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

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.

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.

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.

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.