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Safety Issues With Gilenya

Specific Precautions and Warnings With Gilenya

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Gilenya has a tendency to lower the heart rate, especially after the first dose. Because this can occasionally be dangerous in some individuals, you will begin Gilenya treatment in a medical facility. Your healthcare provider will check the electrical activity of your heart, with an electrocardiogram (ECG), before you start Gilenya, and then monitor your heart rate and blood pressure every hour for at least six hours after you take your first dose. Six hours after your first dose, you will have another ECG.

If you experience serious side effects, you will need to be monitored overnight, and again for at least six hours after you take your second Gilenya dose. People with certain types of heart problems or who take certain medications that affect the heart will automatically be monitored overnight after taking their first Gilenya dose.


Typically, your heart rate will return to normal within the first month while taking Gilenya. You will need to follow these same first-dose precautions again if you stop taking this medicine for more than a day during your first two weeks of treatment, more than seven days during your second or third weeks of treatment, or two weeks or longer any time thereafter.

  • Gilenya decreases the body's ability to fight infections. In rare cases, this can result in life-threatening infections. You should contact your healthcare provider right away if you develop any signs or symptoms of an infection (such as a fever).  
  • If you have never had chickenpox and have not had the chickenpox vaccine, your healthcare provider should run a blood test to see if you are susceptible to this infection. You may need to receive the chickenpox vaccine and wait one month before starting Gilenya. Getting chickenpox while on Gilenya can be quite serious.
  • Gilenya can cause swelling of the macula of the eye (macular edema). If you have diabetes or uveitis, you have a higher risk for this side effect of Gilenya. Your healthcare provider should test your vision before you start this medication and again three to four months later. Let your healthcare provider know if you develop any vision changes.
  • Gilenya can decrease your lung capacity and cause shortness of breath. Let your healthcare provider know if you develop any breathing difficulties.
  • Gilenya can cause high liver enzymes (found using a blood test). Because your healthcare provider will need to know your "baseline" levels (in case you develop possible liver problems), your liver enzymes should be tested before you start this medication. This is a simple and common blood test. Let your healthcare provider know if you develop signs of liver problems, such as abdominal pain, nausea and vomiting, fatigue, loss of appetite, dark urine, or yellowing of the skin or whites of the eyes (jaundice).
  • Gilenya can raise blood pressure. Your healthcare provider should monitor your blood pressure regularly.



  • Gilenya is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are unknown (see Gilenya and Pregnancy).
  • It is unknown if Gilenya passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, discuss this with your healthcare provider prior to taking the drug (see Gilenya and Breastfeeding).
Know the Signs - Concussion Safety

Gilenya Medication Information

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