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Fingolimod is used to treat multiple sclerosis. It works by targeting a type of immune cell called lymphocytes, reducing the frequency of multiple sclerosis relapses. Common side effects include headache, changes in liver function tests, diarrhea, cough, flu, sinus infections, back pain, stomach pain, and pain in the arms or legs. Fingolimod is available as a capsule that is swallowed and a tablet that dissolves in the mouth.

Uses

What is fingolimod used for?

Fingolimod is commonly used to treat multiple sclerosis (MS). MS is a chronic condition where the immune system attacks and damages the protective coating around nerve cells, making it harder for the brain and body to work together. This can cause symptoms like trouble walking, fatigue, muscle weakness, numbness, and vision and memory problems. Fingolimod can treat the following relapsing forms of MS. 

  • Clinically isolated syndrome (CIS)
  • Relapsing-remitting MS (RRMS)
  • Active secondary progressive MS (SPMS)

Fingolimod may also be used for other conditions as determined by your health care provider.

How does fingolimod work (mechanism of action)?

Fingolimod works by targeting immune cells called lymphocytes. These cells play a key role in the inflammatory process in the central nervous system. Fingolimod helps reduce the frequency of multiple sclerosis relapses.

How is fingolimod supplied (dosage forms)?

Brands and other names

  • Gilenya
  • Tascenso ODT

Dosage forms and strengths

  • 0.25 mg, 0.5 mg oral capsules
  • 0.25 mg, 0.5 mg orally disintegrating tablets

How should I store fingolimod?

Oral Capsule. Fingolimod should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place and protect from moisture.

Orally Disintegrating Tablet. Fingolimod should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place and protect from moisture. Store the orally disintegrating tablets in the sealed blister pack, and do not open until you are ready to use.

Side Effects

What are the most common side effects of fingolimod?

The most common side effects of fingolimod are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Changes in liver function tests
  • Diarrhea
  • Cough 
  • Flu
  • Sinus infections
  • Back pain
  • Stomach pain
  • Pain in the arms or legs

There may be other side effects of fingolimod that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of fingolimod?

While less common, the most serious side effects of fingolimod are described below, along with what to do if they happen.

Heart Rate Changes. When you start taking fingolimod, especially after the first dose, your heart rate may be slower than normal (bradycardia). You will have an electrocardiogram (ECG) before starting therapy. This is a common test to monitor the rate and rhythm of your heart. Your health care provider will also monitor you after your first dose of fingolimod. Call your health care provider right away if you have any of the following symptoms of bradycardia.

  • Feeling lightheaded, dizziness, or fainting
  • Confusion
  • Feeling weak or easily tired
  • Chest pain
  • Shortness of breath
  • Feeling your heart beat slower or skipping a beat

Severe Allergic Reactions. Fingolimod may cause allergic reactions, which can be serious. Stop taking fingolimod and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Fingolimod can increase the risk of infection, including serious infections that can be life-threatening. This risk can last up to two months after you stop taking fingolimod. Your health care provider will check your white blood cell levels before and during treatment. Do not get a live vaccine while taking fingolimod and for two months after the last dose. Check with your health care provider before getting any vaccines during treatment with fingolimod and for two months after the last dose. Call your health care provider if you have an infection or any of the following symptoms during treatment with fingolimod and for two months after the last dose.

  • Burning or stinging when you pee
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Headache and a stiff neck, with fever, light sensitivity, nausea, or confusion (may be symptoms of an infection of the lining around your brain and spine)

Progressive Multifocal Leukoencephalopathy (PML). People taking fingolimod may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop taking fingolimod and call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness, loss of coordination, or balance problems
  • Decreased strength
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Confusion
  • Weakness on one side of your body that gets worse
  • Seizures

Vision Problems. Fingolimod may increase your risk of macular edema. Macular edema happens when fluid builds up in the back of your eye. People with eye inflammation (uveitis) or diabetes may have a higher risk of macular edema while taking fingolimod. Keep any scheduled eye exams before starting or while taking fingolimod. Call your health care provider right away if you have any of the following symptoms of macular edema.

  • Blurriness or shadows 
  • Sensitivity to light
  • Worsening vision
  • A blind spot in the middle of your vision
  • Dull or unusually colored or tinted vision

Posterior Reversible Encephalopathy Syndrome (PRES). Fingolimod may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision 
  • Sudden severe headache
  • Seizures

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking fingolimod. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Breathing Problems. Fingolimod may cause shortness of breath (dyspnea), which can be serious. Call your health care provider right away if you have new or worsening breathing problems.

Severe Worsening of Multiple Sclerosis Symptoms After Stopping Treatment. When stopping fingolimod, symptoms of multiple sclerosis (MS) may return. These symptoms may be worse than they were before or during treatment with fingolimod. Do not stop taking fingolimod unless directed by your health care provider. Call your health care provider if your MS symptoms worsen after you stop taking fingolimod.

Increased Blood Pressure (Hypertension). Fingolimod may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

Skin Cancer. Fingolimod may increase your risk of skin cancer, such as basal cell carcinoma, melanoma, and squamous cell carcinoma. Limit the amount of time you spend in the sun while taking fingolimod. Wear protective clothing and use sunscreen with a high sun protection factor. Keep any appointments to have your skin checked while taking fingolimod. Tell your health care provider if you notice any of the following symptoms of skin cancer.

  • Changes in a mole on your skin
  • A new darkened area on your skin
  • A sore that does not heal
  • Growths on your skin, such as a bump

Warnings & Precautions

Who should not use fingolimod?

Allergies to Ingredients. People who are allergic to any of the following should not take fingolimod.

  • Fingolimod
  • Gilenya
  • Tascenso ODT
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific fingolimod products they stock.

Heart Rhythm Problems. You should not take fingolimod if you have any of the following heart rhythm problems.

  • Complete heart block (third degree) or Mobitz type II second-degree atrioventricular (AV) block (unless you have a working pacemaker)
  • Sick sinus syndrome (unless you have a working pacemaker)
  • Heart rhythm problems that require you to take certain drugs
  • Prolonged QTc interval 

Heart Problems. You should not take fingolimod if you have had any of the following heart problems in the last six months.

Drug Interactions. Fingolimod should not be taken while you are using certain other medicines. Before taking fingolimod, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about fingolimod before using it?

Do not take fingolimod unless it has been prescribed to you by a health care provider. Take it as prescribed. Make sure that you understand how to properly take fingolimod. If you have any questions, talk to your health care provider.

Do not share fingolimod with other people, even if they have the same condition as you. It may harm them.

Keep fingolimod out of the reach of children.

Fingolimod can cause your heart rate to slow down, especially after the first dose. Your health care provider will monitor you for at least six hours after you take the first dose. Also, children who take fingolimod and have their dose increased will need to be monitored. If you have certain medical conditions or serious side effects after the first dose, your health care provider will recommend you stay in the facility overnight for observation, and you will also be monitored for at least six hours after your second dose. 

Your health care provider will order blood tests before and during treatment with fingolimod. Keep all appointments for follow up and blood tests. 

Some people have reported human papilloma virus (HPV) infections while taking fingolimod. Talk to your health care provider to ensure your HPV vaccine is up to date and ask about preventive screenings.

Do not stop taking fingolimod without talking to your health care provider. When fingolimod is stopped, your multiple sclerosis symptoms may return and be worse than before starting treatment. If your symptoms become worse, talk to your health care provider.

What should I tell my health care provider before using fingolimod?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if fingolimod is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Irregular or abnormal heartbeat
  • History of stroke or mini stroke
  • Heart problems, including heart attack or angina (chest pain)
  • A history of fainting
  • Fever, infection, or a weak immune system
  • Breathing problems, including during sleep (sleep apnea)
  • Chickenpox infection or have received the chickenpox vaccine
  • Liver problems
  • Diabetes
  • Eye problems, such as inflammation of the eye (uveitis)
  • High blood pressure
  • Skin cancer, including basal cell carcinoma, melanoma, or squamous cell carcinoma

Vaccines. Tell your health care provider about any vaccines you have recently received or have scheduled. Also, talk to your health care provider about any vaccines that you may need. You should not receive certain vaccines right before starting treatment, while taking fingolimod, and for four weeks after stopping treatment. If your child is taking fingolimod, their vaccination schedule must be complete before starting this medicine. Talk to your child’s health care provider for more information and medical advice.

Pregnancy. Fingolimod may harm your fetus. Your health care provider will test you for pregnancy before you start taking fingolimod. Tell your health care provider if you are pregnant or plan to become pregnant or if you become pregnant while taking fingolimod or within two months of your last dose of fingolimod. You should use effective birth control while taking fingolimod and for at least two months after the last dose. You can talk to your health care provider about the best type of birth control for you. If you wish to become pregnant, you will need to stop taking fingolimod two months before you try to become pregnant.

Breastfeeding. It is not known if fingolimod passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take fingolimod while breastfeeding.

Interactions

Does fingolimod interact with foods or drinks?

There are no known interactions between fingolimod and foods or drinks.

It is unknown if drinking alcohol will affect fingolimod, but both fingolimod and alcohol can cause liver damage. It is likely best to limit the amount of alcohol you drink while taking fingolimod.

Does fingolimod interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking fingolimod.

  • Any other medicine that contains the active ingredient fingolimod
  • Any cancer medicines
  • Any medicine that affects the immune system, including mitoxantrone, natalizumab (Tyruko, Tysabri), or teriflunomide (Aubagio) 
  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions, asthma, or COPD
  • Ketoconazole, which is a medicine used for fungal infections
  • Citalopram (Celexa), which is a medicine used for depression
  • Chlorpromazine, which is a medicine that may be used to treat certain mental health conditions or severe nausea and vomiting
  • Haloperidol, which is a medicine used to treat certain mental health conditions 
  • Methadone, which is an opioid medicine used to treat pain or opioid use disorder
  • A calcium channel blocker, such as diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
  • A beta-blocker, such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL, and others), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to lower blood pressure
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections

Some other medicines may alter the blood levels of fingolimod. Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with fingolimod. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much fingolimod?

If you or someone else has used too much fingolimod, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of fingolimod?

Call your health care provider if you miss a dose of fingolimod. If you miss one or more doses, you may need to be monitored by a health care provider when you take the next dose. 

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