Fingolimod belongs to the class of medications called sphingosine 1-phosphate (S1P) receptor modulators. It is used to treat the relapsing-remitting form of multiple sclerosis (MS).
Fingolimod does not cure MS, but it helps to reduce the number of attacks (relapses) that occur, reduce inflammation in the brain (brain lesions seen on MRI scans), and slow the buildup of physical problems due to MS (disability progression). It is generally used for people who have not responded well to, or cannot tolerate, one or more of the other treatments for MS.
Fingolimod works by lowering the number of white blood cells (lymphocytes) in your blood by preventing them from moving freely within the body. In MS, when lymphocytes reach the brain and spinal cord, they are thought to cause the inflammation that contributes to loss of the protective sheath (called myelin) that normally covers the nerve fibres and ensures that they work properly. Fingolimod may keep these cells from reaching the brain and spinal cord.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Each capsule with a white opaque body and bright yellow opaque cap, with "FTY 0.5 mg" imprinted in black ink, and two bands imprinted on the body with yellow ink, contains 0.5 mg of fingolimod. Nonmedicinal ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, and yellow iron oxide.
The usual dose is 0.5 mg once a day, taken by mouth with half a glass of water. Fingolimod can be taken with or without food.
Fingolimod will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and side effects may still occur.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take the next dose as planned. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
If you have been taking this medication for less than 2 weeks and you forget to take a dose for one day or more, or if you stop taking fingolimod for more than 7 days after 3 or 4 weeks of treatment, contact your doctor as soon as possible. Your doctor may choose to monitor you for heart and blood pressure effects before you restart the medication.
If this medication is stopped for more than 2 weeks, contact your doctor. It will be necessary to be monitored for heart and blood pressure effects again when you restart the medication.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g., down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not take fingolimod if you:
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Health Canada has issued new information concerning the use of fingolimod. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Blood pressure: Fingolimod may also increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Breathing disorders: Fingolimod may affect lung function in people with respiratory problems such as pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease. If you have respiratory problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor if you experience any new or worsening shortness of breath.
Cancer: Fingolimod reduces the number of cells that fight infection in the body (white blood cells). This may increase your risk of developing infections and certain types of skin cancer and lymphoma (cancer of the lymph nodes).
While you are taking fingolimod, it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.
Eye problems: People who have diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. It is recommended that you have an eye examination after taking this medication for 3 or 4 months to check for changes in your eyes that have not caused symptoms. Report any changes in vision to your doctor as soon as possible.
Heart problems: Fingolimod causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start this medication. You will also need to be observed in a doctor’s office or clinic for 6 hours after your first dose. This allows the doctor to monitor your heart rate and treat any problems before they become an emergency. It may be necessary to be monitored for a longer period of time if you develop very low heart rate or an arrhythmia. People with certain heart conditions such as heart arrhythmias, angina, congestive heart failure or a history of heart attack, should not take fingolimod. Fingolimod may also cause mild increases in blood pressure.
If you have a heart problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart rhythm: This medication can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infections: Fingolimod works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking fingolimod may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause fingolimod to build up in the body, causing side effects. This medication may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using fingolimod. PML is a rare viral infection that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes or difficulty walking, contact your doctor immediately.
Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using fingolimod. If you have had a previous episode of PRES, this may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, nausea, vomiting, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.
Vaccines: If you have not had chickenpox or been vaccinated against chickenpox talk to your doctor about receiving the chickenpox (Varicella zoster) vaccine at least 1 month before starting fingolimod treatment. During and for up to 2 months after stopping treatment with fingolimod, some vaccines containing live viruses may result in the infection that the vaccination should prevent, while other vaccines may not work well enough to protect you. Talk to your doctor about which vaccinations you need before starting treatment, and which vaccines to avoid during treatment.
Pregnancy: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. Women of childbearing age who are taking fingolimod should use an effective method of birth control (e.g., birth control pill, condoms) during treatment, and for 2 months after stopping treatment with fingolimod.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking fingolimod, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors may be more at risk of side effects from this medication.
There may be an interaction between fingolimod and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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