Fingolimod (Gilenya) is a disease-modifying treatment option for relapsing multiple sclerosis (MS). It works well to lower the number of MS relapses. Fingolimod (Gilenya) is taken by mouth, typically once daily, and can be used by adults and children age 10 years and older. But fingolimod (Gilenya) can cause potentially serious side effects, such as a higher risk for infections and heart problems, so it's not the best choice for everyone.
Relapsing forms of multiple sclerosis (MS)
Fingolimod (Gilenya) is a disease-modifying treatment for multiple sclerosis (MS). More specifically, it's a sphingosine 1-phosphate receptor modulator. The exact way it works to treat MS is unknown. But it's thought that fingolimod (Gilenya) lowers the number of white blood cells in your body, thus lessening the damage these cells cause to your nerves.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Blurred vision
chills
cough-producing mucus
difficult or labored breathing
dizziness
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
nervousness
pounding in the ears
seizures
shivering
slow or fast heartbeat
sweating
tightness in the chest
trouble sleeping
unusual tiredness or weakness
vomiting
Less common
Black, tarry stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
headache, severe and throbbing
hoarseness
lightheadedness, dizziness, or fainting
lower back or side pain
painful or difficult urination
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
unusual bleeding or bruising
Incidence not known
Agitation
back pain
change in size, shape, or color of existing mole
confusion
difficulty in moving
difficulty in speaking
double vision
drowsiness
epileptic seizure that will not stop
inability to move the arms, legs, or facial muscles
inability to speak
irritability
joint stiffness or swelling
loss of consciousness
mole that leaks fluid or bleeds
mood or mental changes
muscle pain, cramps, or stiffness
new mole
redness of the skin
seeing, hearing, or feeling things that are not there
slow speech
stiff neck
swelling of the eyelids, face, lips, hands, or feet
troubled swallowing
yellow skin and eyes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well in both adults and children to lower the number of MS relapses
Taken by mouth once per day
Can be used in children age 10 and older
First dose usually has to be observed for at least 6 hours
Might not be safe for pregnant or breastfeeding females
Not a good option for people with heart or liver problems
Fingolimod is available as two brands. Gilenya is a capsule that's taken by mouth and Tascenso ODT is a tablet that's dissolved on the tongue. Ask your pharmacist if you're not sure which brand you have or how to correctly take it.
If you're taking Tascenso ODT, make sure your hands are dry before handling the medication. Peel off the foil backing, and remove the tablet from the blister card. Don't try to push the tablet through the foil; this can damage the medication. Place the tablet on the tongue to let it dissolve, and swallow with saliva.
Take fingolimod (Gilenya) at the same time every day with or without food. If it's hurting your stomach, try taking it with food.
When you first start taking fingolimod (Gilenya), you might experience a temporary drop in your heart rate. Because this can be serious for some people, your provider will check your heart rate and blood pressure every hour for the first 6 hours after you take the first dose of fingolimod (Gilenya).
Your provider will perform electrocardiogram (ECG) tests before and after your first dose of fingolimod (Gilenya) to check your heart. Let your provider know if you have any heart conditions or are taking any medications that affect your heart rate. If so, your provider might ask you to stay at a medical clinic or hospital to monitor your heart overnight.
Fingolimod (Gilenya) can raise your blood pressure. Monitor your blood pressure at home or at your provider's office regularly to make sure it's within a safe range. If you notice your blood pressure going up, let your provider know.
Fingolimod (Gilenya) can interact with other medications. For example, taking fingolimod (Gilenya) with beta-blockers can cause serious heart problems. Or, taking fingolimod (Gilenya) with medications that affect your immune system could raise your risk for serious infections. Make sure to tell your provider about all the medications you're taking before starting fingolimod (Gilenya).
Don't stop taking fingolimod (Gilenya) without talking to your provider. Stopping the medication can cause your MS symptoms to come back worse than they were before you started the medication. Your provider can talk with you about what to expect if you stop this medication and how to manage your MS if your symptoms come back.
Fingolimod (Gilenya) can stay in your body for up to 2 months after you stop taking it. This means that you're still at risk for side effects from this medication, such as liver problems or higher risk of infection, during this time. Continue to avoid or limit your time around others who are sick. Also, continue to monitor yourself for symptoms of side effects from fingolimod (Gilenya) and let your provider know if you are concerned.
Fingolimod (Gilenya) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Taking other medications that affect heart rate | History of heart problems | Starting fingolimod (Gilenya) | Restarting fingolimod (Gilenya) after being off of it for awhile
Fingolimod (Gilenya) can cause a temporary drop in heart rate within the first 24 hours of starting this medication, which can be dangerous. Let your provider know if you've any heart-related conditions or if you're taking medications that also affect heart rate. Your care team will monitor your heart for at least 6 hours after your first dose of fingolimod (Gilenya), depending on what other health conditions you have. Seek medical help if you have symptoms of low heart rate while taking fingolimod (Gilenya), such as fatigue, weakness, confusion, feeling faint, trouble breathing, and chest pain.
Risk factors: Active, chronic (long term), or recurrent infection | Age 65 years and older | Having other conditions that raise your risk of infection | Taking medications that weaken your immune system
Fingolimod (Gilenya) can affect your body's ability to fight off infections, which can raise your risk of serious bacterial, viral, or fungal infections. Make sure you're up-to-date on all of your vaccinations before starting fingolimod (Gilenya). If you develop an infection while on treatment, your provider will likely ask you to stop taking fingolimod (Gilenya) so your body can fight the infection first. Let your provider know if you develop symptoms of an infection, such as fever, cough, difficulty breathing, diarrhea, or chills.
Risk factors: Taking fingolimod (Gilenya) for a long time (longer than 2 years) | Taking medications that weaken your immune system
Fingolimod (Gilenya) can put you at risk of getting progressive multifocal leukoencephalopathy (PML). This is a brain infection caused by the John Cummingham virus (JCV). Though it's a common virus, people who get infected with JCV usually don't experience any symptoms. But in people who have a weakened immune system, JCV can cause PML, which can lead to death or severe disability. Seek medical attention right away and get tested for PML if you experience weakness on one side of the body, feel clumsy, or notice changes in personality, vision, or memory.
Risk factors: Diabetes | History of eye inflammation (uveitis)
Fingolimod (Gilenya) raises your risk of an eye condition called macular edema. Your provider will examine your eyes before and during treatment. Make sure you let them know if you start to have blurry or worsening vision.
Though rare, fingolimod (Gilenya) can cause serious liver problems. This can happen as early as 10 days after you start treatment. Your provider will ask you to do blood work to check your liver health before you start and during fingolimod (Gilenya) treatment. If your liver labs are outside of the safe range, your provider might ask you to stop taking this medication. Typically, your liver labs should return to the normal range after you stop fingolimod (Gilenya). Get medical attention right away if you notice symptoms of liver damage, such as swelling of your stomach, yellowing of your skin or the whites of your eyes, dark urine, or pale stool.
Risk factors: History of lung problems
Fingolimod (Gilenya) can cause breathing problems. This can happen as early as 1 month after you start the medication. If you have a history of lung problems and are prescribed a rescue inhaler, make sure to always keep it with you. Let your provider know if you have trouble breathing because you might need to stop fingolimod (Gilenya) and get more medical attention.
Based on animal studies, it's possible that fingolimod (Gilenya) can harm unborn babies when taken during pregnancy. Females of childbearing age should use birth control and avoid pregnancy during treatment and for at least 2 months after the last dose of fingolimod (Gilenya). Let your provider know right away if you become pregnant or think you might be pregnant while taking fingolimod (Gilenya).
Though not common, fingolimod (Gilenya) might raise your risk of getting certain types of cancers, including blood or skin cancer. You'll likely need certain labs and regular physical exams while you take fingolimod (Gilenya) to monitor your risk of cancer. Contact your provider if you experience symptoms such as swollen lymph nodes, tiredness, weight loss, loss of appetite, nosebleeds, or skin changes.
Although rare, there have been reports of a brain problem called posterior reversible encephalopathy syndrome (PRES) in people taking fingolimod (Gilenya). Contact your provider right away if you notice a sudden headache, seizures, loss of consciousness, or changes in vision.
Adults and children ages 10 years and older weighing more than 88 lbs: The typical dose is 0.5 mg by mouth once daily.
Children ages 10 years and older weighing 88 lbs or less: The typical dose is 0.25 mg by mouth once daily.
If you're taking Tascenso (fingolimod) orally disintegrating tablet (ODT), you must dissolve it under the tongue.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Recent heart attack, chest pain, stroke, or heart failure within the last 6 months
History or presence of certain heart rate or rhythm problems (e.g., AV block, sick sinus syndrome)
Taking certain heart rhythm medications
Relapsing forms of multiple sclerosis (MS)
Relapsing forms of multiple sclerosis (MS)
Relapsing forms of multiple sclerosis (MS)
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