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Gilenya (Gilenia) for Multiple Sclerosis - MS Pill Gilenya Side Effects & Cost

Updated on September 6, 2012

Gilenya Benefits

Novartis' Gilenya (formerly spelled Gilenia, generic name fingolimod) is the first treatment for multiple sclerosis that patients take as a once-daily pill (0.5 mg capsules). Gilenya does not cure MS, but it reduces the frequency of MS relapses (flare-ups) by a novel mode of action different from all currently marketed MS therapies.

In Multiple Sclerosis (MS), white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to "unlock the lymph node door", resulting in less inflammatory damage to the nerve cells. The white blood cell retention is reversible if Gilenya treatment is stopped.

Gilenya is a medication from Novartis, headquartered in Basel, Switzerland.
Gilenya is a medication from Novartis, headquartered in Basel, Switzerland.

Novartis is now the only company to offer an oral MS drug. Studies have also demonstrated that Gilenya works better than some of its competitors at tamping down the symptoms of MS. One of the pivotal studies used to approve Gilenya showed the drug to be superior to Biogen's Avonex in preventing MS relapses.

Gilenya Side Effects

However, the new MS pill has a side effect profile that may make doctors hesitant to use Gilenya instead of older, more established MS drugs. The most common side effects with Gilenya are headaches, flu, cough, diarrhea, back pain and abnormal liver tests.

Gilenya can increase your risk of serious infections because Gilenya lowers the number of lymphocytes (white blood cells) in your blood. 

In clinical trials, side effects linked to Gilenya were:

  • Elevated liver enzymes - Gilenya may cause liver problems. A doctor should do blood tests to check a patient's liver enzymes levels before he starts taking Gilenya. Patients should contact their doctor right away if they experience nausea, vomiting, stomach pain, loss of appetite, tiredness, dark urine, or if their skin or the whites of their eyes turn yellow.
  • Macular edema (swelling of the central portion of the retina, causing distorted vision) - Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). So patients may not notice the symptoms of macular edema. Macular edema usually starts in the first 3 to 4 months after taking Gilenya. A doctor should test a patient's vision before they start taking the medication and 3-4 months after, or any time they notice vision changes during treatment. Risk of macular edema may be higher if a patient has diabetes or has had uveitis (an inflammation of the eye). Patients should contact their doctor if they experience blurriness, shadows or a blind spot in the center of their vision, sensitivity to light or unusually coloured vision.
  • Elevated blood pressure
  • Shortness of breath - Some patients who take Gilenya have shortness of breath. Patients should call their doctor right away if they have trouble breathing.
  • Bronchitis
  • Diarrhea
  • Bradycardia (slowing of the heartbeat) - Gilenya can cause the heart rate to slow down, especially right after the first dose. The heart rate will usually slow down the most about six hours after one takes their first dose of Gilenya. Patients might feel dizzy, tired or be aware of a slow irregular heartbeat if their heart rate slows down. A doctor will watch his patient for the first six hours after he takes the first dose to see if he has any serious side effects. A patient's slow heart rate will usually return to normal within one month after he start taking Gilenya. Patients should call their doctor if at any time they experience dizziness, tiredness or a slow and/or irregular heartbeat.

Two fatal herpes infections occurred among MS patients treated with Gilenya at doses of 1.25 mg (2.5 times the 0.5 mg dose for which the FDA approved Gilenya).

But overall, it seems the drug's benefits outweighed its risks among the more than 2,600 MS patients who took the drug in clinical trials.

Cost of Gilenya

The cost of Gilenya capsules has not been released yet. But according to Bloomberg, a spokesman of Novartis told them that Gilenya will cost $4,000 a month in the US. It will be more expensive than injectable competitors such as Avonex, Rebif and Copaxone, which cost between about $2,800 and $3,200 for a standard month’s supply.

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    • profile image

      mammy06 

      6 years ago

      If you are on Gilenya, you can apply for assistance program and they will help you with the cost. They help me and it is VERY helpful.

    • profile image

      painguy 

      6 years ago

      Are there any updates or is there any GOOD news regarding this? My better half is on Gilenya and starts Medicare in January and with a monthly cost of $4,000+ for the drug it is ridiculous. Too much SSD to qualify for Medicaid, but the amount that Novartis charges for the drug each month is more than 2.5 times monthly income! How does anyone pay this thing and also pay for those wild extras like, oh, food and shelter?

      Any ideas please contact me!

    • profile image

      fellow_mser 

      7 years ago

      Joyce please contact me ektullis919@yahoo.com

    • profile image

      michelle 

      7 years ago

      Yes, I agree. Many of the M.S. pts are so debilitated they cannot even hold a job. Who's to pay for the medication for them? They are coming up with some hopeful medications however, they do not keep in mind how many of these patients will not be able to even afford to purchase them.

    • profile image

      Joyce 

      7 years ago

      It’s going on five months now since I stopped taking the injectable MS therapy drug, Rebif, as my disability income and supplement for my fourteen year-old daughter just barely put me over the poverty level, causing me to no longer qualify for Medicaid in my state, Illinois. And, the Medicare Part D 25% co-pay for the Rebif $3,028 monthly price tag is out of the question, not to mention the ever hovering Medicare Part D donut hole. The disappointment I feel over the $4,000 monthly price of Gilenya borders on hopelessness. I get the feeling that whatever drug the researchers come up with, it will always be unattainable for most of the people that need it. Isn’t there some other way that the pharmaceutical companies can recoup their research expenses than gouging the victims of this painful, unpredictable and debilitating disease?

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