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Gilenya (Fingolimod): 9 Answers Inc. Uses, Side Effects, and Cost

Answers to the most frequently asked questions about Gilenya (Fingolimod)

Gilenya (Fingolimod) is used to treat the relapsing forms of MS as it contains the drug fingolimod. The drug fingolimod works by decreasing the action of immune cells that may cause nerve damage. It is used to prevent episodes of symptoms and slow the worsening disability in adults and children 10 years of age with relapsing-remitting forms (period of disease in which the nerves do not function normally) of MS.

  1. What is Gilenya?
  2. What is Gilenya used for? 
  3. Is Gilenya available in the US and UK? 
  4. How does Gilenya work? 
  5. What are the side effects of Gilenya?
  6. What warnings and precautions are there for taking Gilenya?
  7. How long does it take for Gilenya to work? 
  8. How often do I take Gilenya?
  9. How much does Gilenya cost?

1. What is Gilenya?

Gilenya is a prescription medicine used to treat relapsing forms of Multiple Sclerosis (MS), in adults as well as children ages 10 years and older.

MS is a neurological condition where your immune system attacks myelin, the protective layer on nerve fibers of the central nervous system. As a result of your immune system attacking your nerves, the damage interferes with messages being sent from the brain to the body. It is a disease where nerves do not function normally and people with MS can experience weakness, numbness, loss of coordination, and difficulty with vision and speech.

Gilenya is used to treat the relapsing forms of MS as it contains the drug fingolimod. The drug fingolimod works by decreasing the action of immune cells that may cause nerve damage. It is used to prevent episodes of symptoms and slow the worsening disability in adults and children 10 years of age with relapsing-remitting forms (period of disease in which the nerves do not function normally) of MS.

2. What is Gilenya used for? 

Gilenya (fingolimod) is medication used to treat the following relapsing forms of MS:

  • Relapsing-remitting MS
  • Secondary progressive MS that is active (meaning new symptoms are occurring)

Gilenya is also used to treat clinically isolated syndrome (CIS). CIS is an episode of neurological symptoms that signify the beginning of multiple sclerosis (MS). Symptoms vary, it may involve one or multiple symptoms.

3. Is Gilenya available in the US and UK? 

Yes, Gilenya (fingolimod) is a prescription medicine and was approved by regulators in the UK to treat highly active relapsing remitting multiple sclerosis in patients unresponsive to an interferon injection. The first oral treatment for multiple sclerosis was made available in the UK in 2011 following the launch of Novartis' Gilenya on the market, offering patients another medication option against the disease.

According to Multiple Sclerosis Society , you can be prescribed Gildenya if you have the same or an increased number of relapses despite treatment.

Gilenya (fingolimod) is approved in the US. In 2020, the FDA approved 3 new generic versions of Gilenya. Gilenya was first approved in 2010 by the FDA.

4. How does Gilenya work? 

Gilenya works by blocking the capacity of lymphocytes (white blood cells which exist in the lymphatic system) to escape from lymph codes. The fingolimod in Gilenya exerts its effects in multiple sclerosis by decreasing the migration of lymphocytes into the brain and spinal cord (central nervous system). This means fewer of them get into your brain and spinal cord where they would attack the covering (myelin) around your nerves. By preventing the lymphocytes from crossing into the central nervous system, Gilenya prevents the lymphocytes from causing inflammation and damage. As well as this, Gilenya medication helps decrease the number of episodes of worsening and may prevent or delay disability.

Gilenya: What is it and How Does it Work? - National MS Society Disclaimer: This is a third-party video and may contain advertisements

5. What are the side effects of Gilenya?

Gilenya may cause side effects that are mild or serious. The following list below includes some of the main side effects that have been reported with Gilenya use. For information about other potential side effects of the drug, talk with your doctor or pharmacist.

Symptoms can range from mild to serious

A list of mild side effects:

  • Headache
  • Blurred vision
  • Diarrhea
  • Cough
  • Chills
  • Infections, such as sinus infections or the flu
  • Back pain
  • Abdominal (belly) pain
  • Joint pain
  • Nausea
  • Difficulty sleeping
  • Increased liver enzymes

A list of more serious side effects:

Gilenya may cause serious side effects in some patients. Please speak to your doctor or pharmacist if you experience any of the following symptoms whilst taking Gilenya.

  • Heart rhythm abnormalities
  • Serious infections, such as: pneumonia, meningitis and shingle
  • Hypertension (high blood pressure)
  • Liver damage
  • Trouble breathing
  • Allergic reactions

6. What warnings and precautions are there for taking Gilenya?

  1. Slow heart rate when you first start taking Gilenya.

Gilenya can cause your heart rate to slow down, especially after you take your first dose. You will be in hospital and have a test as well as checking the electrical activity of your heart before you take your first dose of Gilenya.

  1. Pregnancy.

Ensure you consult with your doctor before getting pregnant. You should avoid becoming pregnant while taking Gilenya or in the two months after you stop taking it because of the risk of harm to the baby.

  1. Infections

Gilenya can increase the rate of infections, therefore, it is recommended not to receive any live vaccines during treatment with Gilenya and for 2 months after having taken Gilenya. Talk to your doctor before you receive a vaccine during treatment and for 2 months after treatment with Gilenya.

  1. Heart problems

If you have had a heart attack, irregular heart rhythms or a certain type of heart failure in the last 6 months, it is not recommended to take Gilenya.

7. How long does it take for Gilenya to work? 

Research has shown that there is a decrease in blood lymphocyte count of approximately 60% of baseline within four to six hours of the first dose of Gilenya.

Gilenya starts to work as soon as you take your first dose. It can take weeks or even months before you notice improvement with your symptoms.

8. How often do I take Gilenya?

In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the optimal dosage of Gilenya is 0.5 mg orally once daily.

In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage of GILENYA is 0.25 mg orally once daily.

9. How much does Gilenya cost?

In the UK, Gilenya can be prescribed if you are still having relapses after taking another DMD (disease modifying therapies). Gilenya also can be prescribed if you have very active MS (two or more disabling relapses in one year and MRI evidence of new areas of MS activity)

In the US, the cost for a 0.5 mg Gilenya oral capsule is around $8,580 for a supply of 30 capsules, depending on the pharmacy you visit. This pricing is for cash paying customers and is not valid with insurance plans.


The content on this page is provided for informational purposes only. If you have any questions or concerns about your treatment, you should talk to your doctor, pharmacist, or healthcare professional. This is particularly important if you are taking multiple medications or have any existing medical conditions.

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