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What should I discuss with my healthcare provider before taking fingolimod (Gilenya)?

You should not use fingolimod if you are allergic to it.

Before you take fingolimod, 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 fingolimod.

To make sure you can safely take fingolimod, tell your doctor if you have any of these other conditions:

• an active or chronic infection;
• a very slow heart rate (fewer than 55 beats per minute);
• low blood pressure or a history of fainting;
• high blood pressure, heart disease, congestive heart failure;
• a serious heart condition such as "sick sinus syndrome," second-degree heart block or "AV block";
• a history of "Long QT syndrome";
• diabetes;
• liver or kidney disease;
• asthma or other breathing disorder; or
• history of an eye condition called uveitis.

FDA pregnancy category C. It is not known whether fingolimod will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Use effective birth control while you are using this medication and for at least 2 months after your treatment ends.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of fingolimod on the baby.

Fingolimod can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using fingolimod.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take fingolimod (Gilenya)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start taking fingolimod, your blood will need to be tested. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

You will receive your first dose of fingolimod in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. Your heart rate will be constantly monitored for at least 6 hours after your first dose of fingolimod.

You may take fingolimod with or without food.

Fingolimod can increase you risk of infection for up to 2 months after you stop taking the medicine. Call your doctor if you develop any signs of a new infection.

To be sure this medication is not causing harmful effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams.

Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.

If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medication in a hospital setting under observation.

Store in original package at room temperature away from moisture and heat.

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