"April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to"...
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Details with Side Effects
Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:
Fingolimod hydrochloride is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93.
GILENYA is provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod.
Each GILENYA 0.5 mg capsule contains the following inactive ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, yellow iron oxide.
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,...
What are the precautions when taking fingolimod capsules (Gilenya)?
Before taking fingolimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, bronchitis, emphysema, sleep apnea), current/recent/returning infection (including hepatitis and tuberculosis), diabetes, fainting, certain eye problems (macular edema, uveitis), heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG), liver disease, stroke or "mini-stroke"/transient ischemic attack (TIA).
Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.
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