This thread just showed up in my daily google alert email for the topic of Gilenya and I just thought I would pop in to say that I have been on Gilenya since the TRANSFORMS trial. Saturday will be my 4th anniversary.
I can't tell you what tests are performed prior to getting on G now that it has been approved but during the trials we had yearly dermatology exams, eye exams every 3 or 6 months, blood work every 3 months, an annual MRI, and a pulmonary function test every 3 or 6 months. We also had an EKG and I think you will be tested for your antibodies to Chiken Pox.
The side effects I experienced were mild and disappeared after 5-6 months. They included:
1. Drop in heart rate of 14 bpm upon first dose which recovered after 6 hours.
2. Increase in upper respiratory infections (I was sick with a head cold at least 1ce a month for the first 6 months).
3. Increase in urinary tract infections (I had one of those just about every month the first 6 months as well.)
4. I had 1 blood test come back with elevated liver enzymes out of all 4 years worth of tests. It came on the heels of a weekend I spent helping a friend prepare Jello shooters for a party and I sampled a couple. I"m not normally a drinker. I didn't do it again and my blood work returned to normal.
As far as results, I have gone from walking with 2 canes at the start of the trial and relapsing every 3 months to no longer needing a cane, being able to run short distances, and I have not had a relapse since April '07.
It was the best decision I'd ever made for my own personal MS. Everyone's results may vary, and it may or may not work out for you, but I thought I would share my results.
I am a member of the Facebook Gilenya Support Group and try to participate on a daily basis. We encourage anyone interesting in taking it and those already on it to join us there.
For answers about side effects and risks vs benefits however, no internet forum or group will take the place of talking to your doctor or seeking answers directly from Novartis.
Hope that helps.
