Generic Name: fingolimod, Oral capsule

Generic Name:

fingolimod, Oral capsule

Gilenya

All Brands

  • Gilenya
SECTION 1 of 5

Highlights for fingolimod

Oral capsule
1

Fingolimod is an oral capsule used to decrease symptom flare-ups and delay disability caused by multiple sclerosis.

2 3

Fingolimod may cause a serious decrease in your heart rate or change your heart rhythm. Talk to your doctor if you have a pre-existing heart condition or if you’re on medications that change your heart rhythm.

4

Your doctor will monitor you for 6 hours or more after your first dose so they can manage any decreases in your heart rate.

5

Common side effects include headache, flu, back pain, liver damage, diarrhea, and persistent cough.

IMPORTANT INFORMATION

May cause liver problems

Your doctor may do blood tests to check your liver before you start fingolimod. They may do additional tests if you have symptoms of liver problems. If fingolimod is damaging your liver, your doctor may stop the medication.

May change heart rate

This is especially possible after your first dose. These effects may be worse if you have a pre-existing heart condition or if you’re taking certain medications. Your heart rate will usually go back to normal within 1 month after starting fingolimod. Symptoms of a slow heart rate may include dizziness, tiredness, and feelings that your heart is beating too slowly or skipping beats.

May cause vision problems

Because of the risk of vision problems, you may have an eye exam before you start treatment with fingolimod. You may have a repeat eye exam once you have completed 3–4 months of treatment. Having a history of diabetes or uveitis increases your risk of this side effect. Call your doctor right away if you experience blurriness, shadows, or a blind spot in the center of your vision, sensitivity to light, or unusually colored vision.

May affect your lung function

Fingolimod can cause breathing problems. Your doctor may test your lung function before you begin therapy and while you’re on the medication. Call your doctor right away if you experience shortness of breath.

Drug Features

Fingolimod is a prescription drug. It’s available as an oral capsule.

Why It's Used

Fingolimod is used to treat relapsing forms of multiple sclerosis. It can decrease the number of flare-ups you experience and delay the physical disability caused by multiple sclerosis.

More Details

How It Works

Fingolimod appears to lower levels of a certain type of white blood cells in your body. These white blood cells mistake your central nervous system for a foreign substance and attack it, causing damage.

More Details

Why It's Used

Fingolimod is used to treat relapsing forms of multiple sclerosis. It can decrease the number of flare-ups you experience and delay the physical disability caused by multiple sclerosis.

Symptoms of flare-ups may include:

  • a change in vision
  • muscle weakness
  • problems with coordination and balance
  • problems with thinking and memory

How It Works

Fingolimod appears to lower levels of a certain type of white blood cells in your body. These white blood cells mistake your central nervous system for a foreign substance and attack it, causing damage. Lowering the number of these white blood cells in the central nervous system may help to slow down the damage that they cause.  

Fingolimod doesn’t cure multiple sclerosis, but it can help to decrease the symptoms and slow down physical disability caused by the disease.

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fingolimod Side Effects

Oral capsule

Most Common Side Effects

The most common side effects that occur with fingolimod include:

  • headache

  • flu

  • diarrhea

  • back pain

  • liver damage

  • cough

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • swelling and narrowing of the blood vessels in your brain. Symptoms may include:

    • sudden headache
    • confusion
    • seizures
    • loss of vision
    • weakness
  • liver damage. Symptoms may include:

    • nausea
    • vomiting
    • stomach pain
    • loss of appetite
    • tiredness
    • yellowing of your skin or the whites of your eyes
    • dark urine
  • increased risk of serious infections. Call your doctor immediately if you have symptoms of infection, such as:

    • fever
    • tiredness
    • body pains
    • chills
    • nausea
    • vomiting
  • slowed heart rate. Symptoms may include:

    • dizziness
    • tiredness
    • feelings that your heart is beating too slowly or skipping beats
  • vision problems. Symptoms may include:

    • blurriness, shadows, or a blind spot in the center of your vision
    • sensitivity to light
    • unusually colored vision
  • trouble breathing or shortness of breath

Pharmacist's Advice
Healthline Pharmacist Editorial Team

Fingolimod doesn’t cause drowsiness.

Mild side effects may disappear within a few days or a couple of weeks. Talk to your doctor or pharmacist if your side effects are more severe or don’t disappear.

Your heart rate and blood pressure may be dramatically affected after taking the first dose of fingolimod. You will likely be monitored for at least 6 hours after your first dose. You may experience:

  • dizziness
  • tiredness
  • feeling that your heart is beating slowly or skipping a beat

Your heart rate may return to normal within 1 month of starting fingolimod.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
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fingolimod May Interact with Other Medications

Oral capsule

Fingolimod may interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Medications that slow heart rate or change heart rhythm

These include:

  • calcium channel blockers:
    • diltiazem
    • verapamil
  • beta-blockers:
    • metoprolol
    • atenolol
  • digoxin

If switching medications isn’t possible, your doctor may need to monitor your heart function overnight after the first dose of fingolimod.

Ketoconazole

Combining fingolimod with ketoconazole increases the amount of fingolimod in your blood. This may increase the risk of side effects from fingolimod.

If you’re taking ketoconazole and are starting fingolimod, your doctor may monitor you closely.  

Vaccines

Vaccines might be less effective while taking fingolimod and for up to 2 months after stopping the medication. You should avoid certain live vaccines while taking fingolimod, because fingolimod lowers your immune system. Receiving these vaccines while your immune system is lowered can increase your risk of infection.

Live vaccines include:

  • the nasal spray flu vaccine
  • chickenpox vaccine
  • measles, mumps, and rubella vaccine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with heart disorders

Because fingolimod can affect the rate of your heartbeat, you shouldn’t take fingolimod if you’ve had serious heart problems in the last 6 months. These may include:

  • heart attack
  • unstable angina
  • stroke
  • signs of a stroke
  • certain types of heart failure
  • an irregular or abnormal heartbeat
  • taking certain medications that change your heart rhythm

Pregnant women

Fingolimod is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Fingolimod takes approximately 2 months to clear from your body. There are possible risks to your fetus from taking this medication during this time. If you’re a female who can become pregnant, you should use effective birth control while taking fingolimod and for at least 2 months after stopping.

Tell your doctor if you’re pregnant or plan to become pregnant. Fingolimod should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus.

Women who are nursing

It isn’t known if fingolimod passes through breast milk. You should discuss with your doctor the risks to your baby if you breastfeed while taking fingolimod. It isn’t advised to breastfeed while you’re taking this medication.

For Seniors

Fingolimod has been studied in a small number of people older than 65 years. People in this age range may have a higher chance of decreased liver or kidney function, which could affect how the medication works. If you’re older than 65 years, use this medication with caution.

For Children

The safety and effectiveness of fingolimod haven’t been established in people younger than 18 years.

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How to Take fingolimod (Dosage)

Oral capsule

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Multiple sclerosis (MS)

Brand: Gilenya

Form: Oral Capsule
Strength: 0.5 mg
Adult Dosage (ages 18 years and older)

The dose is 0.5 mg taken once per day.

Child Dosage (ages 0-17 years)

Dosing information for children hasn’t been established.

Special considerations

Liver disease: No dose adjustment is needed for mild or moderate liver disease. If you have severe liver disease, such as cirrhosis, your doctor should monitor you closely.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Fingolimod comes with risks if you don’t take it as prescribed by your doctor.

If You Don’t Take It at All

Your multiple sclerosis can worsen over time. Multiple sclerosis is active in your body and can damage your nervous system even if you aren’t experiencing symptoms. Taking this drug can help slow the damage.

If You Stop Taking It

Taking this drug helps to slow the damage that multiple sclerosis does to your nervous system. Stopping the drug allows the damage to happen more quickly.

If You Take Too Much

Call your doctor or go to the nearest hospital emergency room. Fingolimod can cause your heart rate to slow significantly. If you take too much, you’ll need to be observed overnight with heart monitoring in a hospital.

What To Do If You Miss a Dose

If you forget to take your dose, call your doctor. You may need to be observed by your doctor for at least 6 hours when you take your next dose in case you experience a decreased heart rate. 

Missing doses or not taking it as scheduled can change the amount of the drug in your body from day to day and reduce its effectiveness.

How to Tell if the Drug Is Working

You can tell fingolimod is working if you experience a decrease in multiple sclerosis flare-ups.

Fingolimod is a long-term drug treatment.

Important Considerations for Taking Fingolimod

Store in temperatures from 59–86°F (15–30ºC)

Store fingolimod in the original bottle or blister pack. Keep it away from light and high temperatures.

Keep fingolimod away from areas where it could get wet, such as bathrooms. Store it away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original prescription-labeled bottle with you when traveling.

Clinical Monitoring

Heart rate and blood pressure: Your doctor will monitor your heart rate and blood pressure after your first dose and periodically during treatment. 

Infection: Fingolimod may increase your risk of infections. Your doctor may look at blood test results before you start treatment. Your doctor will monitor you for infection during treatment and for 2 months after you stop treatment. 

Vision: Because of the risk of vision problems, you may have an eye exam before you start treatment with fingolimod. You may have a repeat eye exam once you’ve completed 3–4 months of treatment. Having a history of diabetes or uveitis increases your risk of this side effect. Call your doctor right away if you experience blurriness, shadows, or a blind spot in the center of your vision, sensitivity to light, or unusually colored vision.

Lung function: Fingolimod may affect your lung function. Your doctor may test your lung function before you begin therapy and while you’re on the medication. Fingolimod can cause breathing problems. Call your doctor right away if you experience shortness of breath.

Liver function: Your doctor may check your liver function with blood tests before you start treatment and periodically while you’re on treatment. If your liver tests show signs of liver injury, your doctor may tell you to stop treatment with fingolimod.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for fingolimod.

Are There Any Alternatives?

There are several drugs that can treat multiple sclerosis. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

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How Much Does fingolimod Cost?

Oral capsule
We've partnered with GoodRX so you can compare prices and save money on your next prescription. Check out the lowest cash prices below and enter your zip code to find the best deal near you.

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Lowest price for fingolimod

Membership warehouse $5,505.00
Publix $5,524.20
Kroger Pharmacy $5,526.76
These represent the lowest cash prices for fingolimod and may be lower than your insurance.

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These represent the lowest cash prices for fingolimod and may be lower than your insurance.

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on April 8, 2015

Disclaimer: Healthline 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 other 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.

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