What is Gilenya?Gilenya is used to treat relapsing forms of multiple sclerosis (MS) in adults. Gilenya can decrease the number of MS flare-ups (relapses). Gilenya does not cure MS, but it can help slow down the progression of physical problems that MS causes.
What is the most important information I should know about Gilenya?Contact your doctor immediately if you have dizziness, tiredness, or a slow or irregular heartbeat. Gilenya may cause a slow heart rate when you start taking it, especially after the first dose. Your heart rate will usually slow down the most about 6 hours after you take your first dose. Your doctor will watch you for 6 hours after you take the first dose to see if you have any serious side effects. A slow heart rate will usually return to normal within 1 month after starting treatment with Gilenya. the number of white blood cells in your blood, and this usually goes back to normal within 2 months of stopping treatment. Your doctor may do a blood test before you start Gilenya. Also, some vaccines should be avoided during treatment with Gilenya and for 2 months after stopping Gilenya; talk to your doctor about your vaccination history. You may need to get the chickenpox vaccine and then wait 1 month before you start Gilenya. Contact your doctor right away if you have these symptoms of an infection: body aches, chills, fever, nausea, tiredness, or vomiting.
Gilenya may cause a problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as an MS attack. You may not notice any symptoms. Macular edema usually starts in the first 3-4 months after you start Gilenya. Your doctor should test your vision before you start and 3-4 months after you start Gilenya, or any time you notice vision changes. Your risk is higher if you have diabetes or have had an inflammation of your eye called uveitis. Contact your doctor right away if you have blurriness or shadows in the center of your vision, a blind spot in the center of your vision, sensitivity to light, or unusually colored (tinted) vision.
You may have shortness of breath while taking Gilenya. Call your doctor right away if you have trouble breathing.
Gilenya may cause liver problems. Your doctor should do blood tests to check your liver before you start Gilenya. Contact your doctor right away if you have these symptoms of liver problems: dark urine, loss of appetite, nausea, vomiting, stomach pain, tiredness, or yellowing of your skin/eyes.
Gilenya remains in the blood and continues to have effects for up to 2 months following the last dose.
Who should not take Gilenya?Children <18 years old should not take Gilenya.
What should I tell my doctor before I take the first dose of Gilenya?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Gilenya. Also, talk to your doctor about your complete medical history, especially if you have abnormal/irregular heart rate (arrhythmia), breathing problems, diabetes, eye problems including uveitis, fever/infection or an inability to fight infections, heart problems, a heart rate less than 55 beats a minute, high blood pressure, a history of chickenpox/chickenpox vaccination, a history of fainting, and liver problems.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: Your first dose will be given in a doctor's office or clinic, where you will be observed for side effects for 6 hours. If you restart therapy after stopping for 2 weeks or more, you will have to take the first dose in your doctor's office or clinic. The recommended dose is 0.5 milligram once a day.
How should I take Gilenya?Take Gilenya exactly as prescribed. You can take it with or without food.
What should I avoid while taking Gilenya?Avoid stopping Gilenya without consulting your doctor first.
What are possible food and drug interactions associated with Gilenya?If Gilenya is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Gilenya with the following: medicines for heart problems or high blood pressure, ketoconazole, medicines for cancer or to control the immune system, other medicines that could increase the chances of an infection, and vaccines.
What are the possible side effects of Gilenya?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: abnormal liver tests, back pain, cough, diarrhea, flu, headache
Can I receive Gilenya if I am pregnant or breastfeeding?Gilenya may harm your unborn baby. Tell your doctor immediately if you become pregnant while taking Gilenya or if you become pregnant within 2 months after you stop taking it. Women should use effective birth control during treatment and for at least 2 months after stopping Gilenya. If you become pregnant while taking Gilenya, talk to your doctor about registering with the Gilenya Pregnancy Registry. You should not breastfeed while taking Gilenya. Tell your doctor immediately if you are breastfeeding or plan to breastfeed.
What should I do if I miss a dose of Gilenya?If you miss a dose of Gilenya, take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.
How should I store Gilenya?Store at room temperature in the original blister pack and in a dry place.
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