For doctors
What is it and how is it used?
What Gilenya is
The active substance of Gilenya is fingolimod.

What Gilenya is used for
Gilenya is used in adults to treat relapsing-remitting multiple sclerosis (MS), more specifically in: Patients who have failed to respond despite treatment with beta-interferon (another MS treatment). or
Patients who have rapidly evolving severe MS.

Gilenya does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

What is multiple sclerosis
MSis a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This is called demyelination.

Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS. Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance. Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain.

How Gilenya works
Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord. This limits nerve damage caused by MS.

What do you have to consider before using it?
Do not take Gilenya

Take special care with Gilenya
Talk to your doctor before taking Gilenya:

Slow heart rate (bradycardia) and irregular heartbeat: At the beginning of treatment, Gilenya causes the heart rate to slow down. As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, tell your doctor, because you may need treatment right away. Gilenya can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal in less than one day. Slow heart rate usually returns to normal within one month.

Your doctor will ask you to stay at the surgery or clinic for 6 hours after taking the first dose of Gilenya so that appropriate measures can be taken in the event of side effects that occur at the start of treatment. The same applies if you are resuming treatment after a break of more than two weeks.

If you have an irregular or abnormal heartbeat or a history of sudden loss of consciousness, your condition may worsen temporarily with Gilenya. If any of this applies to you, your doctor may check your heart before you start treatment with Gilenya.

The same applies if you have a slow heart rate (less than 55 beats per minute), or if you are taking medicines called beta blockers (which slow the heartbeat).

If you have never had chickenpox: If you have never had chickenpox, your doctor may want to check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, you may need a vaccination before you start treatment with Gilenya. If this is the case, your doctor will delay the start of treatment with Gilenya by one month.

Infections: Gilenya lowers the white blood cell count (particularly the lymphocyte count). White blood cells fight infection. While you are taking Gilenya (and for up to 2 months after you stop taking it), you may