Gilenya (fingolimod) is approved to treat patients with the relapsing form of Multiple Sclerosis (MS). Patients should be aware, however, that they may experience severe worsening of MS symptoms when Gilenya is stopped.
The U.S. Food & Drug Administration (FDA) initially approved Gilenya in 2010, when it was cleared to reduce the frequency of clinical relapses and to delay the accumulation of physical disability in adults with relapsing MS.
In 2018, the FDA subsequently approved Gilenya to treat children and adolescents 10 years of age or older with relapsing MS.
MS affects 2.3 million people globally, making it the most widespread disabling neurological condition in the world. In fact, more than 1 million people in the United States live with MS, where roughly 200 new cases are diagnosed each week.
MS occurs when the immune system attacks the protective myelin sheath that covers nerve fibers, impeding the ability of the nerves to communicate with the rest of the body. Eventually, the nerves might deteriorate or become permanently damaged.
There are four types of MS:
Gilenya is an immunosuppressant. As such, it prevents immune cells (lymphocytes) from exiting the lymph nodes and crossing the blood-brain barrier to the brain and spinal cord.
There is no cure for MS. However, Gilenya will reduce the frequency of relapse symptoms.
Gilenya is a tablet taken once per day. But, because the drug can slow the heart rate, patients receive their first dose in the hospital. This allows for constant monitoring of blood pressure and heart rate for a full 6 hours.
Doctors should not prescribe Gilenya to patients with certain heart conditions, including:
Additionally, patients who are allergic to fingolimod should not take Gilenya.
Gilenya may cause the following severe adverse reactions:
The following Gilenya side effects may occur as patients become accustomed to the medication:
Additionally, Gilenya patients should check with their doctor if they experience:
Women of child-bearing age should use effective birth control while taking Gilenya, as the medication may harm an unborn baby. Do not breast feed while taking Gilenya.
For a complete rundown of Gilenya side effect and other important safety information, be sure to read the complete Medication Guide.
In November 2018, the FDA warned that patients who stopped treatment with Gilenya could experience severe worsening of MS symptoms. While rare, these worsening symptoms can result in permanent disability.
The FDA advised doctors to warn patients of this potential occurrence before they stop treatment with Gilenya. Additionally, doctors should carefully monitor patients once Gilenya is stopped, while those who experience an exacerbation of their MS symptoms. should be treated appropriately.
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