"April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to"...
Gilenya Patient Information including How Should I Take
In this Article
- What is fingolimod (Gilenya)?
- What are the possible side effects of fingolimod (Gilenya)?
- What is the most important information I should know about fingolimod (Gilenya)?
- What should I discuss with my healthcare provider before taking fingolimod (Gilenya)?
- How should I take fingolimod (Gilenya)?
- What happens if I miss a dose (Gilenya)?
- What happens if I overdose (Gilenya)?
- What should I avoid while taking fingolimod (Gilenya)?
- What other drugs will affect fingolimod (Gilenya)?
- Where can I get more information?
What should I discuss with my healthcare provider before taking fingolimod (Gilenya)?
You should not use fingolimod if you are allergic to it, 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);
- a recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem; or
- if you take any of these heart rhythm medications -- amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), dronedarone (Multaq), ibutilide (Corvert), mexiletine (Mexitil), procainamide (Procan, Pronestyl), propafenone, (Rythmol), quinidine (Quin-G), or sotalol (Betapace).
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 history of Long QT syndrome;
- 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.
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 blood pressure and 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.
Additional Gilenya Information
- Gilenya Drug Interactions Center: fingolimod oral
- Gilenya Side Effects Center
- Gilenya Overview including Precautions
- Gilenya FDA Approved Prescribing Information including Dosage
Gilenya - User Reviews
Gilenya User Reviews
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