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.

Gilenya Approval History

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.

What is Multiple Sclerosis?

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:

  • Relapsing-Remitting MS (RRMS) is the most common type, affecting about 85% of patients. RRMS causes temporary flare-ups or exacerbations when new symptoms appear.
  • Secondary-Progressive MS (SPMS) is marked by symptoms that steadily worsen over time, with or without relapses or remissions. The majority of patients with RRMS will eventually progress to SPMS.
  • Primary-Progressive MS (PPMS) causes slowly worsening symptoms from the beginning, with no remission or relapse.
  • Progressive-Relapsing MS (RRMS) only occurs in about 5% of patients. It is characterized by a steadily worsening disease state from the beginning, with acute relapses but no remissions, with or without recovery.

How is Gilenya Used?

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:

  • Severe heart failure (that required hospitalization)
  • “AV block” or sick sinus syndrome (unless the patient has a pacemaker)
  • Long QT syndrome
  • Serious heart problems, including recent (within the past 6 months) heart attack, stroke, “mini-stroke” or TIA, unstable angina or other serious heart problem.

Additionally, patients who are allergic to fingolimod should not take Gilenya.

Gilenya Side Effects

Gilenya may cause the following severe adverse reactions:

  • Low heart rate,  also called bradycardia or bradyarrhythmia.
  • Infections, including a rare brain infection called progressive multifocal leukoencephalopathy.
  • Swelling in the eye called macular edema, which causes vision problems.

The following Gilenya side effects may occur as patients become accustomed to the medication:

  • Back pain
  • Pain or tenderness around the eyes and cheekbones
  • Stuffy nose
  • Decreased weight
  • Depression
  • Eye pain
  • Hair loss or thinning of the hair
  • Itching in the genitals or other skin areas
  • Itching skin
  • Lack or loss of strength
  • Scaling
  • Stomach pain
  • Skin rash, encrusted, scaly, and oozing
  • Weakness

Additionally, Gilenya patients should check with their doctor if they experience:

  • Blurred vision
  • Chills
  • Cough
  • Cough-producing mucus
  • Diarrhea
  • Difficult or labored breathing
  • Dizziness
  • Fever
  • General feeling of discomfort or illness
  • Headache
  • Joint pain
  • Loss of appetite
  • Muscle aches and pains
  • Nausea
  • Nervousness
  • Pounding in the ears
  • Runny nose
  • Shivering
  • Slow or fast heartbeat
  • Sore throat
  • Sweating
  • Tightness in the chest
  • Trouble sleeping
  • Unusual tiredness or weakness
  • Vomiting
  • Black, tarry stools
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Chest pain or discomfort
  • Cough
  • Severe, throbbing headache
  • Hoarseness
  • Lightheadedness, dizziness, or fainting
  • Lower back or side pain
  • Painful or difficult urination
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Swollen glands
  • Unusual bleeding or bruising
  • Confusion
  • Difficulty in speaking
  • Double vision
  • Inability to move the arms, legs, or facial muscles
  • Inability to speak
  • Slow speech
  • Weight loss
  • Yellow skin and eyes

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.

ALERT: Stopping Gilenya May Worsen MS Symptoms!

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.

  1. com (N.D.) “The 4 Types of MS”
  2. Novartis (October 2018) “Gilenya: Highlights of Prescribing Information”
  3. Novartis (October 2018) “Medication Guide”
  4. FDA (November 2018) “Gilenya (fingolimod): Drug Safety Communication – Severe Worsening of Multiple Sclerosis After Stopping the Medicine”
Last Modified: November 26, 2018

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