"The European Medicines Agency (EMA) today issued updated recommendations on ways to minimize the risk for progressive multifocal leukoencephalopathy with dimethyl fumarate (Tecfidera, Biogen).
To date, three cases of PML have"...
Gilenya Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
This medication can affect your immune system's ability to fight an infection while you are taking the medication and for 2 months after your last dose. You may be more likely to get a serious infection (such as bronchitis, pneumonia). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, or cold/flu symptoms. Do not start fingolimod if you have a current infection.
Get medical help right away if you have any very serious side effects, including: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular/fast heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes), clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty moving muscles, seizure, sudden/severe headache, problems with speech.
This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: yellowing eyes/skin, dark urine, stomach/abdominal pain, persistent nausea.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Gilenya (fingolimod capsules) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also How to Use section.
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), high blood pressure, liver disease, stroke or "mini-stroke"/transient ischemic attack (TIA).
Do not have immunizations/vaccinations while you are taking fingolimod and for 2 months after your last dose without the consent of your doctor. Also, avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose and people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Fingolimod is not recommended for use during pregnancy. It may harm an unborn baby. Discuss with your doctor the use of reliable forms of birth control while taking this medication and for 2 months after your last dose. If you become pregnant or think you may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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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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