Gilenya for Multiple Sclerosis

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Gilenya (fingolimod) was the first oral disease-modifying therapy for relapsing forms of multiple sclerosis (MS). It's a prescription immunosuppressive drug that's believed to work by binding to and trapping certain immune cells in your lymph nodes. This prevents the immune cells from traveling to the brain and spinal cord and attacking myelin and nerve fibers, which is what leads to symptoms of MS.

While Gilenya is convenient and effective, it does come with certain risks that need to be taken into consideration when deciding whether or not to take this drug, including a possible cardiac reaction after the first dose.

Indications

As a disease-modifying therapy (DMT), Gilenya is aimed at slowing the progression of MS rather than managing the symptoms.

Most other DMTs for MS are given by infusion or injection. The fact that Gilenya comes in pill form makes it much more convenient. Since Gilenya's approval by the U.S. Food and Drug Administration (FDA) in 2010, several other oral DMTs have come on the market.

Gilenya is also being studied as a potential treatment for progressive forms of MS as well as numerous autoimmune and inflammatory diseases, transplant rejection, stroke, and cancer.

Effectiveness

A 2017 review of literature on Gilenya examined 34 studies. Researchers say evidence suggested that the drug:

  • Improved outcomes compared to the pre-treatment period
  • Was more effective than interferon drugs (Avonex, Betaseron, Rebif), Copaxone or Glatopa (glatiramer acetate)
  • Had inconsistent results when compared to Tysabri (natalizumab)

Researchers concluded that there's good evidence of Gilenya's effectiveness.

A 2017 study focused on microglial activation, which is an important aspect of MS. Microglia are white-matter brain cells that are part of the central nervous system's immune response. However, they're also believed to cause chronic inflammatory activity, which is damaging.

In MS, microglial activation is associated with lesions but is also found in other areas of white matter and in gray matter, which is made up of neurons. It's also believed to be linked to neurodegeneration and the progression of MS.

The study found that Gilenya reduced microglial activation at the site of lesions, but it didn't affect it in other areas of the brain.

Researchers suspect that in the short term, Gilenya is effective because it prevents inflammatory activity at the site of lesions.

Brain volume loss (BVL) is another important factor of MS. According to a review of studies on this feature of the disease, Gilenya has been shown in multiple trials to reduce BVL by about one third when compared to placebo or interferon beta 1-a drugs (Avonex, Rebif). However, in a study on primary progressive MS, the drug appeared to be no better than placebo in preventing BVL.

Dosage

Standard dosing for Gilenya is 0.5 milligrams (mg), taken once a day. You can take it with or without food.

The dosage is the same for adults and children over 10. Gilenya's safety and effectiveness haven't been established in younger children.

Side Effects

Some common side effects include:

  • Headache
  • Abnormal liver tests
  • Diarrhea
  • Cough
  • Influenza
  • Sinusitis
  • Back pain
  • Abdominal pain
  • Limb pain

Children taking Gilenya may be at higher risk of seizure on Gilenya than on injectable treatments.

More serious but rare side effects include:

  • Slowed heart rate
  • Thyroid problems
  • Problems with your liver, lungs, or eyes
  • Encephalopathy (brain damage or dysfunction)
  • Increased risk of infection, including herpes and Epstein-Barr viral infections, and cryptococcal infection (fungal)
  • Severe worsening (rebound) of MS after going off the drug

You Are Not Alone

Treatment decisions are complicated. By involving your neurologist and your loved ones, you can weigh the risks and benefits of taking Gilenya as a team. Staying in touch with your doctor means you can address any side effects you may have right away.

Testing and Monitoring

Before you start taking Gilenya, your doctor will likely order several tests, including:

  • Blood cell test
  • Liver function blood test
  • Eye exam
  • Skin exam
  • Chickenpox immunity blood test

Some of the tests may be repeated occasionally while you're on the drug, if it's prescribed to you. Lung function tests may be ordered if you experience any breathing problems after starting Gilenya. 

Because one of the potential side effects of Gilenya is a slowed heart rate, you must take your first dose of Gilenya in a hospital setting, so you can be closely monitored and treated if there is a problem. You will also have your blood pressure and heart rate monitored constantly for at least six hours after your first dose. This effect only happens after the first dose. The heart rate generally begins returning to normal after about six hours.

Considerations and Contraindications

Gilenya should not be used if you recently experienced:

You also shouldn't take it if you're on medications that change your heart rhythm.

You should also tell your doctor if you have a history of fainting, diabetes, liver or kidney disease, asthma or another breathing disorder, or a current infection.

Gilenya is a "pregnancy category C" medication, meaning that it caused some fetal harm in animal studies; the effect in humans is unknown. If you are thinking of becoming pregnant, be sure to tell your doctor. You should go off Gilenya at least two months before trying to conceive. 

Vaccines

As Gilenya is an immunosuppressant, you should not receive a live vaccine while using Gilenya and for two months after stopping Gilenya, unless your doctor approves it.

For example, if you are going for your annual flu shot, opt for the inactivated influenza vaccine (flu shot) and not the live attenuated influenza vaccine (nasal spray).

Cost

Gilenya is expensive—about $8,580 per month—but there are some resources to help you.

To determine if Gilenya is covered under your insurance plan, or if you qualify for financial assistance to obtain Gilenya, you can contact Novartis' patient assistance program, The Gilenya GO Program, at 1-800-GILENYA (1-800-445-3692).

A Word From Verywell

Starting a new medication for your MS is a difficult decision and one that should be carefully discussed with your doctor and loved ones. While a number of people with MS may be eager to take an oral medication—as opposed to injecting themselves with more traditional disease-modifying therapies—be aware that some neurologists still prefer to wait until their patients are "failing" on their current medication before switching them to Gilenya.

The good news is that treatment options for MS have expanded and more new options are in the pipeline.

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