You should not use Gilenya if you have a serious heart condition. This includes severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), taking certain heart rhythm medicines, or a recent heart attack, stroke, chest pain, or other serious heart problem.
Fingolimod can slow your heart rate. You will receive your first dose in a hospital setting where your heart rhythm can be monitored.
Gilenya affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, increased sensitivity to light, or problems with speech, thought, vision, or muscle movement.
Before taking this medicine
You should not use Gilenya if you are allergic to fingolimod, or if you have certain serious heart conditions, especially:
severe heart failure (that required you to be in the hospital);
"AV block" or sick sinus syndrome (unless you have a pacemaker);
long QT syndrome; or
recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.
Some heart rhythm medications can cause unwanted or dangerous effects when used with fingolimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, flecainide, dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, or sotalol.
Before you take Gilenya, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking this medicine.
Tell your doctor if you have ever had:
an active or chronic infection;
a heart rhythm disorder;
chest pain (angina) or other heart problems;
a heart attack or stroke, including "mini-stroke";
high or low blood pressure;
fainting spells;
diabetes;
skin cancer;
liver disease;
an eye condition called uveitis; or
asthma, sleep apnea, or other breathing disorder.
Using Gilenya may increase your risk of developing skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.
Fingolimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 2 months after your last dose. Tell your doctor if you become pregnant during this time.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fingolimod on the baby.
It may not be safe to breastfeed while using fingolimod. Ask your doctor about any risk.
How should I take Gilenya?
Take Gilenya exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using Gilenya.
Fingolimod can slow your heart rate. You will receive your first dose in a hospital setting. Your blood pressure and heart rate will be constantly monitored for at least 6 hours after your first dose of Gilenya.
You may take Gilenya with or without food.
If you stop taking Gilenya, do not start taking it again without asking your doctor. You will need to be under medical observation when you restart this medication
Always ask your doctor before you stop taking Gilenya for any reason. When you stop taking this medicine, your MS symptoms may return. In rare cases, some people who stopped taking fingolimod had MS symptoms that were worse than before or during treatment with this medicine.
If you stop taking Gilenya, watch for signs of worsening MS for at least 12 weeks after your last dose. Call your doctor right away if any new or worsening symptoms appear.
Gilenya affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last up to 2 months after you stop taking this medicine.
Store in the original package at room temperature away from moisture and heat.
