"Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
Gilenya Patient Information Including Side Effects
Brand Names: Gilenya
Generic Name: fingolimod (Pronunciation: fin GOE li mod)
- What is fingolimod (Gilenya)?
- What are the possible side effects of fingolimod (Gilenya)?
- What is the most important information I should know about fingolimod (Gilenya)?
- What should I discuss with my healthcare provider before taking fingolimod (Gilenya)?
- How should I take fingolimod (Gilenya)?
- What happens if I miss a dose (Gilenya)?
- What happens if I overdose (Gilenya)?
- What should I avoid while taking fingolimod (Gilenya)?
- What other drugs will affect fingolimod (Gilenya)?
- Where can I get more information?
What is fingolimod (Gilenya)?
Fingolimod is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they can't reach the central nervous system (brain and spinal cord).
Fingolimod is used to treat relapsing multiple sclerosis (MS) in adults. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
Fingolimod may also be used for purposes not listed in this medication guide.
What are the possible side effects of fingolimod (Gilenya)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- slow heart rate, dizziness, feeling very weak or tired;
- chest pain, pounding heartbeats or fluttering in your chest;
- sudden numbness or weakness, severe headache, problems with speech or walking;
- wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;
- fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;
- swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod).
Less serious side effects may include:
- headache, tired feeling;
- back pain;
- diarrhea; or
- stuffy nose, sinus pain, or cough.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Gilenya (fingolimod capsules) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about fingolimod (Gilenya)?
You should not use fingolimod if you are allergic to it, or if you have certain serious heart conditions, especially severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), if you take certain heart rhythm medicines, or if you have recently had a heart attack, stroke (including "mini-stroke"), chest pain (unstable angina), or other serious heart problem.
Before you take fingolimod, tell your doctor if you have an infection, a very slow heart rate, low blood pressure or a history of fainting, high blood pressure, diabetes, liver or kidney disease, asthma or other breathing disorder, congestive heart failure, heart rhythm disorder, a serious heart condition, or if you have ever had an eye condition called uveitis.
Also tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax).
You will receive your first dose of fingolimod in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. Your blood pressure and heart rate will be constantly monitored for at least 6 hours after your first dose of fingolimod.
To be sure this medication is not causing harmful effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams.
Tell your doctor if you use any heart or blood pressure medications. Do not receive a "live" vaccine while using fingolimod.
Do not stop taking fingolimod without first talking to your doctor. Stopping suddenly may make your condition worse. If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medication in a hospital setting under observation.
Additional Gilenya Information
- Gilenya Drug Interactions Center: fingolimod oral
- Gilenya Side Effects Center
- Gilenya Overview including Precautions
- Gilenya FDA Approved Prescribing Information including Dosage
Gilenya - User Reviews
Gilenya User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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