Gilenya (fingolimod)

What is Gilenya?

Gilenya is a brand-name prescription medication. It’s used to treat relapsing forms of multiple sclerosis (MS) in adults and children ages 10 years and older.

MS is an illness in which your immune system (the body’s defense against disease) attacks your central nervous system. With relapsing forms of MS, you have times when symptoms flare up followed by times when you have mild or no symptoms. Relapsing MS may also be called relapsing-remitting MS.

Gilenya is also used to treat clinically isolated syndrome (CIS). This is a period of one or more MS-like symptoms. It can be the first sign of MS. In this article, we use “MS” to refer to CIS and the types of MS that Gilenya treats. See the “Gilenya for multiple sclerosis” section below for details.

Gilenya contains the drug fingolimod. It belongs to a group of drugs called disease-modifying therapies.

Gilenya comes as a capsule that you swallow. You take it once a day.

Effectiveness

Gilenya has been found effective at reducing the number of relapses people with MS have.

In a two-year clinical study, 70% of adults who took Gilenya had no relapses. This was compared to 46% of adults with MS who took a placebo (a treatment with no active drug).

In a one-year clinical study, 83% of adults who took Gilenya had no relapses. This was compared to 70% of adults who took a different MS drug called interferon beta-1a (Avonex, Rebif).

In a clinical study of children (ages 10 to 18 years) with MS, those who took Gilenya had 81.9% fewer relapses each year. This was compared to children with MS who took interferon beta-1a.

Gilenya generic

Gilenya is available only as a brand-name medication. It’s not currently available in generic form.

Gilenya contains the active drug fingolimod.

Gilenya side effects

Gilenya can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Gilenya. These lists do not include all possible side effects.

For more information on the possible side effects of Gilenya, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Gilenya can include:

• headache
• cough
• diarrhea
• nausea
• back pain
• upper respiratory infections, such as sinus infections and bronchitis
• abdominal pain
• pain in your arms and legs
• flu
• high levels of liver enzymes (special proteins made in the liver)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Gilenya aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

• Bradycardia (slow heart rate) or atrioventricular block (blocked electrical signals in the heart). Symptoms can include:
  • dizziness
  • fatigue (lack of energy)
  • chest pain
  • low blood pressure
  • heart palpitations (feeling like your heart skipped a beat)
• Increased risk of infections caused by low levels of lymphocytes, a certain type of white blood cell. Examples of serious infections that can occur include:
  • herpes viral infection
  • meningitis
  • varicella zoster (shingles)
  • pneumonia
• Progressive multifocal leukoencephalopathy (PML), an infection in your brain that’s caused by a virus. For symptoms, see the “Side effect details” section below.
• Macular edema (swelling in your retina, which is in the back part of your eye). Symptoms can include:
  • blurry vision
  • changes in how you see colors
  • trouble seeing details clearly
• Posterior reversible encephalopathy syndrome (PRES), a brain disorder that’s often caused by pressure in the brain. Symptoms can include:
  • severe headache
  • confusion
  • loss of vision
  • blurry vision
  • seizures
• Trouble breathing, including shortness of breath.
• Liver damage. Signs and symptoms can include:
  • high levels of liver enzymes (special proteins made in the liver)
  • nausea
  • vomiting
  • abdominal pain
  • fatigue (lack of energy)
  • loss of appetite
  • dark-colored urine
  • jaundice (yellowing of your skin and the whites of your eyes)
• Increased blood pressure. Symptoms can include:
  • headaches
  • dizziness
  • chest pain
  • shortness of breath
• Increased risk of skin cancer, including basal cell carcinoma and melanoma. Symptoms can include:
  • changes in your skin
  • new patches or lesions on your skin
• Tumefactive MS (a rare form of MS that involves a mass in the brain). For symptoms, see the “Tumefactive MS” section under “Side effect details” below.
• Severe allergic reactions. For symptoms, see the “Allergic reaction” section below.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Gilenya. It’s not known how many people have had an allergic reaction after taking Gilenya. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Gilenya. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Eye side effects

Eye problems can be a side effect of Gilenya treatment. In clinical studies of people with multiple sclerosis (MS), 4% of people who took Gilenya reported blurry vision as a side effect. This was compared to 2% of people who took a placebo (a treatment with no active drug).

Eye problems may also be a symptom of rare but serious side effects related to Gilenya use. For example, changes in your vision may be a symptom of progressive multifocal leukoencephalopathy (PML). This is a type of brain infection that can make it hard to see completely out of each eye. If you notice this symptom, tell your doctor right away.

If Gilenya is causing your vision problems, your doctor may recommend that you stop taking the drug for a time.

Macular edema

Vision problems can also be caused by macular edema, another rare but serious side effect of Gilenya. Macular edema is a condition in which fluid builds up in the macula. This is part of your retina, which is in the back part of your eye. The fluid buildup can cause you to have blurry vision and see fine details less clearly.

In clinical studies of people with MS, macular edema was reported in 0.5% of people who took 0.5 mg of Gilenya. The side effect was also reported in 1.5% of people who took 1.25 mg of Gilenya. Of the people who took a placebo, 0.4% reported developing macular edema.

This side effect was more commonly reported within the first few months of when people started to take Gilenya. However, macular edema can occur at any time during treatment.

If you have diabetes or have had uveitis (swelling in your eye), you may have a higher risk for this side effect.

Because of the risk of macular edema, you’ll have an eye exam before you start taking Gilenya. Your doctor will check your eye health again after you’ve been taking the drug for a few months. If you have diabetes or a history of uveitis, your doctor will continue to monitor your eye health while you take Gilenya.

If you develop macular edema during your treatment, your doctor may want you to you stop taking the drug for a time. For most people who stopped taking Gilenya due to macular edema, this side effect went away.

Talk with your doctor about your eye health and discuss your risk for vision problems. Your doctor can also tell you when to contact them if you notice any changes in your sight.

PML

Progressive multifocal leukoencephalopathy (PML) is a rare but serious side effect that can occur with Gilenya use. PML is a brain infection that’s caused by a virus. PML typically occurs only in people who have a weakened immune system, such as when they’re taking Gilenya. (Your immune system is your body’s defense against disease.)

Symptoms of PML include:

• weakness on one side of your body
• being more clumsy than usual
• vision changes
• confusion
• personality changes
• memory problems

The symptoms of PML usually get worse over days to weeks. PML can be very serious and lead to severe disability or death, if not treated. Examples of severe disability include permanent memory loss and personality changes.

PML didn’t occur in clinical studies of Gilenya. However, PML was reported in people who took the drug once it was available to the public (post-marketing). Therefore, it’s not known exactly how many people have developed PML while taking Gilenya.

If you have symptoms of PML, tell your doctor right away. They’ll likely recommend that you stop taking Gilenya until they know whether the drug is causing your symptoms.

Skin cancer

The risk of certain skin cancers is increased with Gilenya use. These cancers include basal cell carcinoma and melanoma.

Basal cell carcinoma starts in the basal cells, which are part of the lining of your skin. This type of cancer usually looks like sores or red patches on your skin.

Melanoma often develops in moles, which can change in shape, size, or color as the cancer grows.

In clinical studies of people with MS, 2% of people who took Gilenya developed basal cell carcinoma. This was compared to 1% of people who took a placebo.

No cases of melanoma were reported during clinical studies of Gilenya. However, melanoma did occur in people who took the drug once it was available to the public (post-marketing). Therefore, it’s not known exactly how many people have developed melanoma while taking Gilenya.

During your Gilenya treatment, your doctor will monitor your skin for any changes that may be signs of cancer. And there are steps that you can take as well. To help reduce your risk for skin cancer:

• limit your time in the sun
• apply a broad-spectrum sunscreen that has a sun protection factor (SPF) of 30 or higher
• wear protective clothing, such as long sleeves and a hat, to help block the sun

Other cases of cancer, including lymphomas, have also been reported with Gilenya use. It’s not known whether Gilenya causes these cancers, though. Talk with your doctor about your risk for cancer during Gilenya treatment.

Hair loss

Hair loss was a side effect reported with Gilenya use. In clinical studies of people with MS, 3% of people who took Gilenya had hair loss during treatment. This was compared to 2% of people who took a placebo.

If you’re concerned about hair loss with Gilenya use, talk with your doctor.

High blood pressure

Increases in blood pressure and hypertension (high blood pressure) were reported with Gilenya use. In clinical studies of people with MS, 8% of people who took Gilenya had hypertension during treatment. This was compared to 4% of people who took a placebo.

On average, people who took Gilenya had a higher increase in blood pressure than people who took a placebo. The average increases in blood pressure for people who took Gilenya were:

• 3 mmHg more than people who took a placebo. This was for systolic blood pressure, which is the top number of your blood pressure measurement.
• 2 mmHg more than people who took a placebo. This was for diastolic blood pressure, which is the bottom number of your blood pressure measurement.

The generally recommended blood pressure goal is less than 120/80 mmHg. Your doctor will monitor your blood pressure regularly to make sure your numbers are within a healthy range. If your blood pressure is too high, your doctor will work with you to help lower it.

Liver damage

Liver damage has been reported with Gilenya use. In clinical studies, 14% of people who took Gilenya for MS had increases in the levels of liver enzymes. These are special proteins made in the liver. High levels of liver enzymes are a sign of liver injury or liver damage. In comparison, 3% of people who took a placebo had increases in the levels of liver enzymes.

More severe increases in liver enzymes occurred in 4.5% of people who took Gilenya. This was compared to 1% of people who took a placebo.

When you have liver damage, you’ll likely also have other symptoms, including:

• nausea
• vomiting
• belly pain
• fatigue (lack of energy)
• loss of appetite
• jaundice (yellowing of your skin and the white part of your eyes)
• dark-colored urine

If you have severe liver damage while taking Gilenya, your doctor will likely recommend that you stop treatment. For most people, their liver enzyme levels returned to normal within two months after they stopped taking Gilenya.

Lymphopenia

Lymphopenia (low levels of certain white blood cells called lymphocytes) has been reported with Gilenya use. In clinical studies, 7% of people who took Gilenya for MS had lymphopenia. This was compared to less than 1% of people who took a placebo.

Lymphopenia can increase your risk for infections. This is because lymphocytes normally work to fight foreign invaders, such as bacteria or viruses, in your body. When lymphocyte levels are low, your immune system isn’t able to protect you as well from these infections.

Before you start taking Gilenya, your doctor will check your lymphocyte levels. They’ll also make sure that any infections you had in the past or that you currently have are treated before you start taking Gilenya. This is because past infections may still be in your body, but they’re inactive, so you don’t have symptoms. Taking Gilenya may cause the infections to become active, so symptoms could appear again.

If you notice symptoms of an infection during Gilenya treatment, tell your doctor right away. General symptoms of an infection can include fatigue (lack of energy), muscle aches, and fever.

Back pain

Back pain was one of the more common side effects reported with Gilenya use. In clinical studies, 10% of people who took Gilenya for MS had back pain. This was compared to 9% of people who took a placebo.

Back pain is also a common symptom of MS. This may be due to nerve damage or spasticity (stiff muscles) in your back.

If you have back pain during Gilenya treatment, talk with your doctor. They can recommend safe pain relievers. Your doctor can also advise you on exercises and physical therapy to help reduce your back pain.

Tumefactive MS

It’s possible to experience tumefactive MS during or after Gilenya treatment. Tumefactive MS is a rare type of MS that involves one or more masses in the brain. Symptoms may include:

• changes in thinking
• confusion
• headaches
• trouble talking and understanding speech
• seizures

This condition wasn’t reported in clinical trials of Gilenya. However, tumefactive MS has been reported in people who took the drug once it became available to the public.

Tumefactive MS can occur at any time. Most cases occurred within 9 months of starting Gilenya treatment. This condition also developed up to 4 months after stopping Gilenya treatment, in some people.

If you experience a relapse (flare-up) of your MS symptoms, be sure to talk with your doctor. They might do imaging tests to check for signs of tumefactive MS. This is more likely if you’ve recently started or stopped Gilenya treatment, or if your relapse is severe. They may recommend treatment for tumefactive MS if they confirm that you have it.

Insomnia (not a side effect)

Insomnia wasn’t a side effect seen in clinical studies of Gilenya. However, other sleep disorders may be an issue if you’re living with MS. These disorders can include:

• sleep apnea, which is pausing in breathing while you sleep
• nocturia, which is waking up often at night to urinate
• other problems that prevent you from getting a good night’s rest

If you are having trouble falling or staying asleep, talk with your doctor. They’ll work with you to find the cause of your sleep problems. They can also suggest treatments to help you sleep better.

Side effects in children

Common and serious side effects of Gilenya in children were similar to those seen in adults.

However, in a clinical study, 5.6% of children who took Gilenya for MS had seizures. This was compared to 0.9% of children who took interferon beta-1a (a different MS treatment). In other clinical studies, 0.9% of adults who took Gilenya had seizures. This was compared to 0.3% of adults who took a placebo (a treatment with no active drug).

However, the studies in adults were done separately from the study in children, so the studies can’t be compared directly. Therefore, it’s not known whether Gilenya causes more seizures in children than in adults or if MS itself caused the seizures.

If your child has a seizure during Gilenya treatment, tell your child’s doctor right away. And be sure to mention any other side effect that concerns you. Also, ask the doctor what to do in case your child does have a seizure.

Gilenya cost

As with all medications, the cost of Gilenya can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Gilenya, or if you need help understanding your insurance coverage, help is available.

Novartis Pharmaceuticals Corporation, the manufacturer of Gilenya, offers a copay program to help lower the cost of your prescription. Novartis’ Go Program may also assist you in finding other programs to help you pay for your medication. For more information and to find out if you’re eligible for support, call 800-445-3692 or visit the program’s website.

Common questions about Gilenya

Here are answers to some frequently asked questions about Gilenya.

Is Gilenya an immunosuppressant?

Yes, Gilenya is an immunosuppressant. This means that the drug works to reduce certain functions of your body’s immune system, which can reduce your ability to fight germs and diseases. Gilenya works this way in order to reduce multiple sclerosis (MS) symptoms. See the “How Gilenya works” section below for more information.

Will Gilenya make me lose weight or gain weight?

It might. Weight gain and weight loss weren’t reported as side effects in clinical studies of Gilenya. However, each person’s body may respond differently to Gilenya.

Weight loss could be a symptom of liver damage, which is a rare but serious side effect of Gilenya. If you have liver damage due to Gilenya treatment, you may lose your appetite. And this loss of appetite could lead you to lose weight. So if you have liver damage, you may need to stop taking Gilenya for a time.

If you notice unexplained weight loss or weight gain while taking Gilenya, talk with your doctor. They’ll help find the cause of your weight changes. Your doctor can then recommend helpful ways for you to stay at a healthy weight.

Will I need tests before and during Gilenya treatment?

Yes. Before you start taking Gilenya, your doctor will give you the following tests:

• heart checkup, if you have a history of heart problems
• blood test, to check your levels of white blood cells and liver enzymes (proteins)
• varicella zoster virus test, if you don’t have proof that you’ve had chickenpox or if you haven’t received the varicella zoster virus (chickenpox) vaccine
• eye test

You’ll need another eye test after taking Gilenya for three to four months. (Your doctor will check for swelling in the back part of your eye.) And you may need more follow-up eye exams if you have diabetes or a history of uveitis (swelling in the eye).

Can I take Gilenya at home?

You might be able to take Gilenya at home. Novartis Pharmaceuticals, the manufacturer of Gilenya, has a program called Gilenya@Home. In this program, healthcare professionals can come to your house.

The healthcare professionals may even be able to perform some of the tests you need before you start taking Gilenya. (See the above question to learn more about these tests.) They can also give you your first dose of the drug and monitor you for side effects. If you have serious side effects, the healthcare professionals can treat them.

Gilenya@Home may not be available in all locations. See the program’s website or call 800-445-3692 for more information.

What vaccines should I avoid while I’m taking Gilenya?

You shouldn’t get live vaccines while you’re taking Gilenya because it could lead to a serious infection.

Live vaccines contain weakened forms of bacteria or viruses, but they don’t cause infections if you have a healthy immune system. (Your immune system is your body’s defense against disease.) However, live vaccines could cause infections if you’re taking Gilenya. This is because the drug may weaken your immune system.

If you get a live vaccine, you may end up with the infection that the vaccine is meant to prevent.

You also shouldn’t get live vaccines for at least two months after your last dose of Gilenya. This is because Gilenya stays in your system for about two months after you stop taking it. During this time, you may still be at risk of getting an infection from the live vaccine.

Examples of live vaccines that you shouldn’t get while taking Gilenya treatment or for two months after treatment include:

• measles, mumps, rubella (MMR)
• rotavirus
• chickenpox
• smallpox
• yellow fever

You should also try to avoid getting inactive (not live) vaccines during Gilenya treatment. This is because your immune system might not create enough of a response to properly vaccinate you. So you might still be at risk for that disease in the future. But you can’t get the disease from the inactive vaccine itself because the vaccine doesn’t contain any live bacteria or viruses.

Before you start taking Gilenya, ask your doctor whether you’re up to date on all the vaccines you need.

Will I have withdrawal symptoms if I stop taking Gilenya?

No, Gilenya doesn’t cause withdrawal (symptoms that occur if you stop taking a drug that your body is dependent on). But it’s possible that your condition will get worse when you stop taking Gilenya.

There have been reports of people having a severe worsening of MS symptoms when they stopped taking Gilenya. These symptoms included worsened trouble with balance, walking, vision, and bladder or bowel control. This worsening of symptoms occurred within about three to six months of stopping treatment. For most people, their condition didn’t return to how it was before they stopped taking Gilenya.

When you stop taking Gilenya, your doctor will monitor you closely for worsening symptoms. If your symptoms do get worse, they’ll recommend treatments that can help.

Can I spend time in the sun while I’m taking Gilenya?

Yes. You can spend time in the sun during your Gilenya treatment. However, the drug can increase your risk for certain types of skin cancers. Therefore, it’s important that you limit how much time you spend in the sun. You should also use sunscreen with a high sun protective factor (SPF) and wear clothing that covers a lot of your skin. This can help reduce your risk for skin cancer.

Gilenya for multiple sclerosis

The Food and Drug Administration (FDA) approves prescription drugs such as Gilenya to treat certain conditions.

Gilenya is FDA-approved to treat relapsing forms of multiple sclerosis (MS). Relapsing MS involves relapses, or “attacks,” of symptoms. During a relapse, symptoms such as fatigue (lack of energy), muscle weakness, and pain get worse.

Relapses are followed by remissions, which are periods of time when you have mild symptoms or are without symptoms. During remission, MS doesn’t seem to get worse.

Relapsing MS is the most common type of the disease. You can see our MS hub for more information about this condition.

Gilenya is also used to treat clinically isolated syndrome (CIS). This is a period of one or more MS-like symptoms. It can be the first sign of MS. In this article, we use “MS” to refer to CIS and the types of MS that Gilenya treats.

Gilenya has been found effective for treating people with relapsing forms of MS. In a two-year clinical study, 70% of adults who took Gilenya had no relapses. This was compared to 46% of people who took a placebo (a treatment with no active drug). During this study, people who took Gilenya had a 30% lower risk for their MS getting worse. This was compared to people who received a placebo.

In a one-year clinical study, 83% of adults who took Gilenya had no relapses. This was compared to 70% of people who took a different MS drug called interferon beta-1a (Avonex, Rebif). However, the risk for the disease getting worse wasn’t different between the two groups.

Gilenya for children

Gilenya is FDA-approved to treat children ages 10 years and older with relapsing forms of MS.

In a clinical study with children with MS, those who took Gilenya had 81.9% fewer relapses each year. This was compared to children who took interferon beta-1a (Avonex, Rebif), which is another type of medication used to treat MS.

Gilenya dosage

The Gilenya dosage your doctor prescribes will depend on your age and your weight.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Gilenya comes as a capsule that you swallow.

The drug is available in two strengths: 0.25-mg capsules and 0.50-mg capsules.

Dosage for multiple sclerosis

For adults who weigh more than 40 kilograms (kg) or about 88 pounds (lb),* the usual dosage of Gilenya is 0.5 mg once a day. You can take the drug with or without food.

If you weigh 40 kg (about 88 lb) or less, ask your doctor what dosage is right for you.

* One kg is equal to about 2.2 lb.

Pediatric dosage

The usual dosage of Gilenya for children is based on their weight.

For children ages 10 years and older who weigh more than 40 kg (about 88 lb), the usual dosage is 0.5 mg once a day.

For children ages 10 years and older who weigh 40 kg (about 88 lb) or less, the usual dosage is 0.25 mg once a day.

Children can take Gilenya with or without food.

What if I miss a dose?

If you miss a dose of Gilenya, call your doctor right away. Don’t try to make up for the missed dose by taking another capsule. This can cause serious side effects. Your doctor may need to monitor you when you take the next dose. This is because Gilenya can cause very serious heart problems if you take it after a period of not having the drug in your system.

To help make sure that you don’t miss a dose, try setting a reminder in your phone. A pill timer may also be useful.

Will I need to use this drug long term?

Gilenya is meant to be used as a long-term treatment. If you and your doctor determine that Gilenya is safe and effective for you, you’ll likely take it long term.

Alternatives to Gilenya

Other drugs are available that can treat multiple sclerosis (MS). Some may be better suited for you than others. If you’re interested in finding an alternative to Gilenya, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Other drugs that can be taken to treat MS include:

• alemtuzumab (Lemtrada)
• azathioprine (Azasan, Imuran)
• cladribine (Mavenclad)
• dimethyl fumarate (Tecfidera)
• glatiramer (Copaxone, Glatopa)
• interferon beta-1a (Avonex, Rebif)
• mitoxantrone
• natalizumab (Tysabri)
• ocrelizumab (Ocrevus)
• teriflunomide (Aubagio)

Gilenya vs. Tecfidera

You may wonder how Gilenya compares to other medications that are prescribed for similar uses. Here we look at how Gilenya and Tecfidera are alike and different.

Gilenya contains the active drug fingolimod. Tecfidera contains the active drug dimethyl fumarate.

Uses

Gilenya and Tecfidera are both approved by the Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS).

Gilenya is also approved to treat children with relapsing forms of MS who are ages 10 years and older.

Drug forms and administration

Gilenya and Tecfidera both come as capsules that you swallow.

Gilenya is available in two strengths: 0.25-mg capsules and 0.5-mg capsules. You take the drug once a day.

Tecfidera is also available in two strengths: 120-mg capsules and 240-mg capsules. You take the drug twice a day.

Side effects and risks

Gilenya and Tecfidera both contain different drugs. Therefore, both medications can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Gilenya, with Tecfidera, or with both drugs (when taken individually).

• Can occur with Gilenya:
  • headache
  • cough
  • back pain
  • upper respiratory infections, such as sinus infections and bronchitis
  • pain in your arms and legs
  • flu
  • high levels of liver enzymes (special proteins made in the liver)
• Can occur with Tecfidera:
  • flushing or redness of skin
  • itchy skinrash
  • indigestion (upset stomach)
• Can occur with both Gilenya and Tecfidera:
  • belly pain
  • diarrhea
  • nausea

Serious side effects

These lists contain examples of serious side effects that can occur with Gilenya, with Tecfidera, or with both drugs (when taken individually).

• Can occur with Gilenya:
  • bradycardia (slow heart rate) or atrioventricular block (blocked electrical signals in the heart)
  • macular edema (swelling in your retina, which is in the back part of your eye)
  • posterior reversible encephalopathy syndrome (PRES), a brain disorder that’s often caused by pressure in the brain
  • trouble breathing, including shortness of breath
  • increased blood pressure
  • increased risk of skin cancer, including basal cell carcinoma and melanoma
• Can occur with Tecfidera:
  • severe flushing that may require treatment
• Can occur with both Gilenya and Tecfidera:
  • severe allergic reaction
  • progressive multifocal leukoencephalopathy (PML), an infection in your brain that’s caused by a virus
  • increased risk of infections caused by low levels of lymphocytes, a certain type of white blood cell
  • liver damage

Effectiveness

Gilenya and Tecfidera are both used to treat adults with relapsing forms of MS.

The use of Gilenya and Tecfidera in treating MS has been directly compared in clinical studies.

In a 2.5-year clinical study, people who took Gilenya had a 22% lower risk of having a relapse (a flare-up of symptoms). This was compared to people who took Tecfidera. In addition, people who took Gilenya were 51% less likely to stop taking the drug than people who took Tecfidera. Reasons for people stopping either treatment were negative side effects or because the drug wasn’t effective for them.

Another clinical study also found that people who took Gilenya were less likely to stop their treatment than people who took Tecfidera. People who took Tecfidera had a 55% greater risk of stopping treatment than those who took Gilenya over a two-year period. However, this study didn’t find a difference between the two drugs in the risk of having a relapse.

A third study also found no difference between Gilenya and Tecfidera in the risk for relapses. However, in this study, people who took Tecfidera were more likely to relapse sooner than people who took Gilenya.

Costs

Gilenya and Tecfidera are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Gilenya may cost more than Tecfidera. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Gilenya vs. Aubagio

In addition to Tecfidera (above), Aubagio is another drug that has some uses similar to those of Gilenya. Here we look at how Gilenya and Aubagio are alike and different.

Gilenya contains the active drug fingolimod. Aubagio contains the active drug teriflunomide.

Uses

Gilenya and Aubagio are both approved by the Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS).

Gilenya is also approved to treat children with relapsing forms of MS who are ages 10 years and older.

Drug forms and administration

Gilenya comes as a capsule, and Aubagio comes as a tablet. Both drugs are taken by swallowing them.

Gilenya is available as a 0.25-mg capsule and a 0.5-mg capsule. You take the drug once a day.

Aubagio is available as a 7-mg tablet and a 14-mg tablet. You take the drug once a day.

Side effects and risks

Gilenya and Aubagio contain different drugs. Therefore, they can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Gilenya, with Tecfidera, or with both drugs (when taken individually).

• Can occur with Gilenya:
  • cough
  • back pain
  • upper respiratory infections, such as sinus infections and bronchitis
  • belly pain
  • pain in your arms and legs
  • flu
• Can occur with Aubagio:
  • hair loss
  • joint pain
  • paresthesia (numbness, itchiness, or pins and needles feeling in your arms or legs)
• Can occur with both Gilenya and Aubagio:
  • headache
  • diarrhea
  • nausea
  • high levels of liver enzymes (special proteins made in the liver)

Serious side effects

These lists contain examples of serious side effects that can occur with Gilenya, with Aubagio, or with both drugs (when taken individually).

• Can occur with Gilenya:
  • bradycardia (slow heart rate) or atrioventricular block (blocked electrical signals in the heart)
  • progressive multifocal leukoencephalopathy (PML), an infection in your brain that’s caused by a virus
  • macular edema (swelling in your retina, which is in the back part of your eye)
  • posterior reversible encephalopathy syndrome (PRES), a brain disorder that’s often caused by pressure in the brain
  • trouble breathing, including shortness of breath
  • increased risk of skin cancer, including basal cell carcinoma and melanoma
• Can occur with Aubagio:
  • low levels of neutrophils and platelets, which are types of blood cells
  • peripheral neuropathy, which is damage to the nerves in your arms and legs
  • new or worsening interstitial lung disease, which is swelling and scarring in your lungs
• Can occur with both Gilenya and Aubagio:
  • liver damage
  • increased risk of infections caused by low levels of lymphocytes, a certain type of white blood cell
  • severe allergic reactions
  • increased blood pressure

Effectiveness

Gilenya and Aubagio are both used to treat relapsing forms of MS in adults.

The use of Gilenya and Aubagio in treating MS has been directly compared in a clinical study.

In a 2.5-year clinical study, people who took Gilenya had a 23% lower risk of having a relapse (flare-up of symptoms) than people who took Aubagio. Also, people who took Gilenya were 44% less likely to stop taking the drug than people who took Aubagio. Reasons for people stopping either treatment were negative side effects or because the drug wasn’t effective for them.

Costs

Gilenya and Aubagio are both brand-name drugs. There are currently no generic forms of Gilenya. However, there is a generic form of Aubagio called teriflunomide. Brand-name medications usually cost more than generics.

Gilenya may cost more than Aubagio. And teriflunomide may cost less than either Gilenya or Aubagio. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

How to take Gilenya

You should take Gilenya according to your doctor or another healthcare professional’s instructions. You take Gilenya by swallowing a capsule.

Gilenya first dose observation

The first dose of Gilenya can cause a decrease in your heart rate.* If you heart rate is too slow, it can cause serious problems, such as an abnormal heart rate or rhythm. This is a heartbeat that’s too fast, too slow, or uneven, which can lead to a heart attack or stroke.

Because of this possible side effect, you’ll take your first dose of Gilenya in your doctor’s office or a clinic. (You may also be able to take Gilenya at home. See the “Common questions about Gilenya” section above to learn more.) You’ll stay there for at least six hours after you take your first dose. This allows your healthcare professional to observe, and treat, any serious side effects that could occur after taking the drug.

Before you take your first dose, your doctor will give you an electrocardiogram (ECG or EKG). This is a quick, painless test that measures the electrical activity in your heart. You’ll be given another ECG a few hours after you take Gilenya. The doctor will compare your heart’s activity from before and after you took the drug. The results will show whether your heart rate slowed down to unsafe levels.

It’s possible that you may have a severe decrease in your heart rate after your first dose Gilenya. Or you may have other health issues that can cause your heart rate to slow greatly. In either of these cases, you may need to stay at your doctor’s office or clinic for longer than six hours. It’s possible that you may even have to spend the night. Your doctor will tell you how long you should stay based on your medical conditions.

If you’ve stopped taking Gilenya and will restart your treatment, you may also need to repeat your stay at your doctor’s office or clinic. Ask your doctor if you have any questions.

Children will also need to be monitored when they start taking a higher dosage of Gilenya.

* Your heart rate should return to normal within one month of starting to take Gilenya.

When to take

You’ll take Gilenya once a day. You can take the drug at any time of the day.

If you miss a dose of Gilenya, call your doctor right away.

To help make sure that you don’t miss a dose, set a reminder in your phone. Or get a pill timer.

Taking Gilenya with food

You can take Gilenya with or without food.

Can Gilenya be crushed, split, or chewed?

It’s not known whether you can crush, split, or chew Gilenya. If you have a hard time swallowing Gilenya capsules, talk with your doctor or pharmacist. They can suggest ways to make it easier to swallow pills.

Gilenya and alcohol

There’s no known interaction between Gilenya and alcohol.

However, alcohol and Gilenya can both cause liver damage on their own. It’s possible that heavy drinking while taking Gilenya can increase your risk for liver damage.

On the other hand, small amounts of alcohol, such as one drink, could ease some symptoms of multiple sclerosis (MS). However, there isn’t enough research to know for sure whether alcohol is safe for everyone with MS. Talk with your doctor about whether drinking alcohol is safe for you.

Gilenya interactions

Gilenya can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Gilenya and other medications

Below is a list of medications that can interact with Gilenya. This list doesn’t contain all drugs that may interact with Gilenya.

Before taking Gilenya, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Gilenya and vaccines

You shouldn’t get live vaccines while you’re taking Gilenya or for two months after you stop taking the drug. This is because Gilenya reduces certain activities of your immune system (your body’s defense against disease), and your body can’t fight germs as well. If you get a live vaccine, you may end up with the infection that the vaccine is meant to prevent.

Examples of live vaccines that you shouldn’t get include:

• measles, mumps, and rubella (MMR)
• rotavirus
• chickenpox

For more information on Gilenya and vaccines, see the “Common questions about Gilenya” section above.

Gilenya and certain antidepressants and antipsychotics

Taking Gilenya with certain antidepressants or antipsychotics can cause abnormal heart rhythms and bradycardia (a slow heart rate). These heart rhythm issues can increase your risk for serious heart problems.

Examples of drugs that can cause heart problems if taken with Gilenya include citalopram (Celexa), chlorpromazine, and haloperidol (Haldol).

If you are taking a drug that can cause abnormal heart rhythms or bradycardia, talk with your doctor. They’ll likely monitor you overnight at a clinic for your first dose of Gilenya.

Gilenya and methadone

Taking Gilenya with methadone (Methadose, Dolophine) can increase your risk for bradycardia (slow heart rate) and abnormal heart rhythms. These can increase your risk for serious heart problems.

If you’re taking methadone when you begin Gilenya treatment, talk with your doctor. They’ll likely monitor you overnight at a clinic for your first dose of Gilenya.

Gilenya and erythromycin

Taking Gilenya and erythromycin (Eryped) can cause bradycardia (slow heart rate) and abnormal heart rhythms. These can cause serious heart problems.

If you’re taking erythromycin when you start taking Gilenya, talk with your doctor. They’ll likely monitor you overnight at a clinic for your first dose of Gilenya.

Gilenya and oral ketoconazole

Taking Gilenya with ketoconazole that you take by mouth can increase levels of Gilenya in your body. This can increase your risk for serious side effects from Gilenya. If you’re taking ketoconazole by mouth with Gilenya, your doctor will monitor you closely for side effects.

Gilenya and certain blood pressure or heart rate drugs

Taking Gilenya with certain blood pressure medications or drugs that lower your heart rate can cause bradycardia (slow heart rate) and abnormal heart rhythms. These can increase your risk for serious heart problems.

Examples of blood pressure or heart rate drugs that can increase your risk for heart problems when taken with Gilenya include:

• diltiazem (Cardizem, Cartia XT)
• verapamil (Calan, Verelan)
• digoxin (Lanoxin)
• metoprolol (Lopressor, Toprol XL)
• atenolol (Tenormin)
• propranolol (Inderal, Innopran XL)

If you’re using one of these medications, talk with your doctor. They may want you to stop taking it and use a different drug before you start Gilenya treatment. If you can’t switch to a different medication, your doctor will likely monitor you overnight at a clinic for your first Gilenya dose.

Gilenya and corticosteroids

Both Gilenya and corticosteroids can reduce certain immune system functions (the immune system is your body’s defense against disease). So taking both drugs together can make it even harder for you to fight germs. This can increase your risk of serious infections.

Examples of corticosteroids that can weaken your immune system further if you take them with Gilenya include:

• prednisone (Rayos)
• betamethasone
• dexamethasone
• prednisolone (Medrol)

If you need to take a corticosteroid with Gilenya, your doctor will monitor you closely for signs and symptoms of infections.

Gilenya and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Gilenya. However, you should still check with your doctor or pharmacist before using any of these products while taking Gilenya.

Gilenya and pregnancy

It’s not known whether Gilenya is safe to take during pregnancy. In animal studies, serious fetal harm and fetal death were seen when Gilenya was given during pregnancy. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or thinking about becoming pregnant, talk with your doctor. They’ll discuss with you the risks and benefits of taking Gilenya during pregnancy. If you become pregnant while taking Gilenya, call your doctor right away.

There’s also a pregnancy registry that collects information about Gilenya use during pregnancy. The registry helps doctors and patients learn more about the safety of certain drugs during pregnancy. If you took Gilenya while you were pregnant, you’re encouraged to call the registry at 877-598-7237. You can also email the registry at gpr@quintiles.com or visit the registry website.

Gilenya and birth control

In animal studies, Gilenya was found to cause serious harm to the fetus when given during pregnancy. Because of how serious the harm may be to humans, females* should use effective birth control while taking Gilenya. Examples include condoms, birth control pills, and birth control implant devices (such as intrauterine devices).

Females should also use effective birth control for at least two months after they stop taking Gilenya. This is because Gilenya stays in your system for about two months after you stop taking it. During this time, it’s possible that the drug could still cause harm to a fetus if pregnancy occurs.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Gilenya and breastfeeding

It’s not known whether Gilenya is safe to take while breastfeeding. In animal studies, Gilenya did pass into breast milk. However, animal studies don’t always predict what will happen in humans.

If you’re breastfeeding and are thinking about taking Gilenya, talk with your doctor about the risks and benefits.

How Gilenya works

Multiple sclerosis (MS) is a condition that affects your central nervous system. MS is caused by an overactive immune system (your body’s defense against disease). Your immune system mistakenly attacks the myelin sheath, which is the protective layer around your nerve fibers. That protective layer helps nerves send messages quickly and correctly to the rest of your body.

Damage to your myelin sheaths causes inflammation (swelling) and scarring, called lesions, on your nerves. Lesions prevent your nerves from sending signals correctly throughout your body. This causes the common symptoms of MS, including muscle weakness, trouble balancing and walking, and pain.

With relapsing forms of MS, you have times when your symptoms go away completely or are very mild. This is followed by times when your symptoms relapse (come back). Relapsing forms of MS are the most common forms of the condition.

Gilenya works to help ease MS symptoms for people with relapsing forms of MS. The drug is thought to work by binding (attaching) to certain molecules called sphingosine 1-phosphate (S1P) receptors. The S1P receptors are found on immune system cells that become active in your lymph nodes. (Lymph nodes are small glands throughout your body that help your immune system fight disease.) This is thought to be Gilenya’s mechanism of action (the way the drug works in your body).

Immune system cells in your lymph nodes can help fight germs. But immune system cells can also attack your body’s own cells by mistake, including myelin sheaths.

When Gilenya binds to S1P receptors, the drug helps prevent certain immune system cells, called lymphocytes, from leaving the lymph nodes. Because the lymphocytes can’t exit the lymph nodes, they can’t attack myelin sheaths throughout your body. This helps decrease how severe your MS symptoms are and how often you have symptoms.

How long does it take to work?

It may take several weeks to months before you see your MS symptoms improve.

But in your body, Gilenya starts working within a few hours after you take your first dose.

In a small clinical study, the number of lymphocytes in people’s blood decreased within four to six hours of taking the drug. A lower level of lymphocytes in your blood decreases the number of cells that can attack your nerve fibers.

Gilenya precautions

Before taking Gilenya, talk with your doctor about your health history. Gilenya may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Serious heart problems. You shouldn’t take Gilenya if you’ve had certain types of abnormal electrical activity in your heart. These include heart block or abnormal heart rhythms, such as long QT syndrome. You also shouldn’t take Gilenya if you’ve had any of the following in the past six months:

• heart attack
• stroke
• transient ischemic attack (TIA), which is also called a ministroke
• heart failure that required you to stay in the hospital
• class III or IV heart failure
• unstable angina (chest pain when you’re at rest)

Severe allergic reaction. If you’ve had a severe allergic reaction to Gilenya or any of its ingredients in the past, you shouldn’t take Gilenya. If you’re unsure whether you’ve had a severe allergic reaction to Gilenya, talk with your doctor before starting treatment.

Serious infections. If you have a serious infection, it may need to be treated before you can start taking Gilenya. Examples of serious infections include pneumonia and shingles. Be sure to tell your doctor about all serious or ongoing infections you’ve had before you take Gilenya.

Tumefactive multiple sclerosis (MS). It’s possible to experience tumefactive MS during or after Gilenya treatment. This is a rare type of MS that involves one or more masses in the brain. If you experience a relapse (flare-up) of your MS symptoms, be sure to talk with your doctor. They might do imaging tests to check for signs of tumefactive MS. This is more likely if you’ve recently started or stopped Gilenya treatment, or if your relapse is severe. See the “Gilenya side effects” section above for details about tumefactive MS.

Pregnancy. It’s not known whether Gilenya is safe to take during pregnancy. See “Gilenya and pregnancy” above for more details.

Note: For more information about the potential negative effects of Gilenya, see the “Gilenya side effects” section above.

Gilenya overdose

Using more than the recommended dosage of Gilenya can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

• bradycardia (slow heart rate)
• abnormal electrical activity in the heart, including atrioventricular block
• low blood pressure
• dizziness
• chest pain
• heart palpitations (feeling like your heart skipped a beat)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor right away. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Gilenya expiration, storage, and disposal

When you get Gilenya from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Keep your Gilenya capsules at room temperature in a tightly sealed container. Avoid storing this medication in areas where it could get damp or wet, such as in a bathroom.

Disposal

If you no longer need to take Gilenya and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.