[Posted 12/20/2012] ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of fingolimod (Gilenya). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.
BACKGROUND: Fingolimod is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Fingolimod is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
RECOMMENDATION: At this time, FDA continues to believe that fingolimod provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe fingolimod follow the recommendations in the approved drug label. Patients with MS should not stop taking fingolimod without talking to their healthcare professional.
FDA will communicate any new information on fingolimod and this case when it becomes available. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Fingolimod is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing 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.
You will take your first dose of fingolimod in your doctor's office. You will need to stay at the office for 6 hours after you take the medication so that you can be monitored. Fingolimod may cause your heartbeat to slow, especially during the first 6 hours after you take your first dose. Tell your doctor if you experience dizziness, tiredness, or slow or irregular heartbeat during this time.
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 2 weeks or longer, 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 take your first dose 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) 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.
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 continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
headache
weakness
back pain
numbness, burning, or tingling in the hands or feet
depression
dry, peeling, or itchy skin
hair loss
slow or pounding heartbeat
chest pain
excessive tiredness
dizziness
fainting
sore throat, fever, chills, cough, and other signs of infection
eye pain
blurriness, shadows, or a blind spot in the center of your vision
sensitivity to light
unusual color to your vision
shortness of breath
nausea
vomiting
loss of appetite
stomach pain
yellowing of the skin or eyes
dark urine
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 [at http://www.fda.gov/Safety/MedWatch] 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
chest tightness or discomfort
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests 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.
Last Revised - 02/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.