Fingolimod is used to prevent episodes of symptoms and slow the worsening of disability in adults and children 10 years of age and older with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Fingolimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
Fingolimod comes as a capsule to take by mouth. It is usually taken once a day with or without food. Take fingolimod at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fingolimod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Fingolimod may cause the heartbeat to slow in adults and children, especially during the first 6 hours after you take your first dose, and after the first dose when the dose is increased in children. You will receive an electrocardiogram (ECG; test that records the electrical activity of the heart) before you take your first dose and again 6 hours after you take the dose. You will take your first dose of fingolimod in your doctor's office or another medical facility. You will need to stay at the medical facility for at least 6 hours after you take the medication so that you can be monitored. You may need to stay at the medical facility for longer than 6 hours or overnight if you have certain conditions or take certain medications that increase the risk that your heartbeat will slow or if your heartbeat slows more than expected or continues to slow after the first 6 hours. You may also need to stay at a medical facility for at least 6 hours after you take your second dose if your heartbeat slows too much when you take your first dose. Tell your doctor if you experience dizziness, tiredness, chest pain, or slow or irregular heartbeat at any time during your treatment, especially during the first 24 hours after you take your first dose.
Fingolimod may help control multiple sclerosis but will not cure it. Do not stop taking fingolimod without talking to your doctor. If you do not take fingolimod for 1 day or longer during the first 2 weeks of treatment, for 1 week or longer in the third and fourth weeks of treatment or for 2 weeks or longer after the first month of treatment, talk to your doctor before you start taking it again. You may experience slowed heartbeat when you start taking fingolimod again, so you will need to restart the medication in your doctor's office.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fingolimod and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking fingolimod,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and call your doctor before you take the next dose. You may need to be monitored as you restart your medication. Do not take a double dose to make up for a missed one.
Fingolimod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Fingolimod may increase the risk of developing skin cancer and lymphoma (cancer that begins in the cells that fight infection). Talk to your doctor about the risks of taking this medication.
A sudden increase episodes of MS symptoms and worsening of disability may occur within 3 to 6 months after you stop taking fingolimod. Tell your doctor if your MS symptoms worsen after stopping fingolimod.
Fingolimod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests, and skin and eye exams, and will monitor your blood pressure before and during your treatment to be sure that it is safe for you to begin taking or continue to take fingolimod.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fingolimod.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.