenya@Home may not be available in all locations. Check the program’s website or call 800-445-3692 for information.
Is Gilenya a cure for MS?
No, Gilenya isn’t a cure for MS. But it may help slow down the disease’s progression (the rate at which it gets worse).
Your doctor can provide more information about how Gilenya treats MS.
Below is information about how Gilenya is used to treat multiple sclerosis (MS) in adults and in children ages 10 years and older.
For adults and children who weigh more than 40 kilograms (88 pounds [lb]), the recommended dosage of Gilenya is 0.5 mg once daily. (1 kilogram is equal to about 2.2 lb.)
For children who weigh 40 kg (88 lb) or less, the recommended dosage of Gilenya is 0.25 mg once daily.
Be sure to take the dosage that your doctor prescribes for you. If you have questions about your dosage, talk with your doctor or pharmacist.
How to use
Gilenya comes as a capsule that you swallow. You may take Gilenya with or without food.
How often to use
You’ll take Gilenya once per day. You can take your dose at any time of day.
Gilenya was an effective disease-modifying treatment for multiple sclerosis (MS) in clinical studies. This means that the drug can help slow down the progression (worsening) of the disease.
Gilenya treatment can help adults and children ages 10 years and older with relapsing-remitting MS spend more time in remission. Remission refers to periods when you have no symptoms or your symptoms are mild.
For details about how Gilenya performed in clinical studies, you can see the manufacturer’s website.
Multiple sclerosis (MS) is a disease that affects the central nervous system (your brain and spinal cord).
It’s not known exactly what causes MS, but it’s thought to be an autoimmune condition. With this type of condition, your immune system attacks healthy tissue.
With MS specifically, your immune system attacks your myelin sheath, which is a protective layer that surrounds your nerves. This causes inflammation (swelling and damage), which leads to many MS symptoms.
Symptoms of MS
MS symptoms may range from mild to severe. Some examples include:
- fatigue (lack of energy)
- muscle pain or weakness
- feelings of numbness, tingling, or “pins and needles”
- vision problems, such as double vision or blurred vision
Gilenya is used to treat relapsing forms of MS, which involve periods of relapse, also called exacerbations. These are periods when symptoms suddenly get worse or new symptoms develop. Relapses are typically followed by remissions, which are periods when you have mild or no symptoms.
Gilenya can be used to treat:
- Relapsing-remitting MS (RRMS). This is the most common type of MS. With RRMS, you have periods of relapse followed by periods of remission.
- Active secondary progressive MS (SPMS). With active SPMS, you may not have periods of remission. Symptoms tend to get worse over time without getting better.
Clinically isolated syndrome
Gilenya is also used to treat a condition called clinically isolated syndrome (CIS). This is a period of MS-like symptoms that lasts for at least 24 hours. This can be the first sign of MS. You may have one or more of the above MS symptoms, or similar symptoms, such as trouble moving or other eye problems.
Who Gilenya is prescribed for
Gilenya is used in adults and in children ages 10 years and older who have CIS, RRMS, or SPMS.
Before you take Gilenya, there’s some important information to keep in mind. The drug may not be a safe option for you if you have certain medical conditions or other factors that affect your health. Some of these are mentioned below.
If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before taking Gilenya:
- if you have a history of heart problems such as a heart attack, heart failure, stroke, or arrhythmia (irregular heart rate or rhythm)
- if you have a history of liver problems, diabetes, or uveitis (a form of eye inflammation)
- if you currently have a serious infection
- if you’ve received a live vaccine* (such as the measles, mumps, and rubella vaccine) within the last 2 months
- if you’re pregnant or planning to become pregnant
- if you’re breastfeeding or planning to breastfeed
- if you’ve had an allergic reaction to Gilenya or any of its ingredients
Note: Tumefactive MS can occur during or after Gilenya treatment. This is a rare type of MS that involves one or more masses in the brain. If you have a relapse (flare-up) of your MS symptoms during or after Gilenya treatment, talk with your doctor. They may do imaging tests to check for signs of tumefactive MS. This condition is more likely to occur if you’ve recently started or stopped Gilenya treatment, or if your relapse is severe. See “Side effect details” in this article for more information about tumefactive MS.
* Live vaccines contain a small amount of weakened live virus or bacteria. (Unlike inactive vaccines, which don’t contain any live virus or bacteria.)
How much Gilenya costs is based on several factors. These can include your treatment plan, the insurance plan you have, the pharmacy you use, and your location.
Gilenya is a brand-name medication. It’s not currently available as a generic. Brand-name drugs usually cost more than generics. To learn about generics drugs, talk with your doctor or pharmacist.
Now that you’ve learned about Gilenya for multiple sclerosis (MS), you may still have some questions. If you do, talk with your doctor or pharmacist for more information about Gilenya treatment.
Here are some other helpful references:
- More details. For details about other aspects of Gilenya, refer to this article.
- Side effects. To learn more about side effects of Gilenya, see this article. You can also refer to the drug’s prescribing information.
- Dosage. For details about Gilenya’s dosage, see this article.
- Information about MS. For more information about MS, see the Medical News Today MS hub and this list of articles.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.